Early Versus Delayed Skin Staple Removal Following Cesarean Delivery in the Obese Patient

March 15, 2021 updated by: Prisma Health-Upstate

A Randomized Controlled Trial of Early Versus Delayed Skin Staple Removal Following Cesarean Delivery in the Obese Patient

Whenever a person has a cesarean section there is a risk that there will be a problem with healing of the wound. The most common type of wound healing problem is separation and opening of the skin and fatty tissue just beneath the skin. This type of wound healing problem happens more often when the patient has a high body weight. In most cases, metal staples are used to bring the skin together to close the wound. Usually, the staples are left in place for a longer time when the woman is heavy, in hopes of decreasing the chance of wound healing problems. But it is not known if leaving the staples in for a longer time is actually helpful. In some cases, leaving the staples in longer may cause more pain and will require you to see the doctor again to get the staples taken out. The purpose of this study is to see if there is any difference in how the wound heals in heavy women after cesarean section when the skin staples are removed after a short period of time versus a long period of time.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Cesarean delivery in the obese gravida is associated with numerous perioperative risks, the most frequent of which is postoperative wound disruption, with a mean incidence of 15%. With the exception of closure of the subcutaneous adipose layer, other useful measures to decrease wound complications in the obese gravida have either not been studied or lack sufficient evidence upon which to base a recommendation.

One such intervention is the delayed removal of surgical skin staples. Skin staplers, which were first introduced in the 1980's, were "grandfathered" through the United States Food and Drug Administration (FDA) approval process, and have since become a widely utilized technique for skin closure. Although neither the FDA nor device manufacturers make a specific recommendation, skin staples are commonly left in situ anywhere from 3 - 10 days.

The physiologic rationale for delayed staple removal is unclear. Wound healing involves four main stages including hemostasis, inflammation, granulation, and remodeling. Each phase can be further broken down into overlapping steps. Reapproximation of the skin edges with staples enables epithelialization, resulting in wound closure by a thin layer of cells by 48 hours post-operatively. Although overall wound healing appears to be delayed in the setting of obesity, whether the specific process of epithelialization is affected is unknown. Therefore, there may not be a physiologic basis for delaying staple removal in obese women.

Furthermore, delayed staple removal has potentially negative effects on patient care that may not be balanced by clinical benefits. Delayed staple removal may be associated with prolongation of patient discomfort, additional clinical visits and increased associated costs. These issues caused us to question whether the practice of delayed skin staple removal in obese women is warranted.

Therefore, this clinical trial is designed to compare wound healing outcomes after cesarean following early (postoperative day #3) versus delayed (postoperative day #7 - 10) skin staple removal in the obese patient.

Study Type

Interventional

Enrollment (Actual)

292

Phase

  • Phase 2
  • Phase 3

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
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Memorial Hospital

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 52 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Cesarean delivery
  • Body Mass Index ≥ 30 kg/m2
  • Transverse (Pfannenstiel or Joel-Cohen) skin incision
  • Subcutaneous wound depth ≥ 2 cm
  • Surgical staple skin closure

Exclusion Criteria:

  • Vertical skin incision
  • Non-staple skin closure
  • Wound complication (superficial dehiscence, abscess, seroma, hematoma, cellulitis)
  • Any complication necessitating prolonged hospitalization

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
Experimental: Early Staple Removal
Skin staple removal on post-operative day #3
Procedure: Removal of surgical skin staples
Skin staples will be removed using standard technique with subsequent placement of steri-trips
Experimental: Delayed Staple Removal
Skin staple removal on post-operative day 7-10
Procedure: Removal of surgical skin staples
Skin staples will be removed using standard technique with subsequent placement of steri-trips

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with a superficial wound disruption as a measure of efficacy.
Time Frame: 7-10 days after surgery
Any separation of the wound edge measuring greater than 1 cm that occurs from the time of staple placement to final wound assessment which occurs at 7-10 days after surgery.
7-10 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who develop a wound seroma.
Time Frame: 6 weeks after surgery
A collection of fluid within the subcutaneous fatty tissue layer.
6 weeks after surgery
Number of participants who develop a hematoma of the wound.
Time Frame: 6 weeks after surgery
A collection of clotted blood within the subcutaneous tissues.
6 weeks after surgery
Number of participants who develop a surgical site infection
Time Frame: 6 weeks after surgery
Infection involving only skin or subcutaneous tissue of the incision which occurs within 30 days after the operation.
6 weeks after surgery
Frequency of Visual Analogue Pain Score
Time Frame: 7-10 days after surgery
Patient rating of pain on a 1-10 scale as assessed at the 7-10 day postoperative visit.
7-10 days after surgery

Collaborators and Investigators

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

Sponsor

Prisma Health-Upstate

Investigators

  • Principal Investigator: Francis S Nuthalapaty, MD, Prisma Health-Upstate

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

October 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

April 16, 2010

First Submitted That Met QC Criteria

April 30, 2010

First Posted (Estimate)

May 3, 2010

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00002576

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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