Study of Tolerance to the Application of Cold Plasma in the Treatment of Chronic Wounds (PLASMA-SAFE)
Chronic wounds affect many patients, with no downward trend in recent decades. This is a significant economic and social issue, and this condition has an impact on functional disabilities and quality of life, especially among the elderly. Diagnosis is essentially clinical, and there are many causes, but 90% of leg ulcers, for example, are primarily vascular in origin. There are wounds of traumatic, post-operative, and vascular origin, as well as pressure sores. The main purpose of invasive tests is to objectively determine the cause (arterial damage) or to check for underlying osteitis. Chronic wounds are usually infected or colonized by bacteria from the skin and digestive flora. There is no indication for antibiotic therapy in the treatment of wounds. Nursing staff play an important role in therapeutic management, which must be carried out in harmony with other healthcare professionals, such as general practitioners and specialists. This management has two main goals: to accelerate the epidermalization of chronic wounds, or even their healing, and to limit local and general complications, the recurrence of which remains the most difficult to control. There are many types of healing dressings available, adapted to each type of ulceration: fibrinous, necrotic, superinfected, etc.
Nevertheless, innovative solutions can accelerate healing, thereby reducing hospital stays, disabilities associated with chronic wounds, and complications such as skin-related septicemia. Research efforts may focus on the use of growth factors, for example, for old or stubborn forms of the disease, despite proper medical treatment, or on any other innovative technique.
The properties of cold plasma appear to be suitable for the treatment of chronic wounds, as has been demonstrated in cell models, animal models, and with argon plasma in several countries around the world on an experimental basