Hand BurnsNCT02501720
Comparison of Outcome of Post Burn Flexion Contracture Release Under Tourniquet Verses Tumescent Technique in Children
A study testing post burn flexion contractures release using tumescent solution and Contracture release and application of FTSG in people with Hand Burns and Flexion Contracture, run by King Edward Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Hand Burns, Flexion Contracture
- What is being tested?
- post burn flexion contractures release using tumescent solution and Contracture release and application of FTSG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Hand Burns, Flexion Contracture
- Being tested
- post burn flexion contractures release under tourniquet control, post burn flexion contractures release using tumescent solution, Contracture release and application of FTSG
- Keywords
- burn, hand, flexion contracture, tourniquet, tumescent technique, children
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post burn flexion contractures release under tourniquet controlProcedure or surgery
post burn flexion contractures will be released under tourniquet control
post burn flexion contractures release using tumescent solutionProcedure or surgery
post burn flexion contractures will be released using tumescent solution
Contracture release and application of FTSGProcedure or surgery
Post burn flexion contractures will be released and full thickness skin graft(FTSG) will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet Group | Active comparator | Post burn flexion contractures will be released under tourniquet control Receives: 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 Receives: Procedure: post burn flexion contractures release using tumescent solution; Procedure: Contracture release and application of FTSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 24th hour after arrival in ward following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hand BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Mustehsan Bashir, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501720
- Sponsor's protocol ID
- 2335
- Status last verified
- Jul 2015
- First submitted
- 12 Jul 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Spuy L. Complications of arterial tourniquet. South Afr J Anaesth Analg. 2012; 18: 14-18.
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.
PubMed 25075350Lalonde 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.
PubMed 24286736Teo 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.
PubMed 23348603Al 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.
PubMed 25289343Prasetyono 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.
PubMed 23533019Shridharani 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.
Gumus N. Tumescent infiltration of lidocaine and adrenaline for burn surgery. Ann Burns Fire Disasters. 2011 Sep 30;24(3):144-8.
PubMed 22396674
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome of Post Burn Flexion Contracture Release Under Tourniquet Verses Tumescent Technique in Children
- ClinicalTrials.gov ID
- NCT02501720
- Acronym / sponsor ID
- 2335
- Conditions
- Hand Burns, Flexion Contracture
- Keywords
- burn, hand, flexion contracture, tourniquet, tumescent technique, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tourniquet Group | Active comparator | Procedure: post burn flexion contractures release under tourniquet control, Procedure: Contracture release and application of FTSGPost burn flexion contractures will be released under tourniquet control |
| Tumescent technique group | Experimental | Procedure: post burn flexion contractures release using tumescent solution, Procedure: Contracture release and application of FTSGPost burn flexion contractures will be released using Tumescent solution |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| post burn flexion contractures release under tourniquet controlpost burn flexion contractures will be released under tourniquet control | Procedure or surgery | Tourniquet Group |
| post burn flexion contractures release using tumescent solutionpost burn flexion contractures will be released using tumescent solution | Procedure or surgery | Tumescent technique group |
| Contracture release and application of FTSGPost burn flexion contractures will be released and full thickness skin graft(FTSG) will be applied. | Procedure or surgery | Tourniquet Group, Tumescent technique group |
Primary outcome
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
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.
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
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
- BackgroundSpuy L. Complications of arterial tourniquet. South Afr J Anaesth Analg. 2012; 18: 14-18.
- Background: PubMed 25075350Lalonde 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.
- Background: PubMed 24286736Lalonde 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.
- Background: PubMed 23348603Teo 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.
- Background: PubMed 25289343Al 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.
- Background: PubMed 23533019Prasetyono 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.
- BackgroundShridharani 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: PubMed 22396674Gumus N. Tumescent infiltration of lidocaine and adrenaline for burn surgery. Ann Burns Fire Disasters. 2011 Sep 30;24(3):144-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing post burn flexion contractures release using tumescent solution and Contracture release and application of FTSG in people with Hand Burns and Flexion Contracture, run by King Edward Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad M Bashir, F.C.P.S (923336517745, mmbashir1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time to secure graft (time frame: Time of surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02501720, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2015.