-
The Cochrane Database of Systematic... Nov 2020Systemic antimicrobials can be used as an adjunct to mechanical debridement (scaling and root planing (SRP)) as a non-surgical treatment approach to manage... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Systemic antimicrobials can be used as an adjunct to mechanical debridement (scaling and root planing (SRP)) as a non-surgical treatment approach to manage periodontitis. A range of antibiotics with different dosage and combinations are documented in the literature. The review follows the previous classification of periodontitis as all included studies used this classification.
OBJECTIVES
To assess the effects of systemic antimicrobials as an adjunct to SRP for the non-surgical treatment of patients with periodontitis.
SEARCH METHODS
Cochrane Oral Health's Information Specialist searched the following databases to 9 March 2020: Cochrane Oral Health's Trials Register, CENTRAL, MEDLINE, and Embase. The US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) which involved individuals with clinically diagnosed untreated periodontitis. Trials compared SRP with systemic antibiotics versus SRP alone/placebo, or with other systemic antibiotics.
DATA COLLECTION AND ANALYSIS
We selected trials, extracted data, and assessed risk of bias in duplicate. We estimated mean differences (MDs) for continuous data, with 95% confidence intervals (CIs). We assessed the certainty of the evidence using GRADE.
MAIN RESULTS
We included 45 trials conducted worldwide involving 2664 adult participants. 14 studies were at low, 8 at high, and the remaining 23 at unclear overall risk of bias. Seven trials did not contribute data to the analysis. We assessed the certainty of the evidence for the 10 comparisons which reported long-term follow-up (≥ 1 year). None of the studies reported data on antimicrobial resistance and patient-reported quality of life changes. Amoxicillin + metronidazole + SRP versus SRP in chronic/aggressive periodontitis: the evidence for percentage of closed pockets (MD -16.20%, 95% CI -25.87 to -6.53; 1 study, 44 participants); clinical attachment level (CAL) (MD -0.47 mm, 95% CI -0.90 to -0.05; 2 studies, 389 participants); probing pocket depth (PD) (MD -0.30 mm, 95% CI -0.42 to -0.18; 2 studies, 389 participants); and percentage of bleeding on probing (BOP) (MD -8.06%, 95% CI -14.26 to -1.85; 2 studies, 389 participants) was of very low certainty. Only the results for closed pockets and BOP showed a minimally important clinical difference (MICD) favouring amoxicillin + metronidazole + SRP. Metronidazole + SRP versus SRP in chronic/aggressive periodontitis: the evidence for percentage of closed pockets (MD -12.20%, 95% CI -29.23 to 4.83; 1 study, 22 participants); CAL (MD -1.12 mm, 95% CI -2.24 to 0; 3 studies, 71 participants); PD (MD -1.11 mm, 95% CI -2.84 to 0.61; 2 studies, 47 participants); and percentage of BOP (MD -6.90%, 95% CI -22.10 to 8.30; 1 study, 22 participants) was of very low certainty. Only the results for CAL and PD showed an MICD favouring the MTZ + SRP group. Azithromycin + SRP versus SRP for chronic/aggressive periodontitis: we found no evidence of a difference in percentage of closed pockets (MD 2.50%, 95% CI -10.19 to 15.19; 1 study, 40 participants); CAL (MD -0.59 mm, 95% CI -1.27 to 0.08; 2 studies, 110 participants); PD (MD -0.77 mm, 95% CI -2.33 to 0.79; 2 studies, 110 participants); and percentage of BOP (MD -1.28%, 95% CI -4.32 to 1.76; 2 studies, 110 participants) (very low-certainty evidence for all outcomes). Amoxicillin + clavulanate + SRP versus SRP for chronic periodontitis: the evidence from 1 study, 21 participants for CAL (MD 0.10 mm, 95% CI -0.51 to 0.71); PD (MD 0.10 mm, 95% CI -0.17 to 0.37); and BOP (MD 0%, 95% CI -0.09 to 0.09) was of very low certainty and did not show a difference between the groups. Doxycycline + SRP versus SRP in aggressive periodontitis: the evidence from 1 study, 22 participants for CAL (MD -0.80 mm, 95% CI -1.49 to -0.11); and PD (MD -1.00 mm, 95% CI -1.78 to -0.22) was of very low certainty, with the doxycycline + SRP group showing an MICD