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

July 16, 2015 updated by: Muhammad Mustehsan Bashir, King Edward Medical University

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tourniquet Group
Post burn flexion contractures will be released under tourniquet control
post burn flexion contractures will be released under tourniquet control
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
Post burn flexion contractures will be released and full thickness skin graft(FTSG) will be applied.
post burn flexion contractures will be released using tumescent solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time to secure graft
Time Frame: 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

Time of surgery
Percentage graft taken
Time Frame: 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.
14th day post surgery
Post-operative pain (FLACC scale)
Time Frame: 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
At First hour after arrival in ward following surgery
Post-operative pain (FLACC scale)
Time Frame: 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.
At 6th hour after arrival in ward following surgery
Post-operative pain (FLACC scale)
Time Frame: 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.
At 12th hour after arrival in ward following surgery
Post-operative pain (FLACC scale)
Time Frame: 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.
At 24th hour after arrival in ward following surgery

Collaborators and Investigators

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Publications and helpful links

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Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

July 12, 2015

First Submitted That Met QC Criteria

July 16, 2015

First Posted (Estimate)

July 17, 2015

Study Record Updates

Last Update Posted (Estimate)

July 17, 2015

Last Update Submitted That Met QC Criteria

July 16, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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