Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Number of Patients Who Experience One or More Wound Complications
研究概览
简要总结
Obese patients undergoing cesarean section are at high risk for wound complications, which occur in approximately 20% of patients. This is a randomized controlled trial designed to determine whether the risk for wound-related complications can be reduced by covering the incision with a silver-impregnated dressing in the postoperative period.
详细描述
This study's purpose was to evaluate the effect of a FDA approved silver-impregnated dressing on cesarean wound complications in obese women. It was initiated and 37 women were randomized, but because of logistical barriers, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. While a small number of photographs were taken as intended, they were lost due to a technological failure prior to any analysis. Therefore no outcome data could be analyzed. Nonetheless, as patients of the University of Michigan Health System, all research subjects received health care treatment appropriate to their medical condition and circumstances.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Undergoing cesarean section (with or without concurrent tubal ligation)
- •Body mass index (based on most recent weight) >=30
排除标准
- •Known allergy to silver
- •Less than 18 years of age
- •Preoperative evidence of current abdominal wall infection
- •Contraindication to closure of the skin at time of surgery
- •Plan to perform procedures in addition to cesarean section (with or without tubal ligation)
- •Patients with previously placed abdominal wall mesh at site of planned surgery
- •Inability to participate in medical decision making
- •Inability to follow up with the Michigan Visiting Nurses or are unable to return to the University of Michigan Medical Center for staple removal
结局指标
主要结局
Number of Patients Who Experience One or More Wound Complications
时间窗: 6 weeks
A composite of cellulitis, wound dehiscence, seroma, hematoma, abscess, and fascial dehiscence from wound evaluation at any point within six weeks, as pulled from the medical record or based on patient report.
次要结局
- Febrile Morbidity(2 days, 6 weeks)
- Patient Report of Pain Severity and Control(6 weeks)
研究者
Mark Chames, MD
Assistant Professor
University of Michigan