Skip to content

Topical Tranexamic Acid, Adrenaline, and Bupivacaine Solution for Pain Management and Healing in Split-Thickness Skin Graft Donor Sites: An Open-Label Interventional Study with Randomized Side Allocation

Efficacy of a Mixed Solution of Tranexamic acid, Adrenaline and Bupivacaine in Donor Split Thickness Skin Graft: A Pilot Crossover Study

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250208007
Enrollment
12
Registered
2025-02-08
Start date
2023-05-23
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Split-thickness skin graft donor site wounds are a common concern in reconstructive surgery, often associated with severe pain, delayed wound healing, and scarring. These wounds occur in patients undergoing skin grafting for burns, traumatic injuries, chronic ulcers, or surgical reconstruction. Effective management is essential to reduce pain, promote faster healing, and improve scar quality. Current treatments, such as paraffin-chlorhexidine gauze dressings, have limitations, including poor pai

Interventions

The topical TAB solution was prepared fresh for each patient by combining tranexamic acid, adrenaline, and bupivacaine under sterile conditions. ,Standard treatment sites received soft paraffin with c
TAB Solution,ST

Sponsors

Nakornping Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients scheduled for split-thickness skin grafting 2. Patients with acute or chronic wounds requiring skin grafting 3. Patients able to provide informed consent 4. Patients with two donor sites of comparable size for intra-individual comparison 5. Patients with stable vital signs and hemodynamic status before surgery 6. Patients without contraindications to local anesthetics, hemostatic agents, or vasoconstrictors 7. Patients willing to comply with the study protocol, including follow-up assessments

Exclusion criteria

Exclusion criteria: 1. Known allergies to solution components 2. Pregnancy 3. Severe comorbidities (advanced heart failure, coagulopathy) 4. Type 2 diabetes with fasting blood glucose exceeding 250 mg/dL or HbA1C above 9% 5. Cirrhosis beyond Child A stage 6. Body mass index above 30 7. Inability to comply with the study protocol

Design outcomes

Primary

MeasureTime frame
Pain Intensity 24, 48, 72, and 120 hours post-surgery Visual Analog Scale (VAS, 0-10) Visual Analog Scale (VAS, 0-10),Epithelialization Rate Days 10-14 post-surgery Digital photography analysis,Time to Complete Healing Measured until full epithelialization Number of days from surgery to 100 percent epithelialization

Secondary

MeasureTime frame
Hemodynamic Parameters Every 15 minutes for 2 hours post-application Heart rate, systolic and diastolic blood pressure using bedside monito,Scar Quality 8 weeks post-surgery Vancouver Scar Scale (VSS),Adverse Events Throughout the study period, including follow-up Standardized adverse event reporting forms

Countries

Thailand

Contacts

Public ContactPattana Ongkasuwan

Nakornping Hospital

had.pattana@gmail.com66819525912

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026