A Comparative Clinical Trial Evaluating the Efficacy of ATK Pad, an Osmotic Absorbent Wound Dressing, for Split Thickness Skin Graft Donor Site

A Comparative Clinical Trial Evaluating the Efficacy of ATK Pad, an Osmotic Absorbent Wound Dressing, for Split Thickness Skin Graft Donor Site - ATK Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs022250060

Enrollment

Registered

2026-03-27

Start date

2026-05-11

Completion date

Unknown

Last updated

2026-06-29

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

Interventions

After harvesting split-thickness skin grafts from the thigh, achieve hemostasis using epinephrine-impregnated gauze. Once hemostasis is confirmed, apply ATK pad to 50% of the split-thickness skin graf

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Individuals for whom written consent has been obtained from the subject or their legal representative regarding participation in the study 2) Males and females aged 18 years or older at the time consent was obtained 3) Individuals from whom skin grafts are harvested from the thigh for use in split-thickness skin grafting to treat skin defects resulting from trauma (including burns), malignant tumors, infections, or other conditions requiring treatment. The conditions for skin graft harvesting are as follows: Thickness: Approximately 0.1 to 0.5 mm Width: Within approximately 10 cm Length: Within 30 cm Note: Even if skin is harvested from multiple sites, the study will be conducted on only one site.

Exclusion criteria

Exclusion criteria: 1) Individuals with allergies to the wound dressing materials used in this study 2) Individuals who cannot accurately follow a doctor's instructions 3) Individuals who are pregnant or breastfeeding 4) Individuals deemed unsuitable for inclusion in the study by the principal investigator or sub-investigator

Design outcomes

Primary

Measure	Time frame
Re-epithelialization rate at 14 days post operation	—

Secondary

Measure	Time frame
PPS (Per Protocol Set) protocol compliance cases only Days required for complete epithelialization Pain: Assess pain at 7 days, 14 days, and 1 month postoperatively using VAS score Scarring: Assess scarring at 3 months and 6 months postoperatively using a scar assessment scale Infection rate: Percentage showing signs of infection such as wound redness or pus discharge Stratified analysis of healing-inhibiting factors: Perform stratified analysis for all evaluation items based on steroid use and diabetic status Adverse events Reasons for discontinuation	—

Measure

Time frame

PPS (Per Protocol Set) protocol compliance cases only Days required for complete epithelialization Pain: Assess pain at 7 days, 14 days, and 1 month postoperatively using VAS score Scarring: Assess scarring at 3 months and 6 months postoperatively using a scar assessment scale Infection rate: Percentage showing signs of infection such as wound redness or pus discharge Stratified analysis of healing-inhibiting factors: Perform stratified analysis for all evaluation items based on steroid use and diabetic status Adverse events Reasons for discontinuation

—

Contacts

Public ContactShinyo Ishi

Tohoku University Hospital

shinyo.ishi.e5@tohoku.ac.jp+81-22-717-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026