in PD only. Tetracycline + SRP versus SRP for aggressive periodontitis: we found very low-certainty evidence of a difference in long-term improvement in CAL for the tetracycline group (MD -2.30 mm, 95% CI -2.50 to -2.10; 1 study, 26 participants). Clindamycin + SRP versus SRP in aggressive periodontitis: we found very low-certainty evidence from 1 study, 21 participants of a difference in long-term improvement in CAL (MD -1.70 mm, 95% CI -2.40 to -1.00); and PD (MD -1.80 mm, 95% CI -2.47 to -1.13) favouring clindamycin + SRP. Doxycycline + SRP versus metronidazole + SRP for aggressive periodontitis: there was very low-certainty evidence from 1 study, 27 participants of a difference in long-term CAL (MD 1.10 mm, 95% CI 0.36 to 1.84); and PD (MD 1.00 mm, 95% CI 0.30 to 1.70) favouring metronidazole + SRP. Clindamycin + SRP versus metronidazole + SRP for aggressive periodontitis: the evidence from 1 study, 26 participants for CAL (MD 0.20 mm, 95% CI -0.55 to 0.95); and PD (MD 0.20 mm, 95% CI -0.38 to 0.78) was of very low certainty and did not show a difference between the groups. Clindamycin + SRP versus doxycycline + SRP for aggressive periodontitis: the evidence from 1 study, 23 participants for CAL (MD -0.90 mm, 95% CI -1.62 to -0.18); and PD (MD -0.80 mm, 95% CI -1.58 to -0.02) was of very low certainty and did not show a difference between the groups. Most trials testing amoxicillin, metronidazole, and azithromycin reported adverse events such as nausea, vomiting, diarrhoea, mild gastrointestinal disturbances, and metallic taste. No serious adverse events were reported.
AUTHORS' CONCLUSIONS
There is very low-certainty evidence (for long-term follow-up) to inform clinicians and patients if adjunctive systemic antimicrobials are of any help for the non-surgical treatment of periodontitis. There is insufficient evidence to decide whether some antibiotics are better than others when used alongside SRP. None of the trials reported serious adverse events but patients should be made aware of the common adverse events related to these drugs. Well-planned RCTs need to be conducted clearly defining the minimally important clinical difference for the outcomes closed pockets, CAL, PD, and BOP.
Topics: Adult; Aggressive Periodontitis; Anti-Bacterial Agents; Bias; Chemotherapy, Adjuvant; Chronic Periodontitis; Confidence Intervals; Dental Prophylaxis; Humans; Randomized Controlled Trials as Topic
PubMed: 33197289
DOI: 10.1002/14651858.CD012568.pub2 -
BMJ Clinical Evidence Apr 2011Unrelieved pressure or friction of the skin, particularly over bony prominences, can lead to pressure ulcers in up to one third of people in hospitals or community care,... (Review)
Review
INTRODUCTION
Unrelieved pressure or friction of the skin, particularly over bony prominences, can lead to pressure ulcers in up to one third of people in hospitals or community care, and one fifth of nursing home residents. Pressure ulcers are more likely in people with reduced mobility and poor skin condition, such as older people or those with vascular disease.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of preventive interventions in people at risk of developing pressure ulcers? What are the effects of treatments in people with pressure ulcers? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 64 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: air-filled vinyl boots, air-fluidised supports, alternating-pressure surfaces (including mattresses), alternative foam mattresses, constant low-pressure supports, debridement, electric profiling beds, electrotherapy, hydrocellular heel supports, low-air-loss beds (including hydrotherapy beds), low-level laser therapy, low-tech constant-low-pressure supports, medical sheepskin overlays, nutritional supplements, orthopaedic wool padding, pressure-relieving overlays on operating tables, pressure-relieving surfaces, repositioning (regular "turning"), seat cushions, standard beds, standard care, standard foam mattresses, standard tables, surgery, therapeutic ultrasound, topical lotions and dressings, topical negative pressure, and topical phenytoin.
