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Sutures versus staples for wound closure in orthopaedic surgery: a pilot randomized controlled trial.

ABSTRACT: BACKGROUND:In the spectrum of surgical decision-making, wound closure material is often an afterthought. However, the findings of a recent meta-analysis suggest that the rate of surgical site infections (SSIs) is increased by using staples to close surgical wounds. Less clear is the effect of closure material on the incidence of non-infectious wound complications.The aim of this study was to compare sutures and staples in terms of: incidence of wound complications to determine the sample size for a definitive trial comparing wound closure methods. METHODS:Eligible adult orthopaedic patients were randomized to have wounds closed with sutures or staples. Time for skin closure was recorded. Wounds were assessed for complications for six weeks. The incidence of complications was compared using Fisher's exact test. Time to close and pain with removal of closure material were compared using a Student's t-test. RESULTS:The total number of patients reporting a wound complication was 59 of 148 patients completing six-week followup (41%), with no differennce between sutures and staples (RR = 0.77, CI = 0.52-1.14). The time to close wounds was shorter in the staple group (mean=4.8 min, CI = 2.6-7.1) than the suture group (mean=12 min, CI = 7.9-16). Patients in the staple group (mean=3.7, CI =2.8-4.6) reported more pain with removal than suture group (mean=2.5, CI =1.6-3.4). CONCLUSIONS:This study suggests that 42% of patients report a wound complication with no difference between sutures and staples. It was demonstrated that suturing skin requires more time and staples are more painful to remove. TRIAL REGISTRATION:Clinicaltrials.gov identifier NCT01146236 (registered June 14, 2010).

SUBMITTER: Slade Shantz JA

PROVIDER: S-EPMC3598732 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

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Sutures versus staples for wound closure in orthopaedic surgery: a pilot randomized controlled trial.

Slade Shantz Jesse A JA Vernon James J Morshed Saam S Leiter Jeff J Stranges Gregory G

Patient safety in surgery 20130209 1

<h4>Background</h4>In the spectrum of surgical decision-making, wound closure material is often an afterthought. However, the findings of a recent meta-analysis suggest that the rate of surgical site infections (SSIs) is increased by using staples to close surgical wounds. Less clear is the effect of closure material on the incidence of non-infectious wound complications.The aim of this study was to compare sutures and staples in terms of: incidence of wound complications to determine the sample ...[more]

PMID: 23394586

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Project description:BACKGROUND:A recently published meta-analysis comparing metallic staples to sutures in orthopaedic procedures revealed three fold increase in risk for infection in stapled wounds. The studies included in the meta-analysis are at risk of bias due to experimental design limitations. A large randomized controlled trial is proposed to direct orthopaedic surgeons in their choice of wound closure material. METHODS/DESIGN:A parallel group randomized controlled trial with institutional review board approval will be conducted. Patients will be randomized intraoperatively to have skin wounds closed with sutures or staples. Dressings will be used to maintain blinding outcome assessors. The primary outcome measure will be a composite all-cause wound complication outcome measure composed of: infection, wound drainage, wound necrosis, blistering, dehiscence, suture abscess and material sensitivity reaction. An independent review board blinded to treatment assignment will adjudicate suspected complications based on clinical data. All deceased patients will also be reviewed. An interim analysis of complications will take place after half of the patients have been recruited. All data will be analyzed by a blinded statistician. Dichotomous primary and secondary outcome measures will be analyzed using the Chi-squared statistic. Continuous outcome measures will be analyzed using Student's?t-test. Subgroup analysis will compare infection rates using sutures versus staples in each anatomic area (upper extremity, pelvis/acetabulum, hip/femur, knee, ankle). A further subgroup analysis will be conducted comparing trauma patients to elective surgery patients. Non-infected revision surgery will also be compared to primary surgery. DISCUSSION:Wound closure material is an afterthought for many orthopaedic surgeons. The combined results of several comparative trials suggests that the choice of wound closure materials may have an impact on the rate of surgical site infections. However, the strength of the evidence is poor given the heterogeneity of the methods employed in previous studies. The following study protocol aims to guide surgeons in their choice of wound closure material by determining if there is a difference in complication rates in sutured and stapled wounds. TRIAL REGISTRATION:This trial was registered at ClinicalTrials.gov under the identifier NCT01146236 (registered June 14, 2010).

