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

NCT02501720 | Unknown DMC

• 1 other identifier: 2335
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hand Burns; Flexion Contracture

Keywords

burn; hand; flexion contracture; tourniquet; tumescent technique; children

Outcome Measures

Primary Outcomes (6)

• 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

  Time of surgery

• 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.

  14th day post surgery

• 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

  At First hour after arrival in ward following surgery

• 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.

  At 6th hour after arrival in ward following surgery

• 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.

  At 12th hour after arrival in ward following surgery

• 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.

  At 24th hour after arrival in ward following surgery

Study Arms (2)

Tourniquet Group

ACTIVE COMPARATOR

Post burn flexion contractures will be released under tourniquet control

Procedure: post burn flexion contractures release under tourniquet control; Procedure: Contracture release and application of FTSG

Tumescent technique group

EXPERIMENTAL

Post burn flexion contractures will be released using Tumescent solution

Procedure: post burn flexion contractures release using tumescent solution; Procedure: Contracture release and application of FTSG

Interventions

post burn flexion contractures release under tourniquet control PROCEDURE

post burn flexion contractures will be released under tourniquet control

Tourniquet Group

post burn flexion contractures release using tumescent solution PROCEDURE

post burn flexion contractures will be released using tumescent solution

Tumescent technique group

Contracture release and application of FTSG PROCEDURE

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

Tourniquet Group; Tumescent technique group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Edward Medical University: lead

Related Publications (8)

• Spuy L. Complications of arterial tourniquet. South Afr J Anaesth Analg. 2012; 18: 14-18.

  BACKGROUND

• 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.

  PMID: 25075350 BACKGROUND

• 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.

  PMID: 24286736 BACKGROUND

• 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.

  PMID: 23348603 BACKGROUND

• 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.

  PMID: 25289343 BACKGROUND

• 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.

  PMID: 23533019 BACKGROUND

• 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.

  BACKGROUND

• Gumus N. Tumescent infiltration of lidocaine and adrenaline for burn surgery. Ann Burns Fire Disasters. 2011 Sep 30;24(3):144-8.

  PMID: 22396674 BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Muhammad M Bashir, F.C.P.S

CONTACT

923336517745; mmbashir1@gmail.com

Omer Iqbal, M.B.B.S

CONTACT

923336871707; umar_doc@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Plastic Surgery

Study Record Dates

• First Submitted: July 12, 2015
• First Posted: July 17, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 17, 2015

Record last verified: 2015-07