Topics: Anticonvulsants; Bandages; Bedding and Linens; Beds; Debridement; Humans; Low-Level Light Therapy; Negative-Pressure Wound Therapy; Patient Positioning; Phenytoin; Pressure Ulcer; Standard of Care; Ultrasonic Therapy
PubMed: 21524319
DOI: No ID Found -
Journal of Vascular Surgery Feb 2016Several methods of débridement of diabetic foot ulcers are currently used. The relative efficacy of these methods is not well established. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Several methods of débridement of diabetic foot ulcers are currently used. The relative efficacy of these methods is not well established.
METHODS
This systematic review and meta-analysis was conducted to find the best available evidence for the effect of débridement on diabetic foot wound outcomes. We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Web of Science, and Scopus through October 2011 for randomized controlled studies (RCTs) and observational comparative studies.
RESULTS
We identified 11 RCTs and three nonrandomized studies reporting on 800 patients. The risk of bias was moderate overall. Meta-analysis of three RCTs showed that autolytic débridement significantly increased the healing rate (relative risk [RR], 1.89; 95% confidence interval [CI] 1.35-2.64). Meta-analysis of four studies (one RCT) showed that larval débridement reduced amputation (RR, 0.43; 95% CI, 0.21-0.88) but did not increase complete healing (RR, 1.27; 95% CI, 0.84-1.91). Surgical débridement was associated with shorter healing time compared with conventional wound care (one RCT). Insufficient evidence was found for comparisons between autolytic and larval débridement (one RCT), between ultrasound-guided and surgical débridement, and between hydrosurgical and surgical débridement.
CONCLUSIONS
The available literature supports the efficacy of several débridement methods, including surgical, autolytic, and larval débridement. Comparative effectiveness evidence between these methods and supportive evidence for other methods is of low quality due to methodologic limitations and imprecision. Hence, the choice of débridement method at the present time should be based on the available expertise, patient preferences, the clinical context and cost.
Topics: Adult; Aged; Debridement; Diabetic Foot; Female; Humans; Male; Middle Aged; Treatment Outcome
PubMed: 26804366
DOI: 10.1016/j.jvs.2015.10.002 -
BMJ Clinical Evidence Aug 2011Fungal infections are reported to cause 23% of foot diseases and 50% of nail conditions in people seen by dermatologists, but are less common in the general population,... (Review)
Review
INTRODUCTION
Fungal infections are reported to cause 23% of foot diseases and 50% of nail conditions in people seen by dermatologists, but are less common in the general population, affecting 3% to 5% of people.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of oral treatments for fungal toenail infections? What are the effects of topical treatments for fungal toenail infections? We searched: Medline, Embase, The Cochrane Library, and other important databases up to March 2011 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 12 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: amorolfine, butenafine, ciclopirox, fluconazole, griseofulvin, itraconazole, ketoconazole, mechanical debridement, terbinafine, and tioconazole.
Topics: Administration, Oral; Administration, Topical; Debridement; Humans; Itraconazole; Nails; Onychomycosis
PubMed: 21846413
DOI: No ID Found -
BMJ Clinical Evidence Jul 2010Mammalian bites are usually caused by dogs, cats, or humans, and are more prevalent in children (especially boys) than in adults. Animal bites are usually caused by the... (Review)
Review
INTRODUCTION
Mammalian bites are usually caused by dogs, cats, or humans, and are more prevalent in children (especially boys) than in adults. Animal bites are usually caused by the person's pet and, in children, frequently involve the face. Human bites tend to occur in children as a result of playing or fighting, while in adults they are usually the result of physical or sexual abuse. Mixed aerobe and anaerobe infection is the most common type of infection, and can occur in up to half of human bites.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of interventions to prevent complications of mammalian bites? What are the effects of treatments for infected mammalian bites? We searched: Medline, Embase, The Cochrane Library, and other important databases up to October 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found five systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: antibiotic prophylaxis (human bites, non-human bites), antibiotics, debridement, decontamination, irrigation, primary wound closure, and tetanus vaccination (after mammalian bites).
