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Acta Otorhinolaryngologica Italica :... Aug 2019
Meta-Analysis
Topics: Adult; Cautery; Databases, Factual; Drug Combinations; Electrocoagulation; Embolism; Endoscopy; Endovascular Procedures; Epistaxis; Gelatin Sponge, Absorbable; Humans; Laser Therapy; Silver Nitrate; Tranexamic Acid
PubMed: 30933179
DOI: 10.14639/0392-100X-2155 -
The Journal of Bone and Joint Surgery.... Dec 2018Chronic osteomyelitis is caused by bacterial infection of the bone and is a major problem in orthopaedic surgery. Treatment of chronic osteomyelitis requires surgical... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Chronic osteomyelitis is caused by bacterial infection of the bone and is a major problem in orthopaedic surgery. Treatment of chronic osteomyelitis requires surgical debridement accompanied by local and systemic administration of antibiotics. A widely established biodegradable local antibiotic carrier is antibiotic-loaded collagen sponges (fleeces). These sponges are commonly used in the treatment of chronic osteomyelitis, but a systematic review of their clinical efficacy and assessment of the quality of evidence have not been conducted, to our knowledge.
METHODS
This systematic review, performed according to the PRISMA statement, examined the clinical efficacy of and quality of evidence regarding different antibiotic-loaded collagen sponges in the clinical treatment of chronic osteomyelitis. Clinical efficacy was defined as eradication of infection with bone and wound-healing. In addition, the in vivo pharmacokinetics of the various collagen sponges were evaluated. Quality was based on the Level of Evidence, methodological quality, and risks of bias.
RESULTS
A total of 813 articles were screened, and 10 were included. Gentamicin-sulfate sponges and gentamicin-sulfate/gentamicin-crobefate sponges were studied. A total of 413 patients were treated, with a success rate of 91%. Reported complications were fistulas, prolonged wound drainage, and wound-healing problems. In vivo pharmacokinetic profiles showed an average local antibiotic concentration that was above the minimum inhibitory concentration for only 5 days. The general quality of the included studies was low to moderate, and there was a moderate to high risk of bias.
CONCLUSIONS
The evidence quality and Level of Evidence of the included studies were low, and the risk of bias in these studies was high. This makes the evidence regarding these sponges inconclusive, and no clinical decision-making can be based on these studies. Utilization of antibiotic-loaded collagen sponges in the treatment of chronic osteomyelitis should only be carried out with caution; studies with high-level evidence are needed.
LEVEL OF EVIDENCE
Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
Topics: Absorbable Implants; Adult; Anti-Bacterial Agents; Chronic Disease; Collagen; Female; Gentamicins; Humans; Male; Middle Aged; Osteomyelitis; Research Design; Surgical Sponges; Treatment Outcome
PubMed: 30562296
DOI: 10.2106/JBJS.17.01140 -
The Bone & Joint Journal Nov 2018Local antibiotics are used in the surgical management of foot infection in diabetic patients. This systematic review analyzes the available evidence of the use of local... (Review)
Review
AIMS
Local antibiotics are used in the surgical management of foot infection in diabetic patients. This systematic review analyzes the available evidence of the use of local antibiotic delivery systems as an adjunct to surgery.
MATERIALS AND METHODS
Databases were searched to identify eligible studies and 13 were identified for inclusion.
RESULTS
Overall, the quality of the studies was poor. A single trial suggested that wound healing is quicker when a gentamicin-impregnated collagen sponge was implanted at time of surgery, with no difference in length of stay or rate of amputation. Results from studies with high risk of bias indicated no change in wound healing when a gentamicin-impregnated sponge was implanted during transmetatarsal amputation, but a reduction in the incidence of wound breakdown (8% vs 25%, not statistically significant) was identified. A significant cost reduction was identified when using an antimicrobial gel to deliver antibiotics and anti-biofilm agents (quorum-sensing inhibitors) compared with routine dressings and systemic antibiotics. Analyses of case series identified 485 patients who were treated using local antibiotic delivery devices. The rates of wound healing, re-operation, and mortality were comparable to those that have been previously reported for the routine management of these infections.
