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JRCT ID: jRCTs022250060

Registered date:27/03/2026

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedSplit-thickness skin graft donor-site
Date of first enrollment11/05/2026
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)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 graft donor-site and Beschitin to the remaining 50%, arranging them in a random order either cephalad or caudally. Cover the upper layer with gauze. (The application position is determined by random assignment using a random number table.)

Outcome(s)

Primary OutcomeRe-epithelialization rate at 14 days post operation
Secondary OutcomePPS (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

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1) 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.
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Shinyo Ishi
Address 1-1 Seiryo-machi,Aoba-ku,Sendai,Miyagi Miyagi Japan 980-8574
Telephone +81-22-717-7000
E-mail shinyo.ishi.e5@tohoku.ac.jp
Affiliation Tohoku University Hospital
Scientific contact
Name Yoshimichi Imai
Address 1-1 Seiryo-machi,Aoba-ku,Sendai,Miyagi Miyagi Japan 980-8574
Telephone +81-22-717-7000
E-mail yoshimichi.imai.d6@tohoku.ac.jp
Affiliation Tohoku University Hospital