A Randomized Controlled Trial of Early Versus Delayed Skin Staple Removal Following Cesarean Delivery in the Obese Patient
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 292
- 试验地点
- 2
- 主要终点
- Number of participants with a superficial wound disruption as a measure of efficacy.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 52 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Cesarean delivery
- •Body Mass Index ≥ 30 kg/m2
- •Transverse (Pfannenstiel or Joel-Cohen) skin incision
- •Subcutaneous wound depth ≥ 2 cm
- •Surgical staple skin closure
排除标准
- •Vertical skin incision
- •Non-staple skin closure
- •Wound complication (superficial dehiscence, abscess, seroma, hematoma, cellulitis)
- •Any complication necessitating prolonged hospitalization
结局指标
主要结局
Number of participants with a superficial wound disruption as a measure of efficacy.
时间窗: 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.
次要结局
- Number of participants who develop a hematoma of the wound.(6 weeks after surgery)
- Frequency of Visual Analogue Pain Score(7-10 days after surgery)
- Number of participants who develop a surgical site infection(6 weeks after surgery)
- Number of participants who develop a wound seroma.(6 weeks after surgery)