CONCLUSION
There is a lack of good-quality evidence to support the use of local antibiotic delivery devices in the treatment of foot infections in patients with diabetes. Cite this article: Bone Joint J 2018;100-B:1409-15.
Topics: Administration, Topical; Anti-Bacterial Agents; Bacterial Infections; Combined Modality Therapy; Diabetic Foot; Humans; Reoperation; Wound Healing
PubMed: 30418057
DOI: 10.1302/0301-620X.100B11.BJJ-2018-0720 -
Acta Neurochirurgica Nov 2018Various synthetic materials are used in neurosurgery and left in place intentionally during surgery for several purposes such as hemostasis, dural closure, or...
BACKGROUND
Various synthetic materials are used in neurosurgery and left in place intentionally during surgery for several purposes such as hemostasis, dural closure, or cranioplasty. Although leaving such substances in surgical sites is considered safe, in general, foreign body granuloma may occur months or years after intracranial surgery. Thus, far relatively little is known about treatment and outcome of such lesions.
METHODS
A systematic review of 3466 histopathological examinations after cranial surgeries achieved over a 13-year period was performed. After excluding patients with Teflon granulomas or infection, a total of 12 patients with foreign body granulomas induced by synthetic material used in a prior surgery were identified. Patient records, imaging studies, and histopathological data were analyzed. Furthermore, postoperative outcome was assessed.
RESULTS
Mean age at the second surgery was 51 years (range, 11-68 years). The median time between the primary and the secondary surgery was 13 months (range, 1-545 months). Eight patients (75%) presented with signs and symptoms related to the foreign body granulomas. Total resection of the foreign body granulomas was performed in all patients. The granulomas were induced by oxidized cellulose polymer (n = 6), suture material (n = 3), Gelfoam (n = 1), methylmethacrylate (n = 1), and bone wax (n = 1). The mean postoperative follow-up time was 54 months (range 1-137 months). There was symptomatic improvement in all instances. Imaging studies did not demonstrate any recurrence.
CONCLUSION
Despite its rarity, foreign body granuloma should be taken into consideration in the differential diagnosis of intracranial mass lesions especially in cases of suspected tumor recurrence after prior surgery. The pathogenesis of foreign body granuloma still needs further clarification. Our study demonstrates that they have good prognosis after surgical removal.
Topics: Adolescent; Adult; Aged; Brain; Child; Diagnosis, Differential; Female; Gelatin Sponge, Absorbable; Granuloma, Foreign-Body; Humans; Male; Middle Aged; Neurosurgical Procedures; Postoperative Complications; Sutures
PubMed: 30187219
DOI: 10.1007/s00701-018-3663-0 -
The Cochrane Database of Systematic... Aug 2018During elective (planned) caesarean sections, some obstetricians routinely dilate the cervix intraoperatively, using sponge forceps, a finger, or other instruments,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
During elective (planned) caesarean sections, some obstetricians routinely dilate the cervix intraoperatively, using sponge forceps, a finger, or other instruments, because the cervix of women not in labour may not be dilated, and this may cause obstruction of blood or lochia drainage. However, mechanical cervical dilatation during caesarean section may result in contamination by vaginal micro-organisms during dilatation, and increase the risk of infection or cervical trauma.
OBJECTIVES
To determine the effects of mechanical dilatation of the cervix during elective caesarean section on postoperative morbidity.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) and reference lists of retrieved studies on 20 September 2017.
SELECTION CRITERIA
We included all randomised, quasi-randomised, and cluster-randomised controlled trials comparing intraoperative cervical dilatation using a finger, sponge forceps, or other instruments during elective caesarean section versus no mechanical dilatation.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the quality of the evidence using the GRADE approach.
