Multi-centre Study to Show Equivalence of Prineo (Dermabond Protape) to Intradermal Sutures for Skin Closure of Full-thickness Surgical Incisions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 5
- 主要终点
- Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups.
研究概览
简要总结
This is a prospective, controlled, randomized, multi-center clinical study of up to 80 subjects with full thickness surgical incisions. Each incision included in the study will be segmented into two halves; each half will be randomized to receive final skin closure with either Prineo (DERMABOND PROTAPE) or intradermal sutures. Subjects will be evaluated post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be at least 18 years of age;
- •Be in good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications;
- •Be scheduled for at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty or body lift procedures, requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure;
- •Be willing to follow instructions for incision care as instructed by the investigator, and refrain from swimming or soaking in a tub during the first 12 - 25 days of the study;
- •Agree to return for all follow-up evaluations specified in this protocol [7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days)], six (± 1 month) and twelve months (± 1 month)];
- •Agree not to schedule any additional elective surgical procedures that involve an incision that is randomized for inclusion in this study, until their participation in this study is complete; and
- •Sign the informed consent.
排除标准
- •Have peripheral vascular disease;
- •Have insulin dependent diabetes mellitus;
- •Be known to have a blood clotting disorder;
- •Be receiving antibiotic therapy for pre-existing condition or infection;
- •Be known to be HIV-positive or otherwise immunocompromised;
- •Have known personal or family history of keloid formation or hypertrophy;
- •Be currently taking systemic steroids;
- •Have known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives
- •Have incision type or location known to have an incidence of cyanosis or other healing abnormalities; and
- •Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrolment in this study.
结局指标
主要结局
Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups.
时间窗: 12-25 days post-operation
Equivalence is demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) does not exceed 12%.
次要结局
- Time Required to Close the Final Skin Layer(Intraoperative)
- Cosmetic Outcome(12 month)