Application of HD AM to Refractory skin ulcer and the emergency field

Phase 1

Recruiting

• Conditions: Regeneration of Skin, Refractory skin ulcer, Open wound of the abdominal wall

• Registration Number: JPRN-jRCTs042220007
• Lead Sponsor: Shimizu Tadamichi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-25
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

[Regeneration of Skin on severe burns of large necrotic tissue resection site]
1) Age:Patients over 18 years old (at the time of obtaining informed consent)
2)Severe burns that may require necrotic tissue resection (debridement) and subsequent skin grafting, such as wounds that are Depth II degree burn and Depth III degree burn.
3)Patients who are judged to be able to observe / inspect and investigate according to the research implementation plan.
4)Patients (the subjects) who have been able to understand the written explanation and who have agreed voluntarily. If the subject have been disagreeable consciousness, informed consent will be obtained from the proxy based on the Clinical Research Law. In this case, the proxy has been,

[Refractory skin ulcer]
1)Age:Patients over 18 years old (at the time of obtaining informed consent)
2)Patients who are judged to have difficulty in wound closure during the acute phase (within 2 weeks).
3)Intractable cutaneous ulcers that may require necrotic tissue resection (debridement) and subsequent skin grafting, such as wounds that are Ischemic ulcers, vein static ulcers, collagen disease related ulcers, diabetic ulcers, vasculitis ulcers, after radiation treatment ulcers, trauma, burns and doner site in skin grafting.
4)Patients who are judged to be able to observe / inspect and investigate according to the research implementation plan.
5)Patients (the subjects) who have been able to understand the written explanation and who have agreed voluntarily based on the Clinical Research Law.

[Open wound that is difficult to close with exposed intestinal tract]
1)Age:Patients over 18 years old (at the time of obtaining informed consent)
2)Patients with difficulty in abdominal wall closure during the acute phase (within 2 weeks)
3)Patients who have undergone laparotomy due to abdominal trauma, intra-abdominal infection, acute pancreatitis, intestinal ischemia, abdominal compartment syndrome, etc. and cannot close the abdomen after surgery.
4)Patients who are judged to be able to observe / inspect and investigate according to the research implementation plan.
5))Patients (the subjects) who have been able to understand the written explanation and who have agreed voluntarily. When obtaining the consent of a surrogate in accordance with the Clinical Research Act if the subject is in a conscious state where the consent of the subject himself/herself cannot be obtained.
In this case, the proxy has been, a spouse, a guardian, or any other similar person, and has been considered to be able to represent the patient's will and interests in view of the substance and spiritual relationship.

Exclusion Criteria

[Regeneration of Skin on severe burns of large necrotic tissue resection site]
1)Patients whose doctors have judged that it is difficult to keep safe wound management throughout the study period.
2)Patients with active infections.
3)Patients who participated in other studies or clinical studies within 6 months (However, control patients who do not use Research reproduction Medical products, etc., research drugs or c medical devices.).
4)Pregnancy or the childbearing patients who may be pregnant or hope for pregnancy during study period or do not use appropriate contraception.
5)Patients who were judged to be inadequate as an object of this study in testing at agreement acquisition by doctor.

[Refractory skin ulcer]
1)Patients whose doctors have judged that it is difficult to keep safe wound management throughout the study period.
2)Patients with active infections.
3)Patients who participated in other studies or clinical studies within 6 months (However, control patients who do not use Research reproduction Medical products, etc., research drugs or c medical devices.).
4)Pregnancy or the childbearing patients who may be pregnant or hope for pregnancy during study period or do not use appropriate contraception.
5)Patients who were judged to be inadequate as an object of this study in testing at agreement acquisition by doctor.

[Open wound that is difficult to close with exposed intestinal tract]
1)Patients with necrotic tissue or definite infection in the wound.
2)Patients who already have EAF on the exposed intestinal tract.
3)Patients determined by a doctor to have difficulty continuing safe treatment over the duration of the study.
4)Patients with active infections.
5)Patients who plan to perform other surgery on the efficacy evaluation site during the study period (the study starts with the acquisition of consent).
6)Patients who participated in other studies or clinical studies within 6 months (However, control patients who do not use Research reproduction Medical products, etc., research drugs or c medical devices.).
7)Pregnancy or the childbearing patients who may be pregnant or hope for pregnancy during study period or do not use appropriate contraception.
8)Patients who were judged to be inadequate as an object of this study in testing at agreement acquisition by doctor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified