A Prospective, Randomized, Controlled, Single-blind, Multicenter Clinical Trial Evaluating the Safety and Efficacy of the Cohera TissuGlu® Surgical Adhesive in the Management of Wound Drainage as Compared to the Standard of Care Closure Techniques Following Abdominoplasty
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Time to reach drain removal criteria.
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of the device while reducing the amount of drainage from surgical wounds following large flap surgical procedures, in this case abdominoplasty, as compared to the standard of care (closure techniques). It is hypothesized that the use of the Cohera device will facilitate reduction or closure of dead space when applied to planar surfaces created during an abdominoplasty procedure.
详细描述
Background:
Fluid accumulation in dissected tissue planes has been a longstanding problem following surgical procedures. The common use of closed suction drains has been associated with infection risk, wound healing complications, additional scarring, and patient discomfort. Additionally, seroma formation after drain removal often requires invasive treatment. Therapies that can reduce fluid accumulation and decrease the need for drains will have a positive impact on surgical practice.
Objectives:
- To establish that the use of TissuGlu® Surgical Adhesive is a safe and effective alternative to drains (standard of care) for fluid management following abdominoplasty.
- To evaluate the impact of TissuGlu® Surgical Adhesive on post-operative invasive treatments, and seroma formation.
- To evaluate the impact of TissuGlu® Surgical Adhesive on post-operative subject satisfaction and quality of life.
- To document the type and duration of adverse events associated with TissuGlu® used during an abdominoplasty procedure as an alternative to drains.
Material and Methods:
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 85 Years（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;
- •BMI ≤ 35;
- •≤ ASA2 - American Society of Anesthesiologists (ASA) Physical Classification System (2=patient with mild systemic disease);
- •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.
- •Be willing to follow instructions for incision care, wound exudates volume measurements, and diary completion as instructed by the investigator, and follow guidelines related to resumption of daily activities;
- •Agree to return for all follow-up evaluations specified in this protocol
- •Agree not to schedule any additional elective surgical procedures that involve an incision on the abdomen, until their participation in this study is complete; and
- •Sign the informed consent
排除标准
- •Exclusion Criteria:
- •Pregnant or breastfeeding
- •Previous abdominoplasty;
- •Concurrent liposuction during procedure;
- •Use of pain pumps;
- •Have severe co-morbid conditions (e.g., heart disease);
- •Known medical condition that results in compromised blood supply to tissues;
- •Any condition known to effect wound healing, such as collagen vascular disease;
- •Are currently a smoker or have smoked within 30 days of prescreening as determined by nicotine test;
- •Be known to have a blood clotting disorder and/or be willing to discontinue anti-coagulation therapy - including aspirin;
- •Diagnosis of diabetes with current medical treatment;
- •Be receiving antibiotic therapy for pre-existing condition or infection;
- •Have known personal or family history of keloid formation or hypertrophic scarring;
- •Undergoing concurrent adjacent or congruent Liposuction procedures;
- •Concurrent use of fibrin sealants or other internal wound care devices;
- •Be currently taking systemic steroids or immunosuppressive agents;
- •Concurrent hernia repair greater than 6 cm and/or requiring the use of mesh;
- •Mini abdominoplasty (Abdominoplasty without umbilical transposition);
- •Have known or suspected allergy or sensitivity to any test materials or reagents; and
- •Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study.
结局指标
主要结局
Time to reach drain removal criteria.
时间窗: Measured until drains are removed, up to 30 days post-op.
Primary efficacy endpoint is time (days) to reach drain removal criteria of less than 30ml per 24hr period.
次要结局
未报告次要终点