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Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial.

ABSTRACT: OBJECTIVE:To compare the risk of cesarean wound disruption or infection after closure with surgical staples compared with subcuticular suture. METHODS:Women with viable pregnancies at 24 weeks of gestation or greater undergoing scheduled or unscheduled cesarean delivery were randomized to wound closure with surgical staples or absorbable suture. Staples were removed at postoperative days 3-4 for low transverse incisions and days 7-10 for vertical incisions. Standardized wound evaluations were performed at discharge (days 3-4) and 4-6 weeks postoperatively. The primary outcome was a composite of wound disruption or infection within 4-6 weeks. Secondary outcomes included operative time, highest pain score on analog scale, cosmesis score, and patient scar satisfaction score. Analyses were by intent to treat. RESULTS:Of 398 patients, 198 were randomized to staples and 200 to suture (but four received staples). Baseline characteristics including body mass index, prior cesarean delivery, labor, and type of skin incision were similar by group. The primary outcome incidence at hospital discharge was 7.1% for staples and 0.5% for suture (P<.001, relative risk 14.1, 95% confidence interval [CI] 1.9-106). Of 350 (87.9%) with follow-up at 4-6 weeks, the cumulative risk of the primary outcome at 4-6 weeks was 14.5% for staples and 5.9% for suture (P=.008, relative risk 2.5, 95% CI 1.2-5.0). Operative time was longer with suture closure (median time of 58 versus 48 minutes; P<.001). Pain scores at 72-96 hours and at 6 weeks, cosmesis score, and patient satisfaction score did not differ by group. CONCLUSION:Staples closure compared with suture is associated with significantly increased composite wound morbidity after cesarean delivery. CLINICAL TRIAL REGISTRATION:: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01008449. LEVEL OF EVIDENCE:: I.

SUBMITTER: Figueroa D

PROVIDER: S-EPMC3875219 | biostudies-literature | 2013 Jan

REPOSITORIES: biostudies-literature

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Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial.

Figueroa Dana D Jauk Victoria Chapman VC Szychowski Jeff M JM Garner Rachel R Biggio Joseph R JR Andrews William W WW Hauth John J Tita Alan T N AT

Obstetrics and gynecology 20130101 1

<h4>Objective</h4>To compare the risk of cesarean wound disruption or infection after closure with surgical staples compared with subcuticular suture.<h4>Methods</h4>Women with viable pregnancies at 24 weeks of gestation or greater undergoing scheduled or unscheduled cesarean delivery were randomized to wound closure with surgical staples or absorbable suture. Staples were removed at postoperative days 3-4 for low transverse incisions and days 7-10 for vertical incisions. Standardized wound eval ...[more]

PMID: 23262925

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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:BackgroundSkin closure techniques during minimally-invasive gynecologic surgery is largely based on surgeon preference. The optimum technique would theoretically be safe, rapid, inexpensive, and result in good cosmetic appearance. Cyanoacrylate tissue adhesive (Dermabond) may be a comparable and safe option for port site closure as compared with subcuticular suture. In this randomized clinical trial, we hypothesized that operative time for skin closure would be less than subcuticular suture during robotic urogynecologic procedures.AimTo compare skin closure during robotic urogynecologic surgeries for tissue adhesives and subcuticular suture.MethodsFifty female subjects > 18 years of age undergoing robotic urogynecologic procedures were randomized to have port site closure with either cyanoacrylate tissue adhesive (n = 25) or subcuticular suture (n = 25). All procedures and postoperative evaluations were performed by the same board certified Female Pelvic Medicine and Reconstructive Surgeon. Incisional closure time was recorded. Each subject was followed for 12-wk postoperatively. Incision cosmesis was evaluated using the Stony Brook Scar Evaluation Scale.ResultsA total of 47 subjects (cyanoacrylate group, n = 23; suture group, n = 24) completed the 12-wk postoperative evaluation. Closure time was significantly less (P < 0.0005) using cyanoacrylate tissue adhesive (5.4 ± 2.0 min) than subcuticular suture (24.9 ± 5.6 min). Cosmesis scores were significantly higher in the cyanoacrylate tissue adhesive group than subcuticular suture (P = 0.025). No differences were found between bleeding, infection, or dehiscence (P = 1.00, P = 0.609, P = 0.234, respectively). No statistical demographical differences existed between the two study arms.ConclusionOur study supported our original hypothesis that cyanoacrylate tissue adhesive for port site closure during robotic urogynecolgic procedures uses less time than with subcuticular suture. Our study also supports that tissue adhesive is comparable to cosmetic outcome while not jeopardizing rates of bleeding, infection, or dehiscence.

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.

Dataset Information

Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial.

Publications

Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial.

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