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

NCT ID: NCT01114451

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-02-29

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.

Conditions

Wound Complications; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Staple Removal

Skin staple removal on post-operative day #3

Group Type: EXPERIMENTAL

Removal of surgical skin staples

Intervention Type: PROCEDURE

Skin staples will be removed using standard technique with subsequent placement of steri-trips

Delayed Staple Removal

Skin staple removal on post-operative day 7-10

Group Type: EXPERIMENTAL

Removal of surgical skin staples

Intervention Type: PROCEDURE

Skin staples will be removed using standard technique with subsequent placement of steri-trips

Interventions

Removal of surgical skin staples

Skin staples will be removed using standard technique with subsequent placement of steri-trips

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Prisma Health-Upstate

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis S Nuthalapaty, MD

Role: PRINCIPAL_INVESTIGATOR

Prisma Health-Upstate

Locations

Greenville Memorial Hospital

Greenville, South Carolina, United States

Countries

United States

References

Nuthalapaty FS, Rouse DJ. The impact of obesity on obstetrical practice and outcome. Clin Obstet Gynecol. 2004 Dec;47(4):898-913; discussion 980-1. doi: 10.1097/01.grf.0000135358.34673.48. No abstract available.

Reference Type: BACKGROUND

PMID: 15596944 (View on PubMed)

Sarsam SE, Elliott JP, Lam GK. Management of wound complications from cesarean delivery. Obstet Gynecol Surv. 2005 Jul;60(7):462-73. doi: 10.1097/01.ogx.0000166603.43959.aa.

Reference Type: BACKGROUND

PMID: 15995563 (View on PubMed)

Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. doi: 10.1016/j.ajog.2005.03.063.

Reference Type: BACKGROUND

PMID: 16260200 (View on PubMed)

American College of Obstetricians and Gynecologists. ACOG Committee Opinion number 315, September 2005. Obesity in pregnancy. Obstet Gynecol. 2005 Sep;106(3):671-5. doi: 10.1097/00006250-200509000-00054.

Reference Type: BACKGROUND

PMID: 16135613 (View on PubMed)

Walsh C, Scaife C, Hopf H. Prevention and management of surgical site infections in morbidly obese women. Obstet Gynecol. 2009 Feb;113(2 Pt 1):411-5. doi: 10.1097/AOG.0b013e3181945625. No abstract available.

Reference Type: BACKGROUND

PMID: 19155915 (View on PubMed)

Other Identifiers

Pro00002576

Identifier Type: -

Identifier Source: org_study_id