Confirmatory clinical trial of silk-elastin sponge (P47K-WAS) for patients with skin defects

JRCT ID: jRCT2052210072

Registered date:26/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Skin wounds that conventional treatments do not work, or that it is considered that conventional tr
• Date of first enrollment: 02/08/2021
• Target sample size: 25
• Study type: Interventional

Intervention(s)

The target wound is debrided, and a P47K-WAS is applied to the surface of the wound.
After removing the residual P47K-WAS on day 14, the wound surface is evaluated.
After that, conventional treatments are performed, and the wound are observed and evaluated until 28 days after application of the P47K-WAS.

Outcome(s)

Primary Outcome

Ratio of case judged to have been in condition that it was able to close wound.
(14th day after application of the P47K-WAS)

Secondary Outcome

. Ratio of case judged to have been in condition that it was able to close wound.
(7th day,14th day (only case of acute wounds), 21st day, 28th day after application of the P47K-WAS)
. Ratio of the final wound area relative to the wound area at enrollment
. Proportion of the final wound area that was occupied by healthy granulation tissue
. Number of P47K-WAS treatments
. Questionnaire about convenience of P47K-WAS treatments

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

[Case of chronic wounds]
1. The total wound size after 4 weeks of conventional treatment was still more than 50% of the wound size at the first visit.
2. The wound area (long times short diameter) after debridement ranged from 2cm^2 to 25cm^2.
3. When the wound was covered by the P47K-WAS, it could be sealed by woun dressing.
4. When the wound was present at the same time as the target wound, there was healthy skin between the wounds.
5. There was no local infection in the wound.
6. The proportion of the area that exposed bone was <10% of the total wound area.
7. In the case of chronic wounds on the lower legs, feet, and toes, the skin perfusion pressure of the affected leg exceeded 30mm Hg.
8. Those that can be diagnosed as diabetic ulcers, venous stasis uclers, decubitus, etc. as background diseases of the wound.
[Case of acute wounds]
1. The following wounds, which had no intrinsic factors that prolong wound healing and were considered to require wound bed preparation (WBP).
Complex wound, the burn that was higher than invasion depth grade II, the local infection wound that were considered to be controllable and soothing.
2. The wound area (long times short diameter) after debridement ranged from 2cm^2 to 100cm^2.
3. When the wound was covered by the P47K-WAS, it could be sealed by wound dressing.
4. When the wound was present at the same time as the target wound, there was healthy skin between the wounds.
5. There was no local infection in the wound.
6. The proportion of the area that exposed bone was <10% of the total wound area.

Exclude criteria

1. The patient was < 20 years old when he/she consented to participate in the trial.
2. Womans that fell under any of the following.
. Women who did not consent to use contraception during the trial
. Women who were or could be pregnant
. Women who were nursing
3. Patients with previous histories of allergy against silk, urethane, and other reagents used in the trial, including anesthetics and disinfectant
4. Patients with any of the following conditions:
. Poorly controlled diabetes (>10% of HbA1c in the latest laboratory findings within 28 days before enrollment)
. Hypoalbuminemia (< 2 g/dL)
. Patient was being treated for malignancy.
. Patient required continuous systemic administration of steroids (dose exceeding an equivalent predonisolone dose of 10mg/day).
5. Patients participated in another clinical trial within 3 months before enrollment.
6. Wounds that were difficult to do decompression relief.
7. Patients participated in this trial and were administered the investigational device.
8. Patients who were not able to consent in writing to participate in the trial.
9. Patients who were considered by an investigator or sub-investigator to be inappropriate for inclusion in the trial.

Related Information

• Primary Sponsor: Kawabata Shingo