Evidence map›Paper›PMID 28594761›Full record

Trial reportObstetrics and gynecology2017

Wound Complication Rates After Staples or Suture for Midline Vertical Skin Closure in Obese Women: A Randomized Controlled Trial.

Lindsay M Kuroki, Mary M Mullen, L Stewart Massad, Ningying Wu, Jingxia Liu, David G Mutch, Matthew A Powell, Andrea R Hagemann, Premal H Thaker, Carolyn K McCourt and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Obstetrics and gynecology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01977612 (Randomized Controlled Phase IIB Trial Evaluating Wound Complication Rate After Skin Closure With Staples Versus Subcuticular Suture in Patients With BMI >=30), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
3.0field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01977612 phase2completednot on this map

Randomized Controlled Phase IIB Trial Evaluating Wound Complication Rate After Skin Closure With Staples Versus Subcuticular Suture in Patients With BMI >=30

TypeinterventionalSponsorWashington University School of MedicineRan2013 to 2016Enrolled173ConditionsWound Infection, Wound ComplicationArms4-0 monofilament suture, Stainless steel staples
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Subcuticular sutures for skin closure in non-obstetric surgery.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Management of skin and subcutaneous tissue in complex open abdominal wall reconstruction.Hernia : the journal of hernias and abdominal wall surgery · 2018
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Lindsay M KurokiDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, and the Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, and the Alvin J. Siteman Cancer Center, St. Louis, Missouri; and the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology & Women's Health, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, New York.
Mary M Mullen
L Stewart Massad
Ningying Wu
Jingxia Liu
David G Mutch
Matthew A Powell
Andrea R Hagemann
Premal H Thaker
Carolyn K McCourt
Akiva P Novetsky
Montefiore Medical Center · US

Funding

Washington University Center for Cellular ImagingP30CA091842 · NCI · WASHINGTON UNIVERSITY · PI AIMEE S JAMES · 2001 to 2026
$128.0M
WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
Washington University Institute of Clinical and Translational SciencesUL1TR000448 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$41.4M
Paul Calabresis Career Development Award For Clinical Oncology K12CA132783 · NCI · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI PEREZ-SOLER, ROMAN, VERMA, AMIT K. · 2009 to 2019
$8.2M
NCATS NIH HHS UL1 TR000448NCATS NIH HHS UL1 TR002345NCI NIH HHS K12 CA132783NCI NIH HHS P30 CA091842
6 · The paper itself

Abstract

objectiveTo compare wound complication rates after skin closure with staples and subcuticular suture in obese gynecology patients undergoing laparotomy through a midline vertical incision.

methodsIn 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.

resultsBetween 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.

conclusionClosure of midline vertical skin incisions with subcuticular suture does not reduce surgical site wound complications compared with staples in obese gynecology patients. CLINICAL

trial registrationClinicalTrials.gov, NCT01977612.

Indexed as

Obesity, MorbidSuture TechniquesAbdominal Wound Closure TechniquesAdolescentAdultAgedAged, 80 and overFemaleGynecologic Surgical ProceduresHumansMiddle AgedMissouriSurgical Wound DehiscenceSurgical Wound InfectionTreatment OutcomeYoung Adult

Identifiers

PMID28594761
PMCPMC5499520
OpenAlexW2622076712

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.