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

Phase 2

Terminated

• Conditions: Obesity; Wound Complications
• Interventions: Procedure: Removal of surgical skin staples

• Registration Number: NCT01114451
• Lead Sponsor: Prisma Health-Upstate

Brief Summary

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.

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-04-30
• Study First Posted: 2010-05-03
• Primary Completion: 2011-11
• Study Completion: 2012-02
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 292

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Staple Removal	Removal of surgical skin staples	Skin staple removal on post-operative day #3
Delayed Staple Removal	Removal of surgical skin staples	Skin staple removal on post-operative day 7-10

Primary Outcome Measures

Name	Time	Method
Number of participants with a superficial wound disruption as a measure of efficacy.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Greenville Memorial Hospital; 🇺🇸 Greenville, South Carolina, United States