Early Versus Delayed Skin Staple Removal Following Cesarean Delivery in the Obese Patient
| Status: | Archived |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2009 |
| End Date: | December 2013 |
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.
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