NCT00196508已完成3 期
A Randomized, Multi Center Study to Evaluate the Clinical Performance of Topical Skin Adhesive in Comparison to Sutures for Perineal Skin Closure Following Childbirth
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 9
- 主要终点
- Topical skin adhesive is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth
研究概览
简要总结
This is a randomized controlled trial and multi-centered study with a 2-arm design. The treatment group will receive topical skin adhesive for skin closure of their wound and the control will receive sutures. Subjects will be assessed at follow-up visits. Patients are required to maintain a diary postpartum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient is at least 18 years of age.
- •Patient has an episiotomy incision or perineal tear resulting from a vaginal delivery.
- •Patient agrees to participate in the follow-up schedule of assessments and completion of a daily diary.
- •Patient has signed the informed consent form.
排除标准
- •Patient has peripheral vascular disease.
- •Patient has insulin dependent diabetes mellitus.
- •Patient has a blood clotting disorder that requires therapy.
- •Patient has a personal or family history of keloid formation or hypertrophy.
- •Patient has a known allergy to cyanoacrylates or formaldehyde.
- •Patient has impaired wound healing by history. Patient is a chronic steroid user.
结局指标
主要结局
Topical skin adhesive is non-inferior to sutures when used for skin closure following an episiotomy incision or perineal tear resulting from childbirth
The incidence of perineal skin opening requiring re-closure post-partum
次要结局
- Presence and extent of clinically relevant skin openings
- Presence and extent of acute inflammatory reaction, pain, itch and discomfort associated with the perineal skin area
- Perineal skin closure cosmesis
- Patient satisfaction
研究者
研究点 (9)
Loading locations...
相似试验
进行中（未招募）
不适用
Treatment of Knee Osteoarthritis With PAAG-OAOsteoarthritis, KneeNCT04045431Contura238
招募中
3 期
Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for LymphomaNon-Hodgkin's LymphomaHematopoietic Stem Cell MobilizationNCT06520163The Affiliated People's Hospital of Ningbo University99
已完成
2 期
Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular DystrophyDuchenne Muscular DystrophyNCT03039686Hoffmann-La Roche166
已完成
2 期
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)Notalgia ParestheticaPruritusNCT04706975Cara Therapeutics, Inc.126
已完成
2 期
Evaluating the Effects of VQW-765 vs. Placebo in Performance AnxietyPerformance AnxietyNCT04800237Vanda Pharmaceuticals230