Topics: Animals; Anti-Bacterial Agents; Antibiotic Prophylaxis; Bites and Stings; Bites, Human; Debridement; Evidence-Based Medicine; Humans; Incidence
PubMed: 21418668
DOI: No ID Found -
Hand (New York, N.Y.) Mar 2017Literature on open fracture infections has focused primarily on long bones, with limited guidelines available for open hand fractures. In this study, we systematically... (Meta-Analysis)
Meta-Analysis Review
Literature on open fracture infections has focused primarily on long bones, with limited guidelines available for open hand fractures. In this study, we systematically review the available hand surgery literature to determine infection rates and the effect of debridement timing and antibiotic administration. Searches of the MEDLINE, EMBASE, and Cochrane computerized literature databases and manual bibliography searches were performed. Descriptive/quantitative data were extracted, and a meta-analysis of different patient cohorts and treatment modalities was performed to compare infection rates. The initial search yielded 61 references. Twelve articles (4 prospective, 8 retrospective) on open hand fractures were included (1669 open fractures). There were 77 total infections (4.6%): 61 (4.4%) of 1391 patients received preoperative antibiotics and 16 (9.4%) of 171 patients did not receive antibiotics. In 7 studies (1106 open fractures), superficial infections (requiring oral antibiotics only) accounted for 86%, whereas deep infections (requiring operative debridement) accounted for 14%. Debridement within 6 hours of injury (2 studies, 188 fractures) resulted in a 4.2% infection rate, whereas debridement within 12 hours of injury (1 study, 193 fractures) resulted in a 3.6% infection rate. Two studies found no correlation of infection and timing to debridement. Overall, the infection rate after open hand fracture remains relatively low. Correlation does exist between the administration of antibiotics and infection, but the majority of infections can be treated with antibiotics alone. Timing of debridement, has not been shown to alter infection rates.
Topics: Anti-Bacterial Agents; Debridement; Drug Administration Schedule; Fractures, Open; Hand Injuries; Humans; Surgical Wound Infection; Time Factors
PubMed: 28344521
DOI: 10.1177/1558944716643294 -
International Wound Journal Dec 2017Enzymatic debridement with collagenase is a technique that is commonly used in clinical practice. This systematic review examines the effect of collagenase on all kinds... (Meta-Analysis)
Meta-Analysis Review
Enzymatic debridement with collagenase is a technique that is commonly used in clinical practice. This systematic review examines the effect of collagenase on all kinds of wounds, compared to an alternative therapy, on wound healing, wound bed characteristics, cost-effectiveness and the occurrence of adverse events. We conducted a systematic literature search on available literature in Cochrane databases, MEDLINE, EMBASE and CINAHL. Two investigators independently assessed the titles and abstracts of all randomised controlled trials obtained involving collagenase of all kinds of wounds based on inclusion criteria. Of the 1411 citations retrieved, 22 studies reported outcomes with the use of collagenase either for wound healing or wound debridement. Results support the use of collagenase for enzymatic debridement in pressure ulcers, diabetic foot ulcers and in conjunction with topical antibiotics for burns. However, studies presented a high risk of bias. Risk ratio of developing an adverse event related to collagenase versus the alternative treatment was statistically significant (for 10 studies, RR: 1·79, 95% CI 1·24-2·59, I =0%, P = 0·002). There is very limited data on the effect of collagenase as an enzymatic debridement technique on wounds. More independant research and adequate reporting of adverse events are warranted.