Project description:ObjectiveTo compare the clinical outcomes of staples versus sutures in wound closure after orthopaedic surgery.DesignMeta-analysis.Data sourcesMedline, CINAHL, AMED, Embase, Scopus, and the Cochrane Library databases were searched, in addition to the grey literature, in all languages from 1950 to September 2009. Additional studies were identified from cited references. Selection criteria Two authors independently assessed papers for eligibility. Included studies were randomised and non-randomised controlled trials that compared the use of staples with suture material for wound closure after orthopaedic surgery procedures. All studies were included, and publications were not excluded because of poor methodological quality. Review methods Two authors independently reviewed studies for methodological quality and extracted data from each paper. Final data for analysis were collated through consensus. The primary outcome measure was the assessment of superficial wound infection after wound closure with staples compared with sutures. Relative risk and mean difference with 95% confidence intervals were calculated and pooled with a random effects model. Heterogeneity was assessed with I(2) and chi(2) statistical test.ResultsSix papers, which included 683 wounds, were identified; 332 patients underwent suture closure and 351 staple closure. The risk of developing a superficial wound infection after orthopaedic procedures was over three times greater after staple closure than suture closure (relative risk 3.83, 95% confidence interval 1.38 to 10.68; P=0.01). On subgroup analysis of hip surgery alone, the risk of developing a wound infection was four times greater after staple closure than suture closure (4.79, 1.24 to 18.47; P=0.02). There was no significant difference between sutures and staples in the development of inflammation, discharge, dehiscence, necrosis, and allergic reaction. The included studies had several major methodological limitations, including the recruitment of small, underpowered cohorts, poorly randomising patients, and not blinding assessors to the allocated methods of wound closure. Only one study had acceptable methodological quality.ConclusionsAfter orthopaedic surgery, there is a significantly higher risk of developing a wound infection when the wound is closed with staples rather than sutures. This risk is specifically greater in patients who undergo hip surgery. The use of staples for closing hip or knee surgery wounds after orthopaedic procedures cannot be recommended, though the evidence comes from studies with substantial methodological limitations. Though we advise orthopaedic surgeons to reconsider their use of staples for wound closure, definitive randomised trials are still needed to assess this research question.

Project description:To compare wound complication rates after skin closure with staples and subcuticular suture in obese gynecology patients undergoing laparotomy through a midline vertical incision.In this randomized controlled trial, women with body mass indexes (BMIs) of 30 or greater undergoing surgery by a gynecologic oncologist through a midline vertical incision were randomized to skin closure with staples or subcuticular 4-0 monofilament suture. The primary outcome was the rate of wound complication, defined as the presence of a wound breakdown, or infection, within 8 weeks postoperatively. Secondary outcomes included operative time, Stony Brook scar cosmetic score, and patient satisfaction. A sample size of 162 was planned to detect a 50% reduction in wound complications. At planned interim review (n=82), there was no significant difference in primary outcome.Between 2013 and 2016, 163 women were analyzed, including 84 who received staples and 79 suture. Women who received staples were older (mean age 59 compared with 57 years), had lower mean BMI (37.3 compared with 38.9), and fewer benign indications for surgery (22 compared with 27). There were no differences in wound complication rates between staple compared with suture skin closure (28 [33%] compared with 25 [32%], relative risk 1.05, 95% confidence interval [CI] 0.68-1.64). Women with staples reported worse median cosmetic scores (four of five compared with five of five, P<.001), darker scar color (37 [49%] compared with 13 [18%], relative risk 2.69, 95% CI 1.57-4.63), and more skin marks (30 [40%] compared with three [4%], relative risk 9.47, 95% CI 3.02-29.65) compared with women with suture closure. There was no group difference regarding satisfaction with their scar. Stepwise multivariate analysis revealed BMI (odds ratio [OR] 1.13, 95% CI 1.07-1.20), maximum postoperative glucose (OR 1.01, 95% CI 1.00-1.01), and cigarette smoking (OR 4.96, 95% CI 1.32-18.71) were correlates of wound complication.Closure of midline vertical skin incisions with subcuticular suture does not reduce surgical site wound complications compared with staples in obese gynecology patients.ClinicalTrials.gov, NCT01977612.

