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

Sponsor

King Edward Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02501720

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hand Burns Flexion Contracture	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	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2015

Anticipated Primary Completion Date :

Mar 1, 2016

Anticipated Study Completion Date :

Mar 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Tourniquet Group

Post burn flexion contractures will be released under tourniquet control

Procedure: post burn flexion contractures release under tourniquet control

post burn flexion contractures will be released under tourniquet control

Procedure: Contracture release and application of FTSG

Post burn flexion contractures will be released and full thickness skin graft(FTSG) will be applied.

Experimental: Tumescent technique group

Post burn flexion contractures will be released using Tumescent solution

Procedure: post burn flexion contractures release using tumescent solution

post burn flexion contractures will be released using tumescent solution

Procedure: Contracture release and application of FTSG

Post burn flexion contractures will be released and full thickness skin graft(FTSG) will be applied.

Outcome Measures

Primary Outcome Measures

Operative time to secure graft [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
Percentage graft taken [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) [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) [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) [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.
Post-operative pain (FLACC scale) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.