Comparison of Outcome of Post Burn Flexion Contracture Release Under Tourniquet Verses Tumescent Technique in Children
Primary Purpose
Hand Burns, Flexion Contracture
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
post burn flexion contractures release under tourniquet control
post burn flexion contractures release using tumescent solution
Contracture release and application of FTSG
Sponsored by
About this trial
This is an interventional treatment trial for Hand Burns focused on measuring burn, hand, flexion contracture, tourniquet, tumescent technique, children
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Tourniquet Group
Tumescent technique group
Arm Description
Post burn flexion contractures will be released under tourniquet control
Post burn flexion contractures will be released using Tumescent solution
Outcomes
Primary Outcome Measures
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
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.
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
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02501720
First Posted
July 12, 2015
Last Updated
July 16, 2015
Sponsor
King Edward Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02501720
Brief Title
Comparison of Outcome of Post Burn Flexion Contracture Release Under Tourniquet Verses Tumescent Technique in Children
Official Title
Comparison of Outcome of Post Burn Flexion Contracture Release Under Tourniquet Verses Tumescent Technique in Children
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Edward Medical University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Burns, Flexion Contracture
Keywords
burn, hand, flexion contracture, tourniquet, tumescent technique, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tourniquet Group
Arm Type
Active Comparator
Arm Description
Post burn flexion contractures will be released under tourniquet control
Arm Title
Tumescent technique group
Arm Type
Experimental
Arm Description
Post burn flexion contractures will be released using Tumescent solution
Intervention Type
Procedure
Intervention Name(s)
post burn flexion contractures release under tourniquet control
Intervention Description
post burn flexion contractures will be released under tourniquet control
Intervention Type
Procedure
Intervention Name(s)
post burn flexion contractures release using tumescent solution
Intervention Description
post burn flexion contractures will be released using tumescent solution
Intervention Type
Procedure
Intervention Name(s)
Contracture release and application of FTSG
Intervention Description
Post burn flexion contractures will be released and full thickness skin graft(FTSG) will be applied.
Primary Outcome Measure Information:
Title
Operative time to secure graft
Description
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 Frame
Time of surgery
Title
Percentage graft taken
Description
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.
Time Frame
14th day post surgery
Title
Post-operative pain (FLACC scale)
Description
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
Time Frame
At First hour after arrival in ward following surgery
Title
Post-operative pain (FLACC scale)
Description
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.
Time Frame
At 6th hour after arrival in ward following surgery
Title
Post-operative pain (FLACC scale)
Description
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.
Time Frame
At 12th hour after arrival in ward following surgery
Title
Post-operative pain (FLACC scale)
Description
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.
Time Frame
At 24th hour after arrival in ward following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad M Bashir, F.C.P.S
Phone
923336517745
Email
mmbashir1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Omer Iqbal, M.B.B.S
Phone
923336871707
Email
umar_doc@hotmail.com
12. IPD Sharing Statement
Citations:
Citation
Spuy L. Complications of arterial tourniquet. South Afr J Anaesth Analg. 2012; 18: 14-18.
Results Reference
background
PubMed Identifier
25075350
Citation
Lalonde D, Martin A. Tumescent local anesthesia for hand surgery: improved results, cost effectiveness, and wide-awake patient satisfaction. Arch Plast Surg. 2014 Jul;41(4):312-6. doi: 10.5999/aps.2014.41.4.312. Epub 2014 Jul 15.
Results Reference
background
PubMed Identifier
24286736
Citation
Lalonde D. Minimally invasive anesthesia in wide awake hand surgery. Hand Clin. 2014 Feb;30(1):1-6. doi: 10.1016/j.hcl.2013.08.015. Epub 2013 Nov 9.
Results Reference
background
PubMed Identifier
23348603
Citation
Teo I, Lam W, Muthayya P, Steele K, Alexander S, Miller G. Patients' perspective of wide-awake hand surgery--100 consecutive cases. J Hand Surg Eur Vol. 2013 Nov;38(9):992-9. doi: 10.1177/1753193412475241. Epub 2013 Jan 24.
Results Reference
background
PubMed Identifier
25289343
Citation
Al Youha S, Lalonde DH. Update/Review: changing of use of local anesthesia in the hand. Plast Reconstr Surg Glob Open. 2014 Jun 6;2(5):e150. doi: 10.1097/GOX.0000000000000095. eCollection 2014 May.
Results Reference
background
PubMed Identifier
23533019
Citation
Prasetyono TO. Tourniquet-Free Hand Surgery Using the One-per-Mil Tumescent Technique. Arch Plast Surg. 2013 Mar;40(2):129-33. doi: 10.5999/aps.2013.40.2.129. Epub 2013 Mar 11.
Results Reference
background
Citation
Shridharani S, Manson P, Magarakis M et al. The safety and efficacy of epinephrine in hand surgery: a systematic review of the literature and international survey. European Journal of Plastic Surgery. 2014; 37: 183-188.
Results Reference
background
PubMed Identifier
22396674
Citation
Gumus N. Tumescent infiltration of lidocaine and adrenaline for burn surgery. Ann Burns Fire Disasters. 2011 Sep 30;24(3):144-8.
Results Reference
background
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Comparison of Outcome of Post Burn Flexion Contracture Release Under Tourniquet Verses Tumescent Technique in Children
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