Comparison of Outcome of Post Burn Flexion Contracture Release Under Tourniquet Verses Tumescent Technique in Children
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Percentage graft taken
研究概览
简要总结
Post burn flexion contractures are common in pediatric age group. Release of contracture and coverage with full thickness skin graft (FTSG) is a widely used procedure for this problem. This procedure is routinely done under tourniquet control because bloodless operative field is essential to visualize important neurovascular structures in hand.
Use of tumescent technique without a tourniquet is gaining acceptance because it avoids complications associated with tourniquet use, maintains a blood less surgical field and decreases operative time. Furthermore use of tumescent anesthesia often results in better surgical outcomes.
Although the benefits of tumescent technique used in wide awake hand surgery are well documented, epinephrine at a concentration of 1:1 000,00 has also been used as a replacement for pneumatic tourniquet for release of hand contracture in infants and adults under general anesthesia. Thus epinephrine 1:1,000,00 in saline solution can be a potential replacement for a tourniquet in hand surgeries done under general anesthesia.
详细描述
Post burn flexion contractures are common in pediatric age group. Release of contracture and coverage with full thickness skin graft (FTSG) is a widely used procedure for this problem. This procedure is routinely done under tourniquet control because bloodless operative field is essential to visualize important neurovascular structures in hand.
Use of tumescent technique without a tourniquet is gaining acceptance because it avoids complications associated with tourniquet use, maintains a blood less surgical field and decreases operative time. Furthermore use of tumescent anesthesia often results in better surgical outcomes.
Although the benefits of tumescent technique used in wide awake hand surgery are well documented, epinephrine at a concentration of 1:1 000,000 has also been used as a replacement for pneumatic tourniquet for release of hand contracture in infants and adults under general anesthesia. Thus epinephrine 1:1,000,000 in saline solution can be a potential replacement for a tourniquet in hand surgeries done under general anesthesia.
To the investigators' knowledge no study has so far been done to compare the outcome of release of post burn flexion contractures under tumescent technique with general anesthesia or under tourniquet control with general anesthesia.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with post burn flexion contractures involving volar aspect of palm and fingers
- •Possible to cover the defect with full thickness skin graft
- •age range of 3 to 12 years.
- •Patients of both genders
排除标准
- •Children with recurrent post burn contractures.
- •Children with any history of bleeding diathesis or coagulopathy.
- •Children with any co-morbid condition making any contraindication of general anesthesia.
- •Patients having previous history of vascular insufficiency like Raynaud's disease or phenomenon, severe peripheral vascular disease and peripheral neuropathy.
- •The patient having allergic hypersensitivity to epinephrine, lidocaine.
研究组 & 干预措施
Tourniquet Group
Post burn flexion contractures will be released under tourniquet control
干预措施: post burn flexion contractures release under tourniquet control (Procedure)
Tourniquet Group
Post burn flexion contractures will be released under tourniquet control
干预措施: Contracture release and application of FTSG (Procedure)
Tumescent technique group
Post burn flexion contractures will be released using Tumescent solution
干预措施: post burn flexion contractures release using tumescent solution (Procedure)
Tumescent technique group
Post burn flexion contractures will be released using Tumescent solution
干预措施: Contracture release and application of FTSG (Procedure)
结局指标
主要结局
Percentage graft taken
时间窗: 14th day post surgery
It will be measured by the percentage of graft take at 14th post-operative day. Percentage graft take = Graft secured at the time of operation measured by using transparent graph paper / graft take at 14th post-operative day measured by using transparent graph paper.
Post-operative pain (FLACC scale)
时间窗: At 24th hour after arrival in ward following surgery
Post-operative pain will be measured by blinded on duty doctor using Face Leg Activity Cry Consolability (FLACC) scale. Postoperative pain will be measured by using FLACC pain scale by blinded observer at 24th hour postoperatively taking time of arrival in the ward as zero hour.
Operative time to secure graft
时间窗: Time of surgery
Operative time to secure graft will be measured by calculating the time taken to secure per square centimeter of graft. Time (T) in minutes to secure per cm2 of graft = Total operative time / size of graft secured in cm2 measured by transparent graft paper In tourniquet group total operative time will be measured as total time taken from start of applying tourniquet including time taken for exsanguinations to the time till completion of dressing. In tumescent group total operative time will be measured as total time taken from start of injecting the tumescent solution including waiting time for tumescent solution to produce maximum vasoconstriction (25 minutes) to the time till completion of dressing
Post-operative pain (FLACC scale)
时间窗: At First hour after arrival in ward following surgery
Post-operative pain will be measured by blinded on duty doctor using Face Leg Activity Cry Consolability (FLACC) scale. Postoperative pain will be measured by using FLACC pain scale by blinded observer at first hour postoperatively taking time of arrival in the ward as zero hour
Post-operative pain (FLACC scale)
时间窗: At 6th hour after arrival in ward following surgery
Post-operative pain will be measured by blinded on duty doctor using Face Leg Activity Cry Consolability (FLACC) scale. Postoperative pain will be measured by using FLACC pain scale by blinded observer at 6th hour postoperatively taking time of arrival in the ward as zero hour.
Post-operative pain (FLACC scale)
时间窗: At 12th hour after arrival in ward following surgery
Post-operative pain will be measured by blinded on duty doctor using Face Leg Activity Cry Consolability (FLACC) scale. Postoperative pain will be measured by using FLACC pain scale by blinded observer at 12th hour postoperatively taking time of arrival in the ward as zero hour.
次要结局
未报告次要终点
研究者
Muhammad Mustehsan Bashir
Associate professor of Plastic Surgery
King Edward Medical University