MAIN RESULTS
We included eight studies with a total of 2227 women undergoing elective caesarean section. Of these, 1097 underwent intraoperative cervical dilatation with a double-gloved index finger or Hegar dilator inserted into the cervical canal to dilate, and 1130 did not undergo intraoperative cervical dilatation. Six of the eight included trials had high risk of bias for some of the risk of bias domains.Very low-quality evidence suggested it was unclear whether cervical dilatation had any impact on postpartum haemorrhage (estimated blood loss greater than 1000 mL; risk ratio (RR) 1.97, 95% confidence interval (CI) 0.48 to 8.13; 5/205 versus 3/242; one study, 447 women).Low- or very low-quality evidence showed no clear difference for the need for blood transfusion (RR 3.54, 95% CI 0.37 to 33.79; two studies, 847 women); postoperative haemoglobin (mean difference (MD -0.05, 95% CI -0.15 to 0.06; three studies, 749 women), or haematocrit (MD 0.01%, 95% CI -0.18 to 0.20; one study, 400 women); the incidence of drop from baseline haemoglobin above 0.5 g/dL (RR 0.92, 95% CI 0.64 to 1.31; two studies, 722 women), or amount of haemoglobin drop (MD -0.01 g/dL, 95% -0.14 to 0.13; three studies, 796 women); the incidence of secondary postpartum haemorrhage within six weeks (RR 1.18, 95% CI 0.07 to 18.76; one study, 447 women); febrile morbidity (RR 1.18, 95% CI 0.76 to 1.85; seven studies, 2126 women); endometritis (RR 0.94, 95% CI 0.35 to 2.52; four studies, 1536 women); or uterine subinvolution (RR 0.34, 95% CI 0.08 to 1.36; two studies, 654 women); the results crossed the line of no effect for all of the outcomes. There were no data for cervical trauma.We found a slight improvement with mechanical dilatation for these secondary outcomes, not prespecified in the protocol: mean blood loss, endometrial cavity thickness, retained products of conception, distortion of uterine incision, and healing ratio. The evidence for these outcomes was based on one or two studies. Cervical dilatation did not have a clear effect on these secondary outcomes, not prespecified in the protocol: wound infection, urinary tract infection, operative time, infectious morbidity, and integrity of uterine scar.
AUTHORS' CONCLUSIONS
At this time, the evidence does not support or refute the use of mechanical dilatation of the cervix during elective caesarean section for reducing postoperative morbidity.Further large, well-designed studies are required to compare the effect of intraoperative mechanical dilatation of the cervix with no intraoperative mechanical cervical dilatation for reducing postoperative morbidity.
Topics: Cervix Uteri; Cesarean Section; Dilatation; Elective Surgical Procedures; Endometritis; Female; Humans; Labor Stage, First; Postoperative Complications; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic; Surgical Wound Infection; Urinary Tract Infections
PubMed: 30096215
DOI: 10.1002/14651858.CD008019.pub3 -
European Journal of Gastroenterology &... Nov 2018Esophageal adenocarcinoma is an increasingly common cause of morbidity and mortality in developed countries. Most cases are considered the consequence of chronic... (Meta-Analysis)
Meta-Analysis
Esophageal adenocarcinoma is an increasingly common cause of morbidity and mortality in developed countries. Most cases are considered the consequence of chronic gastroesophageal reflux disease, with subsequent Barrett's metaplasia and dysplasia. Because progression from Barrett's metaplasia to cancer occurs over many years, endoscopic screening and surveillance programs have been established, albeit with little or no consideration for cost-effectiveness. As an alternative to the expensive and resource-demanding endoscopic surveillance, the Cytosponge has been developed to sample the esophageal mucosa efficiently. The device is a compressed mesh sponge encapsulated in an ingestible gelatin pill attached to a string. After swallowing, the capsule dissolves allowing the sponge to expand in the stomach. As it is pulled out, cells are collected from the esophagogastric junction and throughout the esophagus. The cellular samples can be analyzed by cytology, immunohistochemistry, and molecular markers. We conducted a systematic review of all recent relevant studies to help define the role of this novel technology, including studies of screening and surveillance of Barrett's esophagus, esophageal squamous dysplasia detection, detection of eosinophilic esophagitis, and evaluation of benign esophageal diseases. With the major limitation that most studies were performed by a single investigative group that developed the technology, the device yielded overall impressive results against the endoscopy/biopsy gold standard. Patient acceptability was high. If these promising early results are validated by other investigators in other populations, the Cytosponge represents an important new advance in the detection of esophageal pathology that could potentially decrease the burden of endoscopic esophageal sampling.