Topics: Burns; Collagenases; Debridement; Humans; Skin Ulcer; Wound Healing
PubMed: 28440050
DOI: 10.1111/iwj.12760 -
BMJ Clinical Evidence Oct 2014Raynaud's phenomenon is episodic vasospasm of the peripheral vessels. It presents as episodic colour changes of the digits (sometimes accompanied by pain and... (Review)
Review
INTRODUCTION
Raynaud's phenomenon is episodic vasospasm of the peripheral vessels. It presents as episodic colour changes of the digits (sometimes accompanied by pain and paraesthesia), usually in response to cold exposure or stress. The classic triphasic colour change is white (ischaemia), then blue (de-oxygenation), then red (reperfusion). Raynaud's phenomenon can be primary (idiopathic) or secondary to several different conditions and causes. When secondary (e.g., to systemic sclerosis), it can progress to ulceration of the fingers and toes. This review deals with secondary Raynaud's phenomenon.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of surgical interventions in complicated secondary Raynaud's phenomenon? We searched: Medline, Embase, The Cochrane Library, and other important databases up to March 2014 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found two studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: botulinum toxin, simple debridement/surgical toilet of ulcers, peripheral sympathectomy (digital, digital plus sympathectomy of the ulnar and/or radial artery, ligation of the ulnar artery), cervical/thoracic sympathectomy, arterial reconstruction (venous graft, arterial graft, balloon angioplasty), and amputation.
Topics: Amputation, Surgical; Botulinum Toxins; Debridement; Humans; Peripheral Nerves; Raynaud Disease; Sympathectomy; Ulcer
PubMed: 25322727
DOI: No ID Found -
BMJ Clinical Evidence Mar 2008Unrelieved pressure or friction of the skin, particularly over bony prominences, can lead to pressure ulcers in up to a third of people in hospitals or community care,... (Review)
Review
INTRODUCTION
Unrelieved pressure or friction of the skin, particularly over bony prominences, can lead to pressure ulcers in up to a third of people in hospitals or community care, and a fifth of nursing home residents. Pressure ulcers are more likely in people with reduced mobility and poor skin condition, such as older people or those with vascular disease.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of preventive interventions in people at risk of developing pressure ulcers? What are the effects of treatments in people with pressure ulcers? We searched: Medline, Embase, The Cochrane Library and other important databases up to February 2007 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 60 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: air-filled vinyl boots, air-fluidised supports, alternating pressure surfaces (including mattresses), alternative foam mattresses, constant low-pressure supports, debridement, electric profiling beds, electrotherapy, hydrocellular heel supports, low-air-loss beds (including hydrotherapy beds), low-level laser therapy, low-tech constant low-pressure supports, medical sheepskin overlays, nutritional supplements, orthopaedic wool padding, pressure-relieving overlays on operating tables, pressure-relieving surfaces, repositioning (regular "turning"), seat cushions, standard beds, standard care, standard foam mattresses, standard tables, surgery, therapeutic ultrasound, topical lotions and dressings, topical negative pressure, and topical phenytoin.
Topics: Animals; Bandages; Beds; Humans; Low-Level Light Therapy; Negative-Pressure Wound Therapy; Phenytoin; Pressure Ulcer
PubMed: 19450317
DOI: No ID Found -
The Cochrane Database of Systematic... Oct 2018Foot wounds in people with diabetes mellitus (DM) are a common and serious global health issue. People with DM are prone to developing foot ulcers and, if these do not... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Foot wounds in people with diabetes mellitus (DM) are a common and serious global health issue. People with DM are prone to developing foot ulcers and, if these do not heal, they may also undergo foot amputation surgery resulting in postoperative wounds. Negative pressure wound therapy (NPWT) is a technology that is currently used widely in wound care. NPWT involves the application of a wound dressing attached to a vacuum suction machine. A carefully controlled negative pressure (or vacuum) sucks wound and tissue fluid away from the treated area into a canister. A clear and current overview of current evidence is required to facilitate decision-making regarding its use.
OBJECTIVES
To assess the effects of negative pressure wound therapy compared with standard care or other therapies in the treatment of foot wounds in people with DM in any care setting.
SEARCH METHODS
In January 2018, for this first update of this review, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies, reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. We identified six additional studies for inclusion in the review.
SELECTION CRITERIA
Published or unpublished randomised controlled trials (RCTs) that evaluated the effects of any brand of NPWT in the treatment of foot wounds in people with DM, irrespective of date or language of publication. Particular effort was made to identify unpublished studies.