Project description:BackgroundThe primary objective of this systematic review is to examine the characteristics of pilot randomized controlled trials (RCTs) in the orthopaedic surgery literature, including the proportion framed as feasibility trials and those that lead to definitive RCTs. This review aim to answer the question of whether pilot RCTs lead to definitive RCTs, whilst investigating the quality, feasibility and overall publication trends of orthopaedic pilot trials.MethodsPilot RCTs in the orthopaedic literature were identified from three electronic databases (EMBASE, MEDLINE, and Pubmed) searched from database inception to January 2018. Search criteria included the evaluation of at least one orthopaedic surgical intervention, research on humans, and publication in English. Two reviewers independently screened the pool of pilot trials, and conducted a search for corresponding definitive trials. Screened pilot RCTs were assessed for feasibility outcomes related to efficiency, cost, and/or timeliness of a large-scale clinical trial involving a surgical intervention. The quality of the pilot and definitive trials were assessed using the Checklist to Evaluate a Report of a Non-Pharmacological Trial (CLEAR NPT).ResultsThe initial search for pilot RCTs yielded 3857 titles, of which 49 articles were relevant for this review. 73.5% (36/49) of the orthopaedic pilot RCTs were framed as feasibility trials. Of these, 5 corresponding definitive trials (10.2%) were found, of which four were published and one ongoing. Based on author responses, the lack of a definitive RCT following the pilot trial was attributed to a lack of funding, inadequacies in recruitment, and belief that the pilot RCT sufficiently answered the research question.ConclusionsBased on this systematic review, most pilot RCTs were characterized as feasibility trials. However, the majority of published pilot RCTs did not lead to definitive trials. This discrepancy was mainly attributed to poor feasibility (e.g. poor recruitment) and lack of funding for an orthopaedic surgical definitive trial. In recent years this discrepancy may be due to researchers saving on time and cost by rolling their pilot patients into the definitive RCT rather than publish a separate pilot trial.

Project description:ImportanceAlthough applying adhesive strips to a wound closure has been shown to have outcomes equivalent to those with cuticular suturing, it is unknown whether adhesive strips provide additional benefit compared with dermal suturing alone.ObjectiveTo determine whether the addition of adhesive strips to a wound closed with buried interrupted subcuticular sutures improves outcomes following wound closure.Design, setting, and participantsA prospective, randomized split-wound intervention was conducted between November 14, 2013, and May 16, 2014, in patients who underwent cutaneous surgical procedures at the University of California, Davis, outpatient dermatology clinic. Fifty-seven patients 18 years or older with postoperative defects of at least 3 cm, resulting from either Mohs micrographic surgical procedures or surgical excision, were screened for participation. Nine patients were excluded and 48 were enrolled.InterventionsHalf of each wound was randomized to receive buried interrupted subcuticular sutures and overlying adhesive strips and the other half received buried interrupted subcuticular sutures only.Main outcomes and measuresAt 3 months' follow-up, each patient and 2 blinded observers evaluated the wound using the Patient Observer Scar Assessment Scale.ResultsThe total mean (SD) Patient Observer Scar Assessment Scale score for observers for the side that received a combination of adhesive strips and buried interrupted subcuticular suturing (12.3 [4.8]) and the side that received sutures only (12.9 [6.3]) did not differ significantly at 3 months (P = .32). There was no significant difference in the total patient assessment scale score between the combination closure (14.0 [7.6]) and sutures only (14.7 [7.6]) sides at 3 months (P = .39). There was also no significant difference between the 2 closure methods in terms of mean (SD) scar width (both methods: 1.1 [0.8] mm, P = .89) at follow-up.Conclusions and relevanceCombination closure with adhesive strips and buried interrupted subcuticular suturing was not significantly associated with improved overall scar assessment compared with buried interrupted subcuticular suturing alone when evaluated by blinded observers or the patients themselves. Our results do not support the use of adhesive strips as a means to improve cosmetic outcomes or reduce scar width.Trial registrationclinicaltrials.gov Identifier: NCT01979497.

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Sutures versus staples for wound closure in orthopaedic surgery: a pilot randomized controlled trial.

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Sutures versus staples for wound closure in orthopaedic surgery: a pilot randomized controlled trial.

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