Comparison of Staples Versus Nonabsorbable Subcuticular (Prolene) Suture for Skin Closure in Cesarean Deliveries: A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Level of Pain on a Scale During the Post-operative Hospitalization Period
研究概览
简要总结
Currently different materials are used to close the skin after a cesarean delivery, including absorbable suture, non-absorbable suture and staples. It is not known what is the best choice of material to close the skin after a cesarean section, but commonly staples or dissolvable suture is used. Recently plastic surgeons have found that non-dissolvable suture may have a better cosmetic outcome than staples. The investigators hope to learn if there is a difference in pain both at suture/staple removal and 6 weeks postoperatively between Prolene suture, Absorbable suture (monocryl or vicryl) or staples. The investigators also plan to look for differences in wound complications and patient satisfaction, as well as operating and removal times. This knowledge will be important in helping practitioners choose the closure technique at cesarean delivery.
详细描述
Patients who meet inclusion criteria will be approached upon admission to Labor and Delivery. A study staff member will describe the study and offer participation. If a patient agrees to participate, she will sign research protocol and HIPAA consent forms and receive a copy of these forms. The patient's chart will be flagged, indicating that she is a study participant. The patient's prenatal care and labor and delivery will be managed by her physician per standard of care at the physician's discretion, including routine surgical preparation and procedures.
When a participating patient is scheduled for a cesarean section, she will be randomized to Arm 1 (Staples) or Arm 2 (Prolene) or Arm 3 (Monocryl or Vicryl absorbable suture). She will be treated as per standard of care and her cesarean section performed per physician discretion. After the closure of the fascial layer, the surgeons will follow the same protocol for each study participant, including wound irrigation with warm sterile saline and reapproximation of the subcutaneous layer if greater than 2.0 cm in depth (per standard of care). The patient in Arm 1 will have skin closure with staples. The patient in Arm 2 will have skin closure with 2-0 Prolene in a subcuticular fashion. The patient in Arm 3 will have skin closure with monocryl or vicryl in the standard fashion. Patients in Arms 1 and 2 will have their closure material removed at the physician's discretion per the standard of care at post-operative day 3 or 4.
Pain level will be assessed on the first and third or fourth day after surgery and again at six weeks.
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women undergoing primary or repeat cesarean section
- •Maternal age greater than or equal to 18 years of age
- •Gestational age greater than or equal to 34 weeks
- •Elective and non-elective cesarean section
排除标准
- •Type 1 or Type 2 diabetes
- •BMI greater than 35
- •Pre-operative diagnosis of chorioamnionitis
- •History of drug or alcohol abuse
- •Contraindication to NSAIDs
- •Chronic pain diagnosis
- •Narcotic use prior to pregnancy
- •Maternal age less than 18 years of age
- •General anesthesia
- •Chorioamnionitis, clinical suspicion of chorioamnionitis, or risk factors for chorioamnionitis (membrane rupture greater than 18 hours, GBS positive status)
- •Vertical skin incision
研究组 & 干预措施
Staples
Use of staples for skin closure at cesarean section
干预措施: Staples (Procedure)
Prolene non-absorbable sutures
Use of Prolene non-absorbable sutures for skin closure at cesarean section
干预措施: Prolene non-absorbable sutures (Procedure)
Absorbable sutures
Use of absorbable sutures for skin closure at cesarean section; monocryl or vicryl.
干预措施: Absorbable Sutures (Procedure)
结局指标
主要结局
Level of Pain on a Scale During the Post-operative Hospitalization Period
时间窗: Post-operative day 3 or 4.
Pain level on a Mosby visual analog pain scale of 1 (no pain) to 10 (worst pain)
次要结局
- Time From Skin Incision to the Skin Closure(Day of cesarean delivery (up to 8 hours))
- Level of Pain on a Scale at 6 Weeks Postpartum(Post-operative week 6)
- Count of Participants With Wound Complications(Post-operative week 6)
- Level of Patient Satisfaction to the Wound Appearance(Post-operative day 3 or 4)
- Time Needed for the Suture Removal(Post-operative day 3 or 4)
- Level of Patient Satisfaction to the Wound Appearance at 6 Weeks Postpartum(Post-operative week 6)
- Level of Patient's Satisfaction to the Cosmesis of the Wound(Post-operative week 6)
- Level of Patient's Overall Patient Satisfaction to the Type of Closure(Post-operative week 6)
研究者
Natali Aziz
Clinical Assistant Professor
Stanford University