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

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ClinicalTrials.gov Identifier: NCT02501720
Recruitment Status : Unknown
Verified July 2015 by Muhammad Mustehsan Bashir, King Edward Medical University.
Recruitment status was:  Not yet recruiting
First Posted : July 17, 2015
Last Update Posted : July 17, 2015
Sponsor:
Information provided by (Responsible Party):
Muhammad Mustehsan Bashir, King Edward Medical University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

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.




Primary Outcome Measures :
  1. 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


  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501720


Contacts
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Contact: Muhammad M Bashir, F.C.P.S 923336517745 mmbashir1@gmail.com
Contact: Omer Iqbal, M.B.B.S 923336871707 umar_doc@hotmail.com

Sponsors and Collaborators
King Edward Medical University
Publications:
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Responsible Party: Muhammad Mustehsan Bashir, Associate professor of Plastic Surgery, King Edward Medical University
ClinicalTrials.gov Identifier: NCT02501720    
Other Study ID Numbers: 2335
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015
Keywords provided by Muhammad Mustehsan Bashir, King Edward Medical University:
burn
hand
flexion contracture
tourniquet
tumescent technique
children
Additional relevant MeSH terms:
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Contracture
Burns
Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases