-
The Cochrane Database of Systematic... Sep 2018This is an update of a Cochrane Review first published in 2001.Hernias are protrusions of all or part of an organ through the body wall that normally contains it. Groin... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This is an update of a Cochrane Review first published in 2001.Hernias are protrusions of all or part of an organ through the body wall that normally contains it. Groin hernias include inguinal (96%) and femoral (4%) hernias, and are often symptomatic with discomfort. They are extremely common, with an estimated lifetime risk in men of 27%. Occasionally they may present as emergencies with complications such as bowel incarceration, obstruction and strangulation. The definitive treatment of all hernias is surgical repair, inguinal hernia repair being one of the most common surgical procedures performed. Mesh (hernioplasty) and the traditional non-mesh repairs (herniorrhaphy) are commonly used, with an increasing preference towards mesh repairs in high-income countries.
OBJECTIVES
To evaluate the benefits and harms of different inguinal and femoral hernia repair techniques in adults, specifically comparing closure with mesh versus without mesh. Outcomes include hernia recurrence, complications (including neurovascular or visceral injury, haematoma, seroma, testicular injury, infection, postoperative pain), mortality, duration of operation, postoperative hospital stay and time to return to activities of daily living.
SEARCH METHODS
We searched the following databases on 9 May 2018: Cochrane Colorectal Cancer Group Specialized Register, Cochrane Central Register of Controlled Trials (Issue 1), Ovid MEDLINE (from 1950), Ovid Embase (from 1974) and Web of Science (from 1900). Furthermore, we checked the WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov for trials. We applied no language or publication restrictions. We also searched the reference lists of included trials and review articles.
SELECTION CRITERIA
We included randomised controlled trials of mesh compared to non-mesh inguinal or femoral hernia repairs in adults over the age of 18 years.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Where available, we collected information on adverse effects. We presented dichotomous data as risk ratios, and where possible we calculated the number needed to treat for an additional beneficial outcome (NNTB). We presented continuous data as mean difference. Analysis of missing data was based on intention-to-treat principles, and we assessed heterogeneity using an evaluation of clinical and methodological diversity, Chi test and I statistic. We used GRADE to assess the quality of evidence for each outcome.
MAIN RESULTS
We included 25 studies (6293 participants) in this review. All included studies specified inguinal hernias, and two studies reported that femoral hernias were included.Mesh repair probably reduces the risk of hernia recurrence compared to non-mesh repair (21 studies, 5575 participants; RR 0.46, 95% CI 0.26 to 0.80, I = 44%, moderate-quality evidence). In absolute numbers, one hernia recurrence was prevented for every 46 mesh repairs compared with non-mesh repairs. Twenty-four studies (6293 participants) assessed a wide range of complications with varying follow-up times. Neurovascular and visceral injuries were more common in non-mesh repair groups (RR 0.61, 95% CI 0.49 to 0.76, I = 0%, NNTB = 22, high-quality evidence). Wound infection was found slightly more commonly in the mesh group (20 studies, 4540 participants; RR 1.29, 95% CI 0.89 to 1.86, I = 0%, NNTB = 200, low-quality evidence). Mesh repair reduced the risk of haematoma compared to non-mesh repair (15 studies, 3773 participants; RR 0.88, 95% CI 0.68 to 1.13, I = 0%, NNTB = 143, low-quality evidence). Seromas probably occur more frequently with mesh repair than with non-mesh repair (14 studies, 2640 participants; RR 1.63, 95% CI 1.03 to 2.59, I = 0%, NNTB = 72, moderate-quality evidence), as does wound swelling (two studies, 388 participants; RR 4.56, 95% CI 1.02 to 20.48, I = 33%, NNTB = 72, moderate-quality evidence). The comparative effect on wound dehiscence is uncertain due to wide confidence intervals (two studies, 329 participants; RR 0.55, 95% CI 0.12 to 2.48, I = 37% NNTB = 77, low-quality evidence). Testicular complications showed nearly equivocal results; they probably occurred slightly more often in the mesh group however the confidence interval around the effect was wide (14 studies, 3741 participants; RR 1.06, 95% CI 0.63 to 1.76, I = 0%, NNTB = 2000, low-quality evidence). Mesh reduced the risk of postoperative urinary retention compared to non-mesh (eight studies, 1539 participants; RR 0.53, 95% CI 0.38 to 0.73, I = 56%, NNTB = 16, moderate-quality evidence).Postoperative and chronic pain could not be compared due to variations in measurement methods and follow-up time (low-quality evidence).No deaths occurred during the follow-up periods reported in the seven studies (2546 participants) reporting this outcome (high-quality evidence).The average operating time was longer for non-mesh repairs by a mean of 4 minutes 22 seconds, despite wide variation across the studies regarding size and direction of effect, thus this result is uncertain (20 studies, 4148 participants; 95% CI -6.85 to -1.60, I= 97%, very low-quality evidence). Hospital stay may be shorter with mesh repair, by 0.6 days (12 studies, 2966 participants; 95% CI -0.86 to -0.34, I = 98%, low-quality evidence), and participants undergoing mesh repairs may return to normal activities of daily living a mean of 2.87 days sooner than those with non-mesh repair (10 studies, 3183 participants; 95% CI -4.42 to -1.32, I = 96%, low-quality evidence), although the results of both these outcomes are also limited by wide variation in the size and direction of effect across the studies.
AUTHORS' CONCLUSIONS
Mesh and non-mesh repairs are effective surgical approaches in treating hernias, each demonstrating benefits in different areas. Compared to non-mesh repairs, mesh repairs probably reduce the rate of hernia recurrence, and reduce visceral or neurovascular injuries, making mesh repair a common repair approach. Mesh repairs may result in a reduced length of hospital stay and time to return to activities of daily living, but these results are uncertain due to variation in the results of the studies. Non-mesh repair is less likely to cause seroma formation and has been favoured in low-income countries due to low cost and reduced availability of mesh materials. Risk of bias in the included studies was low to moderate and generally handled well by study authors, with attention to details of allocation, blinding, attrition and reporting.
Topics: Activities of Daily Living; Adult; Hernia, Femoral; Hernia, Inguinal; Herniorrhaphy; Humans; Length of Stay; Operative Time; Postoperative Complications; Randomized Controlled Trials as Topic; Secondary Prevention; Surgical Mesh
PubMed: 30209805
DOI: 10.1002/14651858.CD011517.pub2 -
The Cochrane Database of Systematic... Oct 2019Dislocation of the acromioclavicular joint is one of the most common shoulder injuries in a sport-active population. The question of whether surgery should be used... (Review)
Review
BACKGROUND
Dislocation of the acromioclavicular joint is one of the most common shoulder injuries in a sport-active population. The question of whether surgery should be used remains controversial. This is an update of a Cochrane Review first published in 2010.
OBJECTIVES
To assess the effects (benefits and harms) of surgical versus conservative (non-surgical) interventions for treating acromioclavicular dislocations in adults.
SEARCH METHODS
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to June 2019), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2019, Issue 6), MEDLINE (1946 to June 2019), Embase (1980 to June 2019), and LILACS (1982 to June 2019), trial registries, and reference lists of articles. There were no restrictions based on language or publication status.
SELECTION CRITERIA
We included all randomised and quasi-randomised trials that compared surgical with conservative treatment of acromioclavicular dislocation in adults.
DATA COLLECTION AND ANALYSIS
At least two review authors independently performed study screening and selection, 'Risk of bias' assessment, and data extraction. We pooled data where appropriate and used GRADE to assess the quality of evidence for each outcome.
MAIN RESULTS
We included five randomised trials and one quasi-randomised trial. The included trials involved 357 mainly young adults, the majority of whom were male, with acute acromioclavicular dislocation. The strength of the findings in all studies was limited due to design features, invariably lack of blinding, that carry a high risk of bias. Fixation of the acromioclavicular joint using hook plates, tunnelled suspension devices, coracoclavicular screws, acromioclavicular pins, or (usually threaded) wires was compared with supporting the arm in a sling or similar device. After surgery, the arm was also supported in a sling or similar device in all trials. Where described in the trials, both groups had exercise-based rehabilitation. We downgraded the evidence for all outcomes at least two levels, invariably for serious risk of bias and serious imprecision.Low-quality evidence from two studies showed no evidence of a difference between groups in shoulder function at one year, assessed using the Disability of the Arm, Shoulder, and Hand questionnaire (DASH) (0 (best function) to 100 (worst function)): mean difference (MD) 0.73 points, 95% confidence interval (CI) -2.70 to 4.16; 112 participants. These results were consistent with other measures of function at one-year or longer follow-up, including non-validated outcome scores reported by three studies. There is low-quality evidence that function at six weeks may be better after conservative treatment, indicating an earlier recovery. Very low-quality evidence from one trial found no difference between groups in participants reporting pain at one year: risk ratio (RR) 1.32, 95% CI 0.54 to 3.19; 79 participants. There is very low-quality evidence that surgery may not reduce the risk of treatment failure, usually resulting in non-routine secondary surgery: 14/168 versus 15/174; RR 0.99, 95% CI 0.51 to 1.94; 342 participants, 6 studies. The main source of treatment failure was complications related to surgical implants in the surgery group and persistent symptoms, mainly discomfort, due to the acromioclavicular dislocation in the conservatively treated group.There is low-quality evidence from two studies that there may be little or no difference between groups in the return to former activities (sports or work) at one year: 57/67 versus 62/70; RR 0.96, 95% CI 0.85 to 1.10; 137 participants, 2 studies. Low-quality but consistent evidence from four studies indicated an earlier recovery in conservatively treated participants compared with those treated with surgery. There is low-quality evidence of no clinically important difference between groups at one year in quality of life scores, measured using the 36-item or 12-item Short Form Health Survey (SF-36 or SF-12) (0-to-100 scale, where 100 is best score), in either the physical component (MD -0.63, 95% CI -2.63 to 1.37; 122 participants, 2 studies) or mental component (MD 0.47 points, 95% CI -1.51 to 2.44; 122 participants). There is very low-quality and clinically heterogenous evidence of a greater risk of an adverse event after surgery: 45/168 versus 16/174; RR 2.82, 95% CI 1.65 to 4.82; 342 participants, 6 studies; I = 48%. Common adverse outcomes were hardware complications or discomfort (18.5%) and infection (8.7%) in the surgery group and persistent symptoms (7.1%), mainly discomfort, in the conservatively treated group. The majority of surgical complications occurred in older studies testing now-outdated devices known for their high risk of complications. The very low-quality evidence from one study (70 participants) means that we are uncertain whether there is a between-group difference in patient dissatisfaction with cosmetic results.It is notable that the evidence for function, return to former activities, and quality of life came from the two most recently conducted studies, which tested currently used devices and interventions in clearly defined participant populations that represented the commonly perceived population for which there is uncertainty over the use of surgery. There were insufficient data to conduct subgroup analysis relating to type of injury and whether surgery involved ligament reconstruction or not.
AUTHORS' CONCLUSIONS
There is low-quality evidence that surgical treatment has no additional benefits in terms of function, return to former activities, and quality of life at one year compared with conservative treatment. There is, however, low-quality evidence that people treated conservatively had improved function at six weeks compared with surgical management. There is very low-quality evidence of little difference between the two treatments in pain at one year, treatment failure usually resulting in secondary surgery, or patient satisfaction with cosmetic result. Although surgery may result in more people sustaining adverse events, this varied between the trials, being more common in techniques such as K-wire fixation that are rarely used today. There remains a need to consider the balance of risks between the individual outcomes: for example, surgical adverse events, including wound infection or dehiscence and hardware complication, against risk of adverse events that may be more commonly associated with conservative treatment such as persistent symptoms or discomfort, or both.There is a need for sufficiently powered, good-quality, well-reported randomised trials of currently used surgical interventions versus conservative treatment for well-defined injuries.
PubMed: 31604007
DOI: 10.1002/14651858.CD007429.pub3 -
Journal of Periodontology Dec 2022The use of biologics may be indicated for alveolar ridge preservation (ARP) and reconstruction (ARR), and implant site development (ISD). The present systematic review...
BACKGROUND
The use of biologics may be indicated for alveolar ridge preservation (ARP) and reconstruction (ARR), and implant site development (ISD). The present systematic review aimed to analyze the effect of autologous blood-derived products (ABPs), enamel matrix derivative (EMD), recombinant human platelet-derived growth factor-BB (rhPDGF-BB), and recombinant human bone morphogenetic protein-2 (rhBMP-2), on the outcomes of ARP/ARR and ISD therapy (i.e., alveolar ridge augmentation [ARA] and maxillary sinus floor augmentation [MSFA]).
METHODS
An electronic search for eligible articles published from January 2000 to October 2021 was conducted. Randomized clinical trials evaluating the efficacy of ABPs, EMD, rhBMP-2, and rhPDGF-BB for ARP/ARR and ISD were included according to pre-established eligibility criteria. Data on linear and volumetric dimensional changes, histomorphometric findings, and a variety of secondary outcomes (i.e., clinical, implant-related, digital imaging, safety, and patient-reported outcome measures [PROMs]) were extracted and critically analyzed. Risk of bias assessment of the selected investigations was also conducted.
RESULTS
A total of 39 articles were included and analyzed qualitatively. Due to the high level of heterogeneity across studies, quantitative analyses were not feasible. Most studies in the topic of ARP/ARR revealed that the use of biologics rendered similar results compared with conventional protocols. However, when juxtaposed to unassisted healing or socket filling using collagen sponges, the application of biologics did contribute to attenuate post-extraction alveolar ridge atrophy in most investigations. Additionally, histomorphometric outcomes were positively influenced by the application of biologics. The use of biologics in ARA interventions did not yield superior clinical or radiographic outcomes compared with control therapies. Nevertheless, ABPs enhanced new bone formation and reduced the likelihood of early wound dehiscence. The use of biologics in MSFA interventions did not translate into superior clinical or radiographic outcomes. It was observed, though, that the use of some biologics may promote bone formation during earlier stages of healing. Only four clinical investigations evaluated PROMs and reported a modest beneficial impact of the use of biologics on pain and swelling. No severe adverse events in association with the use of the biologics evaluated in this systematic review were noted.
CONCLUSIONS
Outcomes of therapy after post-extraction ARP/ARR and ARA in edentulous ridges were comparable among different therapeutic modalities evaluated in this systematic review. Nevertheless, the use of biologics (i.e., PRF, EMD, rhPDGF-BB, and rhBMP-2) in combination with a bone graft material generally results into superior histomorphometric outcomes and faster wound healing compared with control groups.
Topics: Humans; Tooth Socket; Sinus Floor Augmentation; Biological Products; Becaplermin; Alveolar Ridge Augmentation; Alveolar Process; Tooth Extraction
PubMed: 35841608
DOI: 10.1002/JPER.22-0069 -
Journal of Periodontology Mar 2020Orthodontic treatment can greatly impact the periodontium, especially in dentitions with a thin periodontal phenotype. Orthodontic tooth movement can result into...
BACKGROUND
Orthodontic treatment can greatly impact the periodontium, especially in dentitions with a thin periodontal phenotype. Orthodontic tooth movement can result into iatrogenic sequelae to these vulnerable anatomic conditions, such as development and exacerbation of bony dehiscence or fenestration defects, which can manifest loss of periodontal support and gingival recession (GR). This systematic review aimed to investigate whether periodontal phenotype modification therapy (PhMT) involving hard tissue augmentation (PhMT-b) or soft tissue augmentation (PhMT-s) has clinical benefits for patients undergoing orthodontic treatment.
METHODS
An electronic search was performed in two major databases for journals published in English language from January 1975 to January 2019 and a hand search of printed journals was also performed to identify human clinical trials reporting clinical and radiographic outcomes of patients receiving orthodontic treatment with or without hard and soft tissue augmentation procedures. Data were extracted and organized into tables for qualitative assessment.
RESULTS
Eight studies were identified evaluating the outcomes of PhMT in patients undergoing orthodontic therapy. Six studies evaluated patients receiving PhMT-b via corticotomy-assisted orthodontic therapy (CAOT) and simultaneous bone augmentation while the other two received PhMT-s before tooth movement. No studies investigated PhMT-b alone without CAOT and most studies focused on the mandibular anterior decompensation movements. There was high heterogeneity in the study design and inconsistency of the reported outcomes; therefore, a meta-analysis was not performed. Evidence at this moment supports CAOT with hard tissue augmentation accelerated tooth movement. However, only two studies provided direct comparison to support that CAOT with PhMT-b reduced the overall treatment time compared with conventional orthodontic treatment. No periodontal complications or evidence of severe root resorption were reported for both groups. Four studies provided radiographic assessment of the PhMT-b and demonstrated increased radiographic density or thicker facial bone after the treatment. Two studies reported an expanded tooth movement. One study reported an increase in keratinized tissue width post-CAOT plus PhMT-b, while another study with a 10-year follow-up showed a lower degree of relapse using the mandibular irregularity index when compared with conventional tooth movement alone. Two studies examined the effect of PhMT-s before orthodontic treatment. Unfortunately, no conclusions can be drawn because of the limited number of studies with contradicting outcomes.
CONCLUSIONS
Within the limited studies included in this systematic review, PhMT-b via particulate bone grafting together with CAOT may provide clinical benefits such as modifying periodontal phenotype, maintaining or enhancing facial bone thickness, accelerating tooth movement, expanding the scope of safe tooth movement for patients undergoing orthodontic tooth movement. The benefits of PhMT-s alone for orthodontic treatment remain undetermined due to limited studies available. However, PhMT-b appears promising and with many potential benefits for patients undergoing orthodontic tooth movement. There is a need for a higher quality of randomized controlled trials or case control studies with longer follow-up to investigate the effects of different grafting materials and surgical sites other than mandibular anterior region.
Topics: Bone Transplantation; Gingival Recession; Humans; Phenotype; Root Resorption; Tooth Movement Techniques; United States
PubMed: 31670836
DOI: 10.1002/JPER.19-0037 -
The Cochrane Database of Systematic... Mar 2019Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). While existing evidence for the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). While existing evidence for the effectiveness of NPWT remains uncertain, new trials necessitated an updated review of the evidence for the effects of NPWT on postoperative wounds healing by primary closure.
OBJECTIVES
To assess the effects of negative pressure wound therapy for preventing surgical site infection in wounds healing through primary closure.
SEARCH METHODS
We searched the Cochrane Wounds Specialised Register, CENTRAL, Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase, and EBSCO CINAHL Plus in February 2018. We also searched clinical trials registries for ongoing and unpublished studies, and checked reference lists of relevant included studies as well as reviews, meta-analyses, and health technology reports to identify additional studies. There were no restrictions on language, publication date, or setting.
SELECTION CRITERIA
We included trials if they allocated participants to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with another type of NPWT.
DATA COLLECTION AND ANALYSIS
Four review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and quality assessment according to GRADE methodology.
MAIN RESULTS
In this second update we added 25 intervention trials, resulting in a total of 30 intervention trials (2957 participants), and two economic studies nested in trials. Surgeries included abdominal and colorectal (n = 5); caesarean section (n = 5); knee or hip arthroplasties (n = 5); groin surgery (n = 5); fractures (n = 5); laparotomy (n = 1); vascular surgery (n = 1); sternotomy (n = 1); breast reduction mammoplasty (n = 1); and mixed (n = 1). In three key domains four studies were at low risk of bias; six studies were at high risk of bias; and 20 studies were at unclear risk of bias. We judged the evidence to be of low or very low certainty for all outcomes, downgrading the level of the evidence on the basis of risk of bias and imprecision.Primary outcomesThree studies reported mortality (416 participants; follow-up 30 to 90 days or unspecified). It is uncertain whether NPWT has an impact on risk of death compared with standard dressings (risk ratio (RR) 0.63, 95% confidence interval (CI) 0.25 to 1.56; very low-certainty evidence, downgraded once for serious risk of bias and twice for very serious imprecision).Twenty-five studies reported on SSI. The evidence from 23 studies (2533 participants; 2547 wounds; follow-up 30 days to 12 months or unspecified) showed that NPWT may reduce the rate of SSIs (RR 0.67, 95% CI 0.53 to 0.85; low-certainty evidence, downgraded twice for very serious risk of bias).Fourteen studies reported dehiscence. We combined results from 12 studies (1507 wounds; 1475 participants; follow-up 30 days to an average of 113 days or unspecified) that compared NPWT with standard dressings. It is uncertain whether NPWT reduces the risk of wound dehiscence compared with standard dressings (RR 0.80, 95% CI 0.55 to 1.18; very low-certainty evidence, downgraded twice for very serious risk of bias and once for serious imprecision).Secondary outcomesWe are uncertain whether NPWT increases or decreases reoperation rates when compared with a standard dressing (RR 1.09, 95% CI 0.73 to 1.63; 6 trials; 1021 participants; very low-certainty evidence, downgraded for very serious risk of bias and serious imprecision) or if there is any clinical benefit associated with NPWT for reducing wound-related readmission to hospital within 30 days (RR 0.86, 95% CI 0.47 to 1.57; 7 studies; 1271 participants; very low-certainty evidence, downgraded for very serious risk of bias and serious imprecision). It is also uncertain whether NPWT reduces incidence of seroma compared with standard dressings (RR 0.67, 95% CI 0.45 to 1.00; 6 studies; 568 participants; very low-certainty evidence, downgraded twice for very serious risk of bias and once for serious imprecision). It is uncertain if NPWT reduces or increases the risk of haematoma when compared with a standard dressing (RR 1.05, 95% CI 0.32 to 3.42; 6 trials; 831 participants; very low-certainty evidence, downgraded twice for very serious risk of bias and twice for very serious imprecision. It is uncertain if there is a higher risk of developing blisters when NPWT is compared with a standard dressing (RR 6.64, 95% CI 3.16 to 13.95; 6 studies; 597 participants; very low-certainty evidence, downgraded twice for very serious risk of bias and twice for very serious imprecision).Quality of life was not reported separately by group but was used in two economic evaluations to calculate quality-adjusted life years (QALYs). There was no clear difference in incremental QALYs for NPWT relative to standard dressing when results from the two trials were combined (mean difference 0.00, 95% CI -0.00 to 0.00; moderate-certainty evidence).One trial concluded that NPWT may be more cost-effective than standard care, estimating an incremental cost-effectiveness ratio (ICER) value of GBP 20.65 per QALY gained. A second cost-effectiveness study estimated that when compared with standard dressings NPWT was cost saving and improved QALYs. We rated the overall quality of the reports as very good; we did not grade the evidence beyond this as it was based on modelling assumptions.
AUTHORS' CONCLUSIONS
Despite the addition of 25 trials, results are consistent with our earlier review, with the evidence judged to be of low or very low certainty for all outcomes. Consequently, uncertainty remains about whether NPWT compared with a standard dressing reduces or increases the incidence of important outcomes such as mortality, dehiscence, seroma, or if it increases costs. Given the cost and widespread use of NPWT for SSI prophylaxis, there is an urgent need for larger, well-designed and well-conducted trials to evaluate the effects of newer NPWT products designed for use on clean, closed surgical incisions. Such trials should initially focus on wounds that may be difficult to heal, such as sternal wounds or incisions on obese patients.
Topics: Bandages; Blister; Hematoma; Humans; Negative-Pressure Wound Therapy; Orthopedic Procedures; Quality-Adjusted Life Years; Randomized Controlled Trials as Topic; Reoperation; Seroma; Skin Transplantation; Surgical Procedures, Operative; Surgical Wound Dehiscence; Surgical Wound Infection; Wound Healing; Wounds and Injuries
PubMed: 30912582
DOI: 10.1002/14651858.CD009261.pub4 -
The Cochrane Database of Systematic... Oct 2022There are several possible interventions for managing pressure ulcers (sometimes referred to as pressure injuries), ranging from pressure-relieving measures, such as... (Review)
Review
BACKGROUND
There are several possible interventions for managing pressure ulcers (sometimes referred to as pressure injuries), ranging from pressure-relieving measures, such as repositioning, to reconstructive surgery. The surgical approach is usually reserved for recalcitrant wounds (where the healing process has stalled, or the wound is not responding to treatment) or wounds with full-thickness skin loss and exposure of deeper structures such as muscle fascia or bone. Reconstructive surgery commonly involves wound debridement followed by filling the wound with new tissue. Whilst this is an accepted means of ulcer management, the benefits and harms of different surgical approaches, compared with each other or with non-surgical treatments, are unclear. This is an update of a Cochrane Review published in 2016.
OBJECTIVES
To assess the effects of different types of reconstructive surgery for treating pressure ulcers (category/stage II or above), compared with no surgery or alternative reconstructive surgical approaches, in any care setting.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search date was January 2022.
SELECTION CRITERIA
Published or unpublished randomised controlled trials (RCTs) that assessed reconstructive surgery in the treatment of pressure ulcers.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected the studies, extracted study data, assessed the risk of bias and undertook GRADE assessments. We would have involved a third review author in case of disagreement.
MAIN RESULTS
We identified one RCT conducted in a hospital setting in the USA. It enrolled 20 participants aged between 20 and 70 years with stage IV ischial or sacral pressure ulcers (involving full-thickness skin and tissue loss). The study compared two reconstructive techniques for stage IV pressure ulcers: conventional flap surgery and cone of pressure flap surgery, in which a large portion of the flap tip is de-epithelialised and deeply inset to obliterate dead space. There were no clear data for any of our outcomes, although we extracted some information on complete wound healing, wound dehiscence, pressure ulcer recurrence and wound infection. We graded the evidence for these outcomes as very low-certainty. The study provided no data for any other outcomes.
AUTHORS' CONCLUSIONS
Currently there is very little randomised evidence on the role of reconstructive surgery in pressure ulcer management, although it is considered a priority area. More rigorous and robust research is needed to explore this intervention.
Topics: Adult; Aged; Debridement; Humans; Middle Aged; Pressure Ulcer; Plastic Surgery Procedures; Wound Healing; Young Adult
PubMed: 36228111
DOI: 10.1002/14651858.CD012032.pub3 -
The Cochrane Database of Systematic... Nov 2017Surgeons who perform laparotomy have a number of decisions to make regarding abdominal closure. Material and size of potential suture types varies widely. In addition,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Surgeons who perform laparotomy have a number of decisions to make regarding abdominal closure. Material and size of potential suture types varies widely. In addition, surgeons can choose to close the incision in anatomic layers or mass ('en masse'), as well as using either a continuous or interrupted suturing technique, of which there are different styles of each. There is ongoing debate as to which suturing techniques and suture materials are best for achieving definitive wound closure while minimising the risk of short- and long-term complications.
OBJECTIVES
The objectives of this review were to identify the best available suture techniques and suture materials for closure of the fascia following laparotomy incisions, by assessing the following comparisons: absorbable versus non-absorbable sutures; mass versus layered closure; continuous versus interrupted closure techniques; monofilament versus multifilament sutures; and slow absorbable versus fast absorbable sutures. Our objective was not to determine the single best combination of suture material and techniques, but to compare the individual components of abdominal closure.
SEARCH METHODS
On 8 February 2017 we searched CENTRAL, MEDLINE, Embase, two trials registries, and Science Citation Index. There were no limitations based on language or date of publication. We searched the reference lists of all included studies to identify trials that our searches may have missed.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that compared suture materials or closure techniques, or both, for fascial closure of laparotomy incisions. We excluded trials that compared only types of skin closures, peritoneal closures or use of retention sutures.
DATA COLLECTION AND ANALYSIS
We abstracted data and assessed the risk of bias for each trial. We calculated a summary risk ratio (RR) for the outcomes assessed in the review, all of which were dichotomous. We used random-effects modelling, based on the heterogeneity seen throughout the studies and analyses. We completed subgroup analysis planned a priori for each outcome, excluding studies where interventions being compared differed by more than one component, making it impossible to determine which variable impacted on the outcome, or the possibility of a synergistic effect. We completed sensitivity analysis, excluding trials with at least one trait with high risk of bias. We assessed the quality of evidence using the GRADEpro guidelines.
MAIN RESULTS
Fifty-five RCTs with a total of 19,174 participants met the inclusion criteria and were included in the meta-analysis. Included studies were heterogeneous in the type of sutures used, methods of closure and patient population. Many of the included studies reported multiple comparisons.For our primary outcome, the proportion of participants who developed incisional hernia at one year or more of follow-up, we did not find evidence that suture absorption (absorbable versus non-absorbable sutures, RR 1.07, 95% CI 0.86 to 1.32, moderate-quality evidence; or slow versus fast absorbable sutures, RR 0.81, 95% CI 0.63 to 1.06, moderate-quality evidence), closure method (mass versus layered, RR 1.92, 95% CI 0.58 to 6.35, very low-quality evidence) or closure technique (continuous versus interrupted, RR 1.01, 95% CI 0.76 to 1.35, moderate-quality evidence) resulted in a difference in the risk of incisional hernia. We did, however, find evidence to suggest that monofilament sutures reduced the risk of incisional hernia when compared with multifilament sutures (RR 0.76, 95% CI 0.59 to 0.98, I = 30%, moderate-quality evidence).For our secondary outcomes, we found that none of the interventions reduced the risk of wound infection, whether based on suture absorption (absorbable versus non-absorbable sutures, RR 0.99, 95% CI 0.84 to 1.17, moderate-quality evidence; or slow versus fast absorbable sutures, RR 1.16, 95% CI 0.85 to 1.57, moderate-quality evidence), closure method (mass versus layered, RR 0.93, 95% CI 0.67 to 1.30, low-quality evidence) or closure technique (continuous versus interrupted, RR 1.13, 95% CI 0.96 to 1.34, moderate-quality evidence).Similarily, none of the interventions reduced the risk of wound dehiscence whether based on suture absorption (absorbable versus non-absorbable sutures, RR 0.78, 95% CI 0.55 to 1.10, moderate-quality evidence; or slow versus fast absorbable sutures, RR 1.55, 95% CI 0.92 to 2.61, moderate-quality evidence), closure method (mass versus layered, RR 0.69, 95% CI 0.31 to 1.52, moderate-quality evidence) or closure technique (continuous versus interrupted, RR 1.21, 95% CI 0.90 to 1.64, moderate-quality evidence).Absorbable sutures, compared with non-absorbable sutures (RR 0.49, 95% CI 0.26 to 0.94, low-quality evidence) reduced the risk of sinus or fistula tract formation. None of the other comparisons showed a difference (slow versus fast absorbable sutures, RR 0.88, 95% CI 0.05 to 16.05, very low-quality evidence; mass versus layered, RR 0.49, 95% CI 0.15 to 1.62, low-quality evidence; continuous versus interrupted, RR 1.51, 95% CI 0.64 to 3.61, very low-quality evidence).
AUTHORS' CONCLUSIONS
Based on this moderate-quality body of evidence, monofilament sutures may reduce the risk of incisional hernia. Absorbable sutures may also reduce the risk of sinus or fistula tract formation, but this finding is based on low-quality evidence.We had serious concerns about the design or reporting of several of the 55 included trials. The comparator arms in many trials differed by more than one component, making it impossible to attribute differences between groups to any one component. In addition, the patient population included in many of the studies was very heterogeneous. Trials included both emergency and elective cases, different types of disease pathology (e.g. colon surgery, hepatobiliary surgery, etc.) or different types of incisions (e.g. midline, paramedian, subcostal).Consequently, larger, high-quality trials to further address this clinical challenge are warranted. Future studies should ensure that proper randomisation and allocation techniques are performed, wound assessors are blinded, and that the duration of follow-up is adequate. It is important that only one type of intervention is compared between groups. In addition, a homogeneous patient population would allow for a more accurate assessment of the interventions.
Topics: Abdominal Wound Closure Techniques; Fistula; Humans; Incisional Hernia; Laparotomy; Randomized Controlled Trials as Topic; Surgical Wound Dehiscence; Surgical Wound Infection; Suture Techniques; Sutures
PubMed: 29099149
DOI: 10.1002/14651858.CD005661.pub2 -
World Journal of Surgery Dec 2022Fascial dehiscence (FD) and incisional hernia (IH) pose considerable risks to patients who undergo abdominal surgery, and many preventive strategies have been applied to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Fascial dehiscence (FD) and incisional hernia (IH) pose considerable risks to patients who undergo abdominal surgery, and many preventive strategies have been applied to reduce this risk. An accurate predictive model could aid identification of high-risk patients, who could be targeted for particular care. This study aims to systematically review existing FD and IH prediction models.
METHODS
Prediction models were identified using pre-specified search terms on SCOPUS, PubMed, and Web of Science. Eligible studies included those conducted in adult patients who underwent any kind of abdominal surgery, and reported model performance. Data from the eligible studies were extracted, and the risk of bias (RoB) was assessed using the PROBAST tool. Pooling of C-statistics was performed using a random-effect meta-analysis. [Registration: PROSPERO (CRD42021282463)].
