Comparison of Outcome of Post Burn Flexion Contracture Release Under Tourniquet Verses Tumescent Technique in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Outcome of Post Burn Flexion Contracture Release Under Tourniquet Verses Tumescent Technique in Children

Conditions
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Hand Burns, Flexion Contracture

Intervention / Treatment
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* Procedure: post burn flexion contractures release under tourniquet control
* Procedure: post burn flexion contractures release using tumescent solution
* Procedure: Contracture release and application of FTSG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tourniquet Group<br>Post burn flexion contractures will be released under tourniquet control | Procedure: post burn flexion contractures release under tourniquet control<br>* post burn flexion contractures will be released under tourniquet control<br>Procedure: Contracture release and application of FTSG<br>* Post burn flexion contractures will be released and full thickness skin graft(FTSG) will be applied.<br>|
| Experimental: Tumescent technique group<br>Post burn flexion contractures will be released using Tumescent solution | Procedure: post burn flexion contractures release using tumescent solution<br>* post burn flexion contractures will be released using tumescent solution<br>Procedure: Contracture release and application of FTSG<br>* Post burn flexion contractures will be released and full thickness skin graft(FTSG) will be applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time to secure graft | 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 | Time of surgery | 
| Percentage graft taken | 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. | 14th day post surgery | 
| Post-operative pain (FLACC scale) | 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 | At First hour after arrival in ward following surgery | 
| Post-operative pain (FLACC scale) | 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. | At 6th hour after arrival in ward following surgery | 
| Post-operative pain (FLACC scale) | 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. | At 12th hour after arrival in ward following surgery | 
| Post-operative pain (FLACC scale) | 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. | At 24th hour after arrival in ward following surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burn, hand, flexion contracture, tourniquet, tumescent technique, children