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

K

King Edward Medical University

Status

Unknown

Conditions

Flexion Contracture
Hand Burns

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

3 to 12 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Tourniquet Group
Active Comparator group
Description:
Post burn flexion contractures will be released under tourniquet control
Treatment:
Procedure: Contracture release and application of FTSG
Procedure: post burn flexion contractures release under tourniquet control
Tumescent technique group
Experimental group
Description:
Post burn flexion contractures will be released using Tumescent solution
Treatment:
Procedure: Contracture release and application of FTSG
Procedure: post burn flexion contractures release using tumescent solution

Trial contacts and locations

0

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Central trial contact

Omer Iqbal, M.B.B.S; Muhammad M Bashir, F.C.P.S

Data sourced from clinicaltrials.gov

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