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

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ClinicalTrials.gov Identifier: NCT01114451
Recruitment Status : Terminated (Funding limits exceeded prior to complete enrollment.)
First Posted : May 3, 2010
Last Update Posted : March 19, 2012
Sponsor:
Information provided by (Responsible Party):

April 16, 2010
May 3, 2010
March 19, 2012
October 2009
November 2011   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01114451 on ClinicalTrials.gov Archive Site
  • Number of participants who develop a wound seroma. [ Time Frame: 6 weeks after surgery ]
    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 ]
    A collection of clotted blood within the subcutaneous tissues.
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
Early Versus Delayed Skin Staple Removal Following Cesarean Delivery in the Obese Patient
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Wound Complications
  • Obesity
Procedure: Removal of surgical skin staples
Skin staples will be removed using standard technique with subsequent placement of steri-trips
  • Experimental: Early Staple Removal
    Skin staple removal on post-operative day #3
    Intervention: Procedure: Removal of surgical skin staples
  • Experimental: Delayed Staple Removal
    Skin staple removal on post-operative day 7-10
    Intervention: Procedure: Removal of surgical skin staples

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
292
February 2012
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 52 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01114451
Pro00002576
No
Not Provided
Not Provided
Francis Nuthalapaty, Greenville Hospital System University Medical Center
Greenville Health System
Not Provided
Principal Investigator: Francis S Nuthalapaty, MD Greenville Health System
Greenville Health System
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP