A Comparison of Skin Closure Techniques After Primary Cesarean Delivery
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Time needed to close skin.
研究概览
简要总结
A Comparison of Skin Closure Techniques after Primary Cesarean Delivery. Traci N. Gray, M.D. and Peter F. Schnatz, D.O.
A prospective, observer blinded, randomized, and controlled trial comparing Dermabond closure technique to suture closure of skin.
Study Participants: All women age 18years or older who provide informed consent prior to primary Cesarean delivery at Hartford Hospital. Women with vertical skin incisions and or who are febrile preop or intraop will be excluded.
Methods: Qualified participants will then be randomized to skin closure with either Dermabond or suture. Surgeon preference will dictate usage of 4-0 monocryl or 4-0 vicryl for skin closure for patients randomized to the suture arm.
- The circulating nurse will time all skin closures.
- The surgeon will complete a 3 question survey immediately postop.
- At the 6 week post partum visit, patients and the health care professional will complete a brief query regarding cosmetic appeal and pain. A disposable camera will be supplied to each provider office and a photo will be taken of the incision.
- All photos will be evaluated for cosmesis by physicians who will be blinded to the methods of skin closure.
Primary Outcomes: To compare the time needed to close skin. To compare cosmetic outcome after healing
Secondary Outcomes: Patient Pain scores. Provider and patient satisfaction. Responses to questions.
详细描述
Introduction:
Much of the practice of surgical wound closure and subsequent care is based upon tradition and individual preference rather than science. Most patients undergoing cesarean deliveries at Hartford Hospital have a subcuticular running closure. Occasionally, patients have a staple closure, at the discretion of the operating surgeon. With newly introduced wound closure techniques, we intend to compare an approved closure technique (Dermabond) with the more traditional suture closure via a prospective, observer blinded, randomized, controlled trial.
Methods:
Study participants will include all women who provide informed consent prior to undergoing cesarean section at Hartford Hospital. Patients will be excluded from the study if they will require a vertical skin incision; are allergic to Dermabond; or have a temperature > 100.2 F preop or intraop. Qualified patients will then be randomized to skin closure with either the Dermabond wound closure technique or suture.
Closure method randomization will be performed prospectively by placing closure modality options in opaque sealed envelopes prior to the initiation of the study. The envelopes will be available in the operating room. The circulating nurse will open the envelope to reveal the randomization arm prior to skin closure and the surgeon will utilize the indicated technique. The circulating nurse will record the length of time needed to close the skin incision. The surgeon will complete a short survey immediately post operatively regarding ease of use of the closure modality as well as expected cosmetic outcome.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing a primary Cesarean Delivery
- •Eighteen years of age or older
排除标准
- •Allergy to Dermabond
- •Fever pre or intra operatively
- •The need for a vertical skin incision
结局指标
主要结局
Time needed to close skin.
Cosmetic outcome after healing
次要结局
- Patient Pain scores.
- Provider and patient satisfaction.
- Responses to questions.
