Clinical trial NCT02501720: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hand Burns
Flexion Contracture
Keywords: burn
hand
flexion contracture
tourniquet
tumescent technique
children
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Operative time to secure graft
timeFrame: Time of surgery
measure: Percentage graft taken
timeFrame: 14th day post surgery
measure: Post-operative pain (FLACC scale)
timeFrame: At First hour after arrival in ward following surgery
measure: Post-operative pain (FLACC scale)
timeFrame: At 6th hour after arrival in ward following surgery
measure: Post-operative pain (FLACC scale)
timeFrame: At 12th hour after arrival in ward following surgery
measure: Post-operative pain (FLACC scale)
timeFrame: At 24th hour after arrival in ward following surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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