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) studied | Split-thickness skin graft donor-site |
| Date of first enrollment | 11/05/2026 |
| Target sample size | 40 |
| Countries of recruitment | |
| Study type | Interventional |
| 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 Outcome | Re-epithelialization rate at 14 days post operation |
|---|---|
| Secondary Outcome | 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 |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include 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. |
| Exclude 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 |
Related Information
| Primary Sponsor | Imai Yoshimichi |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Shinyo Ishi |
| Address | 1-1 Seiryo-machi,Aoba-ku,Sendai,Miyagi Miyagi Japan 980-8574 |
| Telephone | +81-22-717-7000 |
| 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 |
| yoshimichi.imai.d6@tohoku.ac.jp | |
| Affiliation | Tohoku University Hospital |