None listed
Conditions
Brief summary
This study aims to compare the clarity of operative field and final functional outcome created by non-tourniquet technique using one-per-mil tumescent technique and pneumatic tourniquet in postburn hand contracture surgery. In this study, the subjects will be randomly allocated into two groups; one-per-mil tumescent group and tourniquet group. Both group will undergo similar contracture release surgery, except the surgery preparation to stop or reduce the bleeding conducted at the beginning of the surgery. One group will be prepared using one-per-mil tumescent technique. The surgery sites will be injected with one-per-mil tumescent solution which consists of epinephrine (vasoconstrictive agent), lidocaine (analgetic agent), and normal saline until the skin turns pale. The other group will be prepared using tourniquet. It is expected that one-per-mil tumescent technique is as effective as tourniquet to create clear operative field in postburn hand contracture surgery and eventually the final functional outcome in both groups will be similar.
Interventions
One-per-mil tumescent technique.
Before the surgery begins, the subjects in one-per-mil tumescent group will be injected subcutaneously with one-per-mil tumescent solution which consists of 1:1,000,000 epinephrine and lidocaine 0.2% in saline solution (NaCl 0.9%). The solution will be injected into the surgical sites using 26G needle and 1 mL syringe until the skin blanches (becomes pale). Single surgeon (principal investigator) will perform all the procedures. The injection will be given one ti
One-per-mil tumescent technique. Before the surgery begins, the subjects in one-per-mil tumescent group will be injected subcutaneously with one-per-mil tumescent solution which consists of 1:1,000,000 epinephrine and lidocaine 0.2% in saline solution (NaCl 0.9%). The solution will be injected into the surgical sites using 26G needle and 1 mL syringe until the skin blanches (becomes pale). Single surgeon (principal investigator) will perform all the procedures. The injection will be given one time only, 25 minutes prior to first incision. The amount of injected solution will be recorded in the case report form.
Sponsors
Theddeus Octavianus Hari Prasetyono, MD, PhD
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
- Patients aged 5-65 years, who are otherwise healthy, with post-burn hand deformity who will undergo contracture release in Cipto Mangunkusumo Hospital, Jakarta, Indonesia - Patients who give informed consent to participate in the research
Exclusion criteria
- Patients with hematologic disorders, peripheral vascular disorders, diabetes mellitus, hypertension, liver diseases, and rheumatic diseases - Patients who are smoking except those who are willing to stop the smoking habit for at least two weeks before surgery - Patients who consume anti-coagulant or anti-thrombotic medications, such as heparin, aspirin, clopidogrel, and warfarin
Outcome results
None listed