Topics: Adenocarcinoma; Adult; Aged; Barrett Esophagus; Cytodiagnosis; Equipment Design; Esophageal Mucosa; Esophageal Neoplasms; Female; Humans; Male; Middle Aged; Precancerous Conditions; Predictive Value of Tests; Specimen Handling; Surgical Sponges; Young Adult
PubMed: 30044236
DOI: 10.1097/MEG.0000000000001210 -
The Journal of Laryngology and Otology Jun 2018A systematic review was conducted to investigate the effectiveness of fibroblast growth factor-2 on the regeneration of tympanic membrane perforation. (Review)
Review
OBJECTIVE
A systematic review was conducted to investigate the effectiveness of fibroblast growth factor-2 on the regeneration of tympanic membrane perforation.
METHODS
The PubMed database was searched for relevant studies. Experimental studies, human randomised controlled trials, prospective single-arm studies and retrospective studies reporting acute and chronic tympanic membrane perforations in relation to two healing outcomes (success rate and closure time), were selected.
RESULTS
All 11 clinical studies investigating the effect of fibroblast growth factor-2 on traumatic tympanic membrane perforations in humans reported a success rate of 89.3-100 per cent, with a closure time of around 2 weeks. Three studies of fibroblast growth factor-2 combined with Gelfoam showed that the success rate of chronic tympanic membrane perforation was 83-98.1 per cent in the fibroblast growth factor-2 group, but 10 per cent in the gelatine sponge groups.
CONCLUSION
Fibroblast growth factor-2 with or without biological material patching promotes regeneration in cases of acute and chronic tympanic membrane perforation, and is safe and efficient. However, the best dosage, application time and administration pathway of fibroblast growth factor-2 are still to be elucidated.
Topics: Chronic Disease; Fibroblast Growth Factor 2; Gelatin Sponge, Absorbable; Hemostatics; Humans; Regeneration; Treatment Outcome; Tympanic Membrane; Tympanic Membrane Perforation
PubMed: 30019671
DOI: 10.1017/S002221511800083X -
Techniques in Coloproctology Aug 2018Among the techniques investigated to reduce the risk of surgical wound infection or surgical space infection (SSI) in patients having colorectal surgery are topical... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Among the techniques investigated to reduce the risk of surgical wound infection or surgical space infection (SSI) in patients having colorectal surgery are topical application of antimicrobials (antibiotics and antiseptics) to the open wound or immediately after closure. The aim of the present study was to perform a systematic review of the literature on those treatments, with the exception of antibiotic ointments applied to closed skin, which are adequately assessed elsewhere, and a meta-analysis.
METHODS
Only randomized trials of patients having only colorectal surgery were included in this review. Studies were sought in MEDLINE, EMBASE, the Cochrane Register of Controlled Trials, Clinical Trials.gov, and the World Health Organization Internet clinical trials register portal. In addition, reference lists of included studies and other published reviews were screened. Meta-analysis was performed for all included studies and subgroup analyses done for each individual intervention. Risk of bias was assessed for each included study, paying particular attention to the preoperative antibiotic prophylaxis used in each study. Sensitivity analyses were done to investigate heterogeneity of the analyses, excluding those studies with a significant risk of bias issues. Absolute risk reduction (RR) was calculated. The overall quality of the evidence for each individual intervention was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, and was classified as high, moderate, low or very low.