RESULTS
Twelve studies were eligible for review; five were FD prediction model studies. Most included studies had high RoB, especially in the analysis domain. The C-statistics of the FD and IH prediction models ranged from 0.69 to 0.92, but most have yet to be externally validated. Pooled C-statistics (95% CI) were 0.80 (0.74, 0.86) and 0.81 (0.75, 0.86) for the FD (external-validation) and IH prediction model, respectively. Some predictive factors such as body mass index, smoking, emergency operation, and surgical site infection were associated with FD or IH occurrence and were included in multiple models.
CONCLUSIONS
Several models have been developed as an aid for FD and IH prediction, mostly with modest performance and lacking independent validation. New models for specific patient groups may offer clinical utility.
Topics: Adult; Humans; Incisional Hernia; Surgical Wound Infection; Bias
PubMed: 36102959
DOI: 10.1007/s00268-022-06715-6 -
European Journal of Cardio-thoracic... Oct 2021Mitral and tricuspid ring annuloplasty dehiscence with consequent recurrent valve regurgitation is a rare but challenging procedural failure. The incidence and...
OBJECTIVES
Mitral and tricuspid ring annuloplasty dehiscence with consequent recurrent valve regurgitation is a rare but challenging procedural failure. The incidence and predisposing risk factors for annuloplasty ring dehiscence include technical and pathological ones.
METHODS
A systematic database search with pooled analysis was conducted of original articles that only included dehiscence rate of mitral and tricuspid ring in EMBASE, MEDLINE, Cochrane database and Google Scholar, from inception to November 2020. The outcomes included were dehiscence rate in mitral and tricuspid, type of ring implanted, dehiscence rate by pathology and by ring size and shape.
RESULTS
Our search yielded 821 relevant studies. Thirty-three studies met the inclusion criteria with a total of 10 340 patients (6543 mitral, 1414 tricuspid) of which 87 (mitral) and 30 (tricuspid) had dehiscence. Overall, dehiscence rate was 1.43%, diagnosed at a median of 4.5 ± 1.0 months postoperatively. A significant difference in mitral dehiscence rate was found by ring type (semi-rigid 1.86%, rigid 2.32%; flexible 0.43%; P < 0.001). There was no significant difference in rate of dehiscence by ring size (P = 0.067) and shape in mitral (P = 0.281) but there was higher dehiscence rate in ischaemic compared to non-ischaemic mitral regurgitation (3.91% vs 1.63%; P = 0.022). Among tricuspid studies, 9 of 10 studies did not report any dehiscence.
CONCLUSIONS
Although rigid, semi-rigid and flexible annuloplasty rings provide acceptable valve repair outcomes, mitral annuloplasty ring dehiscence is clinically more common among rigid rings. Understanding the multifactorial nature of ring dehiscence will help in identifying the patients at high risk and improve their clinical outcomes.
Topics: Heart Valve Prosthesis; Heart Valve Prosthesis Implantation; Humans; Mitral Valve; Mitral Valve Annuloplasty; Mitral Valve Insufficiency; Prosthesis Design; Treatment Outcome; Tricuspid Valve Insufficiency
PubMed: 33880496
DOI: 10.1093/ejcts/ezab178 -
Periodontology 2000 Oct 2023Bone regeneration is often required concomitant with implant placement to treat a bone fenestration, a dehiscence, and for contouring. This systematic review assessed... (Meta-Analysis)
Meta-Analysis Review
Bone regeneration is often required concomitant with implant placement to treat a bone fenestration, a dehiscence, and for contouring. This systematic review assessed the impact of different biomaterials employed for guided bone regeneration (GBR) simultaneous to implant placement on the stability of radiographic peri-implant bone levels at ≥12 months of follow-up (focused question 1), as well as on bone defect dimension (width/height) changes at re-assessment after ≥4 months (focused question 2). Only randomized controlled trials (RCTs) and controlled clinical trials (CCTs) that compared different biomaterials for GBR were considered. A Bayesian network meta-analysis (NMA) was performed using a random-effects model. A ranking probability between treatments was obtained, as well as an estimation of the surface under the cumulative ranking value (SUCRA). Overall, whenever the biological principle of GBR was followed, regeneration occurred in a predictable way, irrespective of the type of biomaterial used. A lower efficacy of GBR treatments was suggested for initially large defects, despite the trend did not reach statistical significance. Regardless of the biomaterial employed, a certain resorption of the augmented bone was observed overtime. While GBR was shown to be a safe and predictable treatment, several complications (including exposure, infection, and soft tissue dehiscence) were reported, which tend to be higher when using cross-linked collagen membranes.
Topics: Humans; Alveolar Ridge Augmentation; Biocompatible Materials; Bone Regeneration; Dental Implantation, Endosseous; Dental Implants; Guided Tissue Regeneration, Periodontal; Network Meta-Analysis
PubMed: 37752820
DOI: 10.1111/prd.12531