DATA COLLECTION AND ANALYSIS
Two review authors independently performed study selection, risk of bias assessment and data extraction. Initial disagreements were resolved by discussion, or by including a third review author when necessary. We presented and analysed data separately for foot ulcers and postoperative wounds.
MAIN RESULTS
Eleven RCTs (972 participants) met the inclusion criteria. Study sample sizes ranged from 15 to 341 participants. One study had three arms, which were all included in the review. The remaining 10 studies had two arms. Two studies focused on postamputation wounds and all other studies included foot ulcers in people with DM. Ten studies compared NPWT with dressings; and one study compared NPWT delivered at 75 mmHg with NPWT delivered at 125 mmHg. Our primary outcome measures were the number of wounds healed and time to wound healing.NPWT compared with dressings for postoperative woundsTwo studies (292 participants) compared NPWT with moist wound dressings in postoperative wounds (postamputation wounds). Only one study specified a follow-up time, which was 16 weeks. This study (162 participants) reported an increased number of healed wounds in the NPWT group compared with the dressings group (risk ratio (RR) 1.44, 95% confidence interval (CI) 1.03 to 2.01; low-certainty evidence, downgraded for risk of bias and imprecision). This study also reported that median time to healing was 21 days shorter with NPWT compared with moist dressings (hazard ratio (HR) calculated by review authors 1.91, 95% CI 1.21 to 2.99; low-certainty evidence, downgraded for risk of bias and imprecision). Data from the two studies suggest that it is uncertain whether there is a difference between groups in amputation risk (RR 0.38, 95% CI 0.14 to 1.02; 292 participants; very low-certainty evidence, downgraded once for risk of bias and twice for imprecision).NPWT compared with dressings for foot ulcersThere were eight studies (640 participants) in this analysis and follow-up times varied between studies. Six studies (513 participants) reported the proportion of wounds healed and data could be pooled for five studies. Pooled data (486 participants) suggest that NPWT may increase the number of healed wounds compared with dressings (RR 1.40, 95% CI 1.14 to 1.72; I² = 0%; low-certainty evidence, downgraded once for risk of bias and once for imprecision). Three studies assessed time to healing, but only one study reported usable data. This study reported that NPWT reduced the time to healing compared with dressings (hazard ratio (HR) calculated by review authors 1.82, 95% CI 1.27 to 2.60; 341 participants; low-certainty evidence, downgraded once for risk of bias and once for imprecision).Data from three studies (441 participants) suggest that people allocated to NPWT may be at reduced risk of amputation compared with people allocated to dressings (RR 0.33, 95% CI 0.15 to 0.70; I² = 0%; low-certainty evidence; downgraded once for risk of bias and once for imprecision).Low-pressure compared with high-pressure NPWT for foot ulcersOne study (40 participants) compared NPWT 75 mmHg and NPWT 125 mmHg. Follow-up time was four weeks. There were no data on primary outcomes. There was no clear difference in the number of wounds closed or covered with surgery between groups (RR 0.83, 95% CI 0.47 to 1.47; very low-certainty evidence, downgraded once for risk of bias and twice for serious imprecision) and adverse events (RR 1.50, 95% CI 0.28 to 8.04; very low-certainty evidence, downgraded once for risk of bias and twice for serious imprecision).
AUTHORS' CONCLUSIONS
There is low-certainty evidence to suggest that NPWT, when compared with wound dressings, may increase the proportion of wounds healed and reduce the time to healing for postoperative foot wounds and ulcers of the foot in people with DM. For the comparisons of different pressures of NPWT for treating foot ulcers in people with DM, it is uncertain whether there is a difference in the number of wounds closed or covered with surgery, and adverse events. None of the included studies provided evidence on time to closure or coverage surgery, health-related quality of life or cost-effectiveness. The limitations in current RCT evidence suggest that further trials are required to reduce uncertainty around decision-making regarding the use of NPWT to treat foot wounds in people with DM.
Topics: Amputation, Surgical; Bandages; Debridement; Diabetic Foot; Humans; Negative-Pressure Wound Therapy; Randomized Controlled Trials as Topic; Wound Healing
PubMed: 30328611
DOI: 10.1002/14651858.CD010318.pub3