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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
King Edward Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

3 Years - 12 Years (Child)All SexesDoes not accept 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.

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

    First Posted
    July 12, 2015
    Last Updated
    July 16, 2015
    Sponsor
    King Edward Medical University
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    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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