A Randomized Trial Evaluating the Use of Fibrin Tissue Adhesive Following Superficial Groin Dissection in Patients With Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Time-to-Drain Removal
研究概览
简要总结
Primary Objective:
- To determine whether the use of a fibrin sealant applied to superficial groin soft tissues following node dissection can result in decreased cumulative postoperative drainage, earlier drain removal, and lower incidence of seroma.
Secondary Objectives:
- To determine the postoperative morbidity rate using fibrin sealant following superficial groin dissection.
- To assess patient-valuation of outcome by performing a cost-benefit analysis using a willingness-to-pay model.
- To determine if serum levels, lymphatic fluids level, or cutaneous expression of vascular endothelial growth factor-D (VEGF-D), vascular endothelial growth factor-C (VEGF-C) or their receptor, vascular endothelial growth factor receptor-3 (VEGFR-3) correlates with nodal tumor burden or development of lymphedema in patients with melanoma.
详细描述
Patients in this study are scheduled to have groin dissection as part of their surgery for treatment of their melanoma.
Within 2 weeks before entry into the study, patients will have a complete physical exam and medical history.
These patients will be randomly assigned (as in the toss of a coin) to one of two groups. Patients in one group will receive TISSEEL applied externally to the dissected groin area. Patients in the other group will receive no fibrin sealant.
For patients who are admitted to the hospital, the surgical site will be monitored by the surgeon for evidence of wound complications in the first 24 hours after surgery. At the time of discharge from the hospital, patients will be instructed in drain care and how to measure the drainage each day until the drain is removed.
The contents of the drain will be collected from patients during the first day after surgery, during the first return follow-up visit to M.D. Anderson Cancer Center, and during drain removal.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Part I - Inclusion Criteria Patients that consent to participate.
- •Patients with melanoma who have undergone superficial node dissection (with or without a concurrent deep (ilioinguinal) node dissection within the last six months as part of their surgical treatment will be considered for the study.
- •Part II- Inclusion Criteria Patients that consent to participate.
- •Patients with melanoma for which a superficial node dissection is indicated (with or without a concurrent deep (ilioinguinal) node dissection.
排除标准
- •Part II - Exclusion Criteria Patients with known hypersensitivity to bovine proteins.
- •Patient has undergone prior radiation therapy to the operative site (groin).
- •Patient is pregnant or lactating.
- •Patient is steroid dependent within last 6 months.
- •Patient has used aspirin or other anti-platelet drug (excluding Celebrex) within seven days of operation.
- •Patients with pre-existing lymphedema.
- •Patients with other pre-existing medical conditions as per the discretion of the principal investigator.
研究组 & 干预措施
Fibrin Sealant
干预措施: Fibrin Sealant (Drug)
结局指标
主要结局
Time-to-Drain Removal
时间窗: From surgery to 30 days post surgery
The superficial groin drain will be removed once cumulative serous drainage volume 30 ml / 24 hours for 2 days or maximum of = or \< 30 days has elapsed since surgery. Time calculated as days from installation of drain at first day of surgery to removal.
次要结局
未报告次要终点