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

This study has been terminated.
(Funding limits exceeded prior to complete enrollment.)
Sponsor:
Information provided by (Responsible Party):
Francis Nuthalapaty, Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier:
NCT01114451
First received: April 16, 2010
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Wound Complications
Obesity
Procedure: Removal of surgical skin staples
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Early Versus Delayed Skin Staple Removal Following Cesarean Delivery in the Obese Patient

Resource links provided by NLM:


Further study details as provided by Greenville Hospital System University Medical Center:

Primary Outcome Measures:
  • Number of participants with a superficial wound disruption as a measure of efficacy. [ Time Frame: 7-10 days after surgery ] [ Designated as safety issue: No ]
    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:
  • Number of participants who develop a wound seroma. [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
    A collection of fluid within the subcutaneous fatty tissue layer.

  • Number of participants who develop a hematoma of the wound. [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
    A collection of clotted blood within the subcutaneous tissues.

  • Number of participants who develop a surgical site infection [ Time Frame: 6 weeks after surgery ] [ Designated as safety issue: No ]
    Infection involving only skin or subcutaneous tissue of the incision which occurs within 30 days after the operation.

  • Frequency of Visual Analogue Pain Score [ Time Frame: 7-10 days after surgery ] [ Designated as safety issue: No ]
    Patient rating of pain on a 1-10 scale as assessed at the 7-10 day postoperative visit.


Enrollment: 292
Study Start Date: October 2009
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 52 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114451

Locations
United States, South Carolina
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
Greenville Hospital System University Medical Center
Investigators
Principal Investigator: Francis S Nuthalapaty, MD Greenville Hospital System University Medical Center
  More Information

Publications:
Responsible Party: Francis Nuthalapaty, Principal Investigator, Greenville Hospital System University Medical Center
ClinicalTrials.gov Identifier: NCT01114451     History of Changes
Other Study ID Numbers: Pro00002576
Study First Received: April 16, 2010
Last Updated: March 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Greenville Hospital System University Medical Center:
Cesarean delivery
Obesity
Skin staples
Wound complications

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014