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Comparing Modified Polyurethane Film vs. Paraffin Impregnated Gauze for Donor Site Skin Graft Healing: A Randomized Controlled Trial

Comparing Modified Polyurethane Film vs. Paraffin Impregnated Gauze for Donor Site Skin Graft Healing: A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250824002
Enrollment
62
Registered
2025-08-24
Start date
2025-07-20
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

Head and neck cancer patient with underwent reconstruction surgery with requiring antero-lateral thigh split-thickness skin graft Head and Neck cancer, reconstruction, split-thickness skin graft , STSG

Interventions

1 cm apart on perforated polyurethane film with leaving a 5-cm adhesive border around the donor site,meshed paraffin impregnated gauze covering with 0.9% NSS-soaked gauze
Experimental Device,Active Comparator Device
modified polyurethane film STSG wound dressing,paraffin impregnated gauze STSG wound dressing

Sponsors

Faculty of Medicine, Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age: 20-80 years-old 2. Diagnosed with head and neck cancer. 3. Underwent reconstruction surgery with split-thickness skin graft with donor site at antero-lateral thigh.

Exclusion criteria

Exclusion criteria: 1. Systemic disease: poor controlled DM, ESRD, liver cirrhosis, on glucocorticoid drug etc. 2. Coagulopathy patient with history of using anticoagulant/antiplatelet drug before surgery 1-7 day. 3. Malnutrition: BMI < 18.5 kg/m2 4. Patient who has history of irradiation at thigh. 5. Patient who denied operative treatment with consent.

Design outcomes

Primary

MeasureTime frame
Epithelialization of donor site split-thickness skin graft wound post-operative day 14 measure area by professional otolaryngologist

Secondary

MeasureTime frame
pain score (resting and at the time of dressing removal) post-operative day 3,5,7,10,14 visual analog scale,complication during admission until post-operative day 14 binary outcome : present or not

Countries

Thailand

Contacts

Public ContactWeerachai Watcharatsiriyuth

Faculty of Medicine, Chiang Mai University

weerachai.w@cmu.ac.th053935569

Outcome results

None listed

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