Pain Delayed wound healing Infection Scarring Split-thickness skin graft donor sites. Split thickness skin graft Donor site Wound healing Pain management Tranexamic acid Adrenaline Bupivacaine Hydrogel Silver dressing Randomized controlled trial
Conditions
Interventions
TAB hydrogel is prepared by mixing tranexamic acid 100 mg per mL, adrenaline 1 to 100000, and bupivacaine 0.5 percent in equal volume with DuoDERM Hydroactive Gel at a 1 to 1 ratio under sterile condi
Tranexamic acid, Adrenaline, and Bupivacaine Hydrogel (TAB Hydrogel),Silver-containing FoamDressing
Sponsors
Nakornping Hospital, Chiang Mai, Thailand
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients requiring split-thickness skin grafting with at least two donor sites of at least 5 cm width and 10 cm length per site 2. Ability to provide informed consent 3. Ability to independently evaluate pain scores 4. Agreement to participate in the full duration of the study protocol
Exclusion criteria
Exclusion criteria: 1. Inability to communicate pain levels effectively 2. Known allergy to Tranexamic acid, Adrenaline, Bupivacaine, or any component of DuoDERM Hydroactive Gel 3. Bilateral thigh wounds or burns 4. Total body surface area burned greater than 40% 5. Pregnant or lactating women 6. Patients receiving chemotherapy, immunosuppressants, steroids, DMARDs, anticoagulants, or antiplatelet drugs 7. Severe coexisting conditions such as end-stage heart failure, uncontrolled bleeding disorders, poorly controlled diabetes mellitus (fasting blood glucose greater than 250 mg/dL or HbA1C greater than 9%) or uncontrolled hypertension 8. Liver cirrhosis above Child-Pugh class A or chronic alcoholism 9. BMI greater than 30 kg/m2 10. Patients unable to comply with the study protocol 11. Participation in another clinical trial within 30 days before enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain score during postoperative period Daily during the first 5 days after surgery Visual Analog Scale (VAS), assessed three times per day by trained nurse | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound epithelialization rate At day 10, day 15, and day 22 after skin grafting Clinical assessment by direct observation and photography, reviewed by blinded surgeon,Scar quality At 3 and 6 months after skin grafting Vancouver Scar Scale | — |
Countries
Thailand
Contacts
Public ContactPattana Ongkasuwan
Department of Surgery, Nakornping Hospital, Chiang Mai, Thailand
Outcome results
None listed