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

NCT01114451 | Terminated Phase 2

• 1 other identifier: Pro00002576
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Complications; Obesity

Keywords

Cesarean delivery; Obesity; Skin staples; Wound complications

Outcome Measures

Primary Outcomes (1)

• Number of participants with a superficial wound disruption as a measure of efficacy.

  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 Outcomes (4)

• Number of participants who develop a wound seroma.

  6 weeks after surgery

• Number of participants who develop a hematoma of the wound.

  6 weeks after surgery

• Number of participants who develop a surgical site infection

  6 weeks after surgery

• Frequency of Visual Analogue Pain Score

  7-10 days after surgery

Study Arms (2)

Early Staple Removal

EXPERIMENTAL

Skin staple removal on post-operative day #3

Procedure: Removal of surgical skin staples

Delayed Staple Removal

EXPERIMENTAL

Skin staple removal on post-operative day 7-10

Procedure: Removal of surgical skin staples

Interventions

Removal of surgical skin staples PROCEDURE

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

Delayed Staple Removal; Early Staple Removal

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Related Publications (5)

• 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.

  PMID: 15596944 BACKGROUND

• 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.

  PMID: 15995563 BACKGROUND

• 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.

  PMID: 16260200 BACKGROUND

• 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.

  PMID: 16135613 BACKGROUND

• 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.

  PMID: 19155915 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Francis S Nuthalapaty, MD

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: May 3, 2010
• Study Start: October 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: February 1, 2012
• Last Updated: March 17, 2021

Record last verified: 2021-03

Locations

US (1)