RESULTS
A total of 30 studies are included in this review with 5511 patients, 665 of whom had SSI. The interventions included: 10 studies of gentamicin impregnated sponge or beads wound inlays, 4 studies of chlorhexidine impregnated suture, 11 studies of direct wound lavage or powder application or injection of antibiotics before closure, 4 studies of ionized silver dressing applied to the closed skin, and 1 study of vitamin E oil applied to the open wound. All but one study used preoperative antibiotic prophylaxis in addition to topical procedures, although, in some studies, the systemic antibiotic prophylaxis was not the same between groups or varied significantly from the recommended guidelines. Use of gentamycin sponge did not decrease SSI (RR 0.93, 95% CI 0.75-1.16; low-quality evidence) even after including only the studies of abdominal wounds (RR 1.02, 95% CI 0.80-1.30; low-quality evidence). However, sensitivity analysis excluding studies at high risk of bias decreased the heterogeneity and increased the effect of the prophylaxis for all wounds (RR 0.5, 95% CI 0.33-0.78; low-quality evidence) and for abdominal wounds only (RR 0.38, 95% CI 0.20-0.72; moderate-quality evidence). Chlorhexidine impregnated suture showed no effect on SSI (RR 0.79, 95% CI 0.56-1.10; low-quality evidence) and an increased efficacy after sensitivity analysis (RR 0.42, 95% CI 0.22-0.79; low-quality evidence). Antibiotic lavage showed a significant decrease in SSI (RR 0.45, 95% CI 0.26-0.79; low-quality evidence) which increased after sensitivity analysis (RR 0.33, 95% CI 0.15-0.72; moderate-quality evidence). Application of silver dressing to the closed wound resulted in a decrease of SSI (RR 0.55, 95% CI 0.35-0.85; moderate-quality evidence). The one study of topical vitamin E oil applied to the open wound showed a significant risk reduction (RR 0.22, 95% CI 0.05-0.98; low-quality evidence).
CONCLUSIONS
Each of these interventions appears to be effective in decreasing SSI, but the number of studies for each is small and the quality of evidence is very low to moderate. Within the various outcomes of GRADE assessment, even a moderate classification suggests that further studies may well have very different results.. No randomized trials exist of combinations of two or more of the above interventions to see if there is a combined effect. Future studies should make sure that the antibiotic used preoperatively is uniform within a study and is consistent with the current guidelines. Deviation from this leads to a significant heterogeneity and risk of bias.
Topics: Administration, Topical; Anti-Infective Agents; Anti-Infective Agents, Local; Antibiotic Prophylaxis; Colon; Digestive System Surgical Procedures; Humans; Randomized Controlled Trials as Topic; Rectum; Surgical Wound Infection; Treatment Outcome
PubMed: 30019145
DOI: 10.1007/s10151-018-1814-1 -
The Cochrane Database of Systematic... Jul 2018Cesarean delivery is one of the most common surgical procedures performed by obstetricians. Infectious morbidity after cesarean delivery can have a tremendous impact on... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cesarean delivery is one of the most common surgical procedures performed by obstetricians. Infectious morbidity after cesarean delivery can have a tremendous impact on the postpartum woman's return to normal function and her ability to care for her baby. Despite the widespread use of prophylactic antibiotics, postoperative infectious morbidity still complicates cesarean deliveries. This is an update of a Cochrane review first published in 2010 and subsequently updated in 2012, and twice in 2014.
OBJECTIVES
To determine if cleansing the vagina with an antiseptic solution before a cesarean delivery decreases the risk of maternal infectious morbidities, including endometritis and wound complications. We also assessed the side effects of vaginal cleansing solutions to determine adverse events associated with the intervention.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (10 July 2017), and reference lists of retrieved studies.
