Can Fibrin Sealant be Used to Reduce Post-operative Drainage Following Lymph Node Dissection: a Prospective Randomised Double Blind Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 主要终点
- Post-operative Wound Drainage.
研究概览
简要总结
The purpose of this study is to determine whether the use of fibrin sealant reduces post-operative drainage following groin and axillary lymph node dissection.
详细描述
Background: Fibrin sealant has been used for many years in clinical practice and has a wide range of applications including the control of lymphatic leaks and haemostasis. The physiological mechanism of action of fibrin was first described by Morawitz in 1905; fibrin sealant was first marketed in 1983.
Lymph node dissection is undertaken for the control of malignant disease - frequently malignant melanoma or squamous cell carcinoma. Following groin or axillary dissection, excessive post operative drainage may necessitate the presence of wound drains for 10 days or more. This may prolong hospital stay in some patients, and may be associated with an increased complication rate (such as wound infection).
Hypothesis
the use of fibrin sealant prior to wound closure following either groin or axillary dissection may reduce post-operative wound drainage.
Comparison: patients who require an elective groin or axillary dissection who either undergo standard wound closure or those who have fibrin sealant instilled into the surgical wound prior to wound closure.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •Requiring groin or axillary lymph node dissection for malignant disease.
排除标准
- •Patients under age 18 years.
- •Patients unable to speak English.
- •Patients with learning difficulties.
- •Patients with mental illness.
- •Prisoners.
- •Other vulnerable groups.
研究组 & 干预措施
Groin dissection: sealant used.
干预措施: Fibrin Sealant (Tisseel) used in the Experimental Arm. (Drug)
Groin dissection: no sealant used.
干预措施: Fibrin Sealant (Tisseel) used in the Experimental Arm. (Drug)
Axillary dissection: sealant used.
干预措施: Fibrin Sealant (Tisseel) used in the Experimental Arm. (Drug)
Axillary dissection: no sealant used.
干预措施: Fibrin Sealant (Tisseel) used in the Experimental Arm. (Drug)
结局指标
主要结局
Post-operative Wound Drainage.
时间窗: From date of surgery to date of wound drain removal (typically a period of approximately one week).
The postoperative wound drainage volume was measured from the day of surgery until the the date of removal of the last wound drain.
次要结局
- Length of Hospital Inpatient Stay.(From date of surgery until date of discharge from hospital.)
- Length of Time Drains Remain in Situ.(From date of surgery until date of wound drain removal.)
- Number of Patients With Post-operative Complications (Excluding Lymphoedema).(Until wound healing complete.)
- Post Operative Pain Score Measured on 1st Post-operative Day.(During the immediate post-operative period.)
- Disease Recurrence.(From date of surgery until end of study follow-up period (1st June 2010))
- Death.(From day of surgery until end of study follow-up period (1st June 2010))