Randomized Clinical Trial of Skin Closure With Staples Versus Suture

July 26, 2017 updated by: Washington University School of Medicine

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

Women with gynecologic cancers are often obese and have other risk factors for post-operative wound separation. Data from obstetrics and orthopedic surgery literature have shown a decreased risk of wound separation and complications when the skin is closed with suture as compared to staples. Skin closure with either staples or suture is considered standard of care. Traditionally, most wounds have been closed with staples given their ease of use and quick application. In this randomized study the investigators plan to evaluate and compare the complication rate associated with both standard closures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators propose a randomized controlled trial to evaluate for a difference in wound complication rate between closure with sutures that are placed just below the skin level to hold the skin together and metal staples in obese women (BMI>=30) undergoing gynecologic or gynecologic oncology via a midline skin incision for benign or cancer indications under the supervision of one of the full-time faculty members of the Division of Gynecologic Oncology at Washington University School of Medicine.

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All women, >=18 and <= 85 years of age, undergoing surgery, via a midline laparotomy.
  • Body mass index >=30
  • Benign or oncologic indications for surgery.
  • Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery.
  • Surgery will be supervised by one of the gynecologic oncology attendings at Washington University School of Medicine.
  • Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Pfannenstiel or transverse abdominal incision
  • Concomitant panniculectomy or plastic surgery
  • Women <18 years of age
  • History of prior abdominal or pelvic radiation
  • Inability to sign an informed consent form prior to registration on study
  • Inability to understand spoken or written English
  • Prisoner
  • Mental incapacity
  • A history of allergic reactions attributed to either Monocryl suture or stainless steel staples.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stainless Steel Staples
Skin closure with stainless steel staples
Device: Stainless steel staples
Skin closure using stainless steel staples.
Experimental: 4-0 monofilament Sutures
Skin closure with 4-0 monofilament sutures
Device: 4-0 monofilament suture
Skin closure using 4-0 monofilament suture
Other Names:
  • 4-0 Monocryl suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery.
Time Frame: 4-8 weeks post-surgery
4-8 weeks post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Wound Disruption
Time Frame: 4-8 weeks post-surgery
4-8 weeks post-surgery
Incidence of Wound Infection
Time Frame: 4-8 weeks post-surgery
Purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection.
4-8 weeks post-surgery
Operative Time
Time Frame: During surgery
Time from skin incision to the end of skin closure
During surgery
Analog Pain Score on Postoperative Days 3-4
Time Frame: 3-4 days post-surgery
The highest pain score as recorded by nursing staff at a minimum of every 8 hours between 72-96 hours postoperatively.
3-4 days post-surgery
Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score
Time Frame: 4-8 weeks post-operative
  • Ranges from 0 (worst) to 5 (best)
  • Sum of width, height, color, hatch, and overall appearance where a better outcome has a value of 5 and a worse outcome has a value of 0
4-8 weeks post-operative
Median Patient Satisfaction Score of Scar Appearance
Time Frame: 4-8 weeks post-operative
Patients will be asked to rate the general appearance, location and comfort of the scar. This was collected as a continuous variable. Patients were given a paper survey and asked to please draw a single slash across a provided line indicating how satisfied they were with the appearance of their scar. The beginning of the line was designated "very unsatisfied" or 0% and the end of the line was "very satisfied" or 100%.
4-8 weeks post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Lindsay Kuroki, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2013

Primary Completion (Actual)

June 17, 2016

Study Completion (Actual)

June 30, 2016

Study Registration Dates

First Submitted

April 17, 2013

First Submitted That Met QC Criteria

October 30, 2013

First Posted (Estimate)

November 6, 2013

Study Record Updates

Last Update Posted (Actual)

July 31, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201304058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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