SELECTION CRITERIA
We included randomized trials and one quasi-randomized trial assessing the impact of vaginal cleansing immediately before cesarean delivery with any type of antiseptic solution versus a placebo solution/standard of care on post-cesarean infectious morbidity. Cluster-randomized trials were eligible for inclusion but none were identified. We excluded trials that utilized vaginal preparation during labor or that did not use antibiotic surgical prophylaxis. We also excluded any trials using a cross-over design.
DATA COLLECTION AND ANALYSIS
At least three of the review authors independently assessed eligibility of the studies. Two review authors were assigned to extract study characteristics, quality assessments, and data from eligible studies.
MAIN RESULTS
We included 11 trials reporting results for 3403 women evaluating the effects of vaginal cleansing (eight using povidone-iodine, two chlorhexidine, one benzalkonium chloride) on post-cesarean infectious morbidity. Additionally, some trials used vaginal preparations using sponge sticks, douches, or soaked gauze wipes. The control groups were typically no vaginal preparation (eight trials) or the use of a saline vaginal preparation (three trials). The risk of bias in the studies reduced our confidence in the results for endometritis outcomes.Vaginal preparation with antiseptic solution immediately before cesarean delivery probably reduces the incidence of post-cesarean endometritis from 8.7% in control groups to 3.8% in vaginal cleansing groups (average risk ratio (RR) 0.36, 95% confidence interval (CI) 0.20 to 0.63, 10 trials, 3283 women, moderate quality of evidence). Subgroup analysis could not rule out larger reductions in endometritis with antiseptics in women who were in labor or in women whose membranes had ruptured when antiseptics were used. Risks of postoperative fever and postoperative wound infection may be slightly lowered by antiseptic preparation, but the confidence intervals around the effects for both outcomes are consistent with a large reduction in risk and no difference between groups (fever: RR 0.87 (0.72 to 1.05; wound infection: RR 0.74 (95% CI 0.49 to 1.11), both moderate-quality evidence). Two trials reported a lower risk of a composite outcome of wound complication or endometritis in women receiving preoperative vaginal preparation (RR 0.46, 95% CI 0.26 to 0.82, two trials, 499 women, moderate-quality evidence). No adverse effects were reported with either the povidone-iodine or chlorhexidine vaginal cleansing.
AUTHORS' CONCLUSIONS
Vaginal preparation with povidone-iodine or chlorhexidine solution compared to saline or not cleansing immediately before cesarean delivery probably reduces the risk of post-cesarean endometritis. Subgroup analysis could not rule out larger reductions in endometritis with antiseptics in women who were in labor or in women whose membranes had ruptured when antiseptics were used.The quality of the evidence using GRADE was moderate for all reported outcomes. We downgraded the outcome of post-cesarean endometritis and composite of wound complications or endometritis for risk of bias and postoperative fever and postoperative wound infections for wide CIs.As a simple, generally inexpensive intervention, providers may consider implementing preoperative vaginal cleansing with povidone-iodine or chlorhexidine before performing cesarean deliveries.
Topics: Administration, Intravaginal; Anti-Infective Agents, Local; Benzalkonium Compounds; Cesarean Section; Chlorhexidine; Disinfection; Endometritis; Female; Fever; Humans; Povidone-Iodine; Pregnancy; Preoperative Care; Randomized Controlled Trials as Topic; Surgical Wound Infection; Vagina
PubMed: 30016540
DOI: 10.1002/14651858.CD007892.pub6 -
The Cochrane Database of Systematic... Jul 2018Individuals on continuous treatment with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) are at increased risk of bleeding complications during and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Individuals on continuous treatment with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) are at increased risk of bleeding complications during and after oral or dental procedures. Anticoagulant treatment is preferably continued at the same dose, since dose reduction or discontinuation of treatment is associated with an increased risk of thromboembolism. The use of haemostatic measures during or after the procedure (or both) could enable continuation of the oral anticoagulant treatment.
OBJECTIVES
We aimed to assess the efficacy of antifibrinolytic agents for preventing bleeding complications in people on oral anticoagulants undergoing minor oral surgery or dental extractions.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Coagulopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews. We searched PubMed, Embase and the Cochrane Library. Additional searches were performed using ClinicalTrials.gov, the International Clinical Trials Registry Platform (ICTRP), the CINAHL database of nursing and allied health services, the open access ProQuest dissertation database, papers and reports from the American College of Clinical Pharmacy (ACCP) and abstract books from annual scientific conferences.Date of last search: 04 January 2018.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials in people on continuous treatment with VKAs or DOACs undergoing oral or dental procedures using antifibrinolytic agents (tranexamic acid (TXA) or epsilon aminocaproic acid) to prevent perioperative bleeding compared to no intervention or usual care with or without placebo.
DATA COLLECTION AND ANALYSIS
Two authors independently screened the titles and abstracts of all identified articles. Full texts were obtained from potentially relevant abstracts and two authors independently assessed these for inclusion based of the selection criteria. A third author verified trial eligibility. Two authors independently performed data extraction and risk of bias assessments using standardized forms. The quality of the evidence was assessed using GRADE.
MAIN RESULTS
No eligible trials in people on continuous treatment with DOACs undergoing oral or dental procedures were identified.Three randomised trials and one quasi-randomised trial (follow-up in all was seven days) in people on continuous treatment with VKAs were included with a total of 253 participants (mean age 60 years). Two trials published in 1989 and 1993 compared the antifibrinolytic agent TXA with placebo in people using VKAs. Two other trials were published in 1999 and 2015 and compared TXA with gelatin sponge and sutures, and dry gauze compression, respectively. In all included trials, those who were treated with VKAs had international normalised ratio (INR) values within the therapeutic range and TXA was applied locally, not systemically.The two trials from 1989 and 1993 comparing TXA with placebo showed a statistically significant beneficial effect regarding the number of major postoperative bleeding episodes requiring intervention, with a pooled risk difference (RD) of -0.25 (95% confidence interval (CI) -0.36 to -0.14) (128 participants) (moderate-quality evidence). For the two trials that compared TXA with either gelatin sponge and sutures or with dry gauze compression, there was no difference between the TXA and the standard care group, RD 0.02 (95% CI -0.07 to 0.11) (125 participants) (moderate-quality evidence). The combined RD of all included trials was -0.13 (95% CI -0.30 to 0.05) (moderate-quality evidence). There were no side effects of antifibrinolytic therapy that required treatment withdrawal (128 participants) (moderate-quality evidence). Despite heterogeneity between trials with respect to the different haemostatic measures used in the control groups, the trials were comparable regarding design and baseline participant characteristics.Overall, we considered the risk of bias to be low in the trials comparing TXA with placebo and moderate in the trials comparing TXA with alternative haemostatic measures.
AUTHORS' CONCLUSIONS
Based on the results of this Cochrane Review, there seems to be a beneficial effect of locally applied TXA in preventing oral bleeding in people on continuous treatment with VKAs undergoing minor oral surgery or dental extractions. However, the small number of identified randomised controlled trials, the relatively small number of participants included in the trials and the differences in standard therapy and treatment regimens between trials, do not allow us to conclude definite efficacy of antifibrinolytic therapy in this population.We were unable to identify any eligible trials in people on continuous treatment with DOACs undergoing oral or dental procedures. Therefore, a beneficial effect of antifibrinolytic therapy can currently only be assumed based on data from the people using VKAs.
Topics: Anticoagulants; Antifibrinolytic Agents; Humans; Middle Aged; Minor Surgical Procedures; Oral Hemorrhage; Oral Surgical Procedures; Tooth Extraction; Tranexamic Acid
PubMed: 29963686
DOI: 10.1002/14651858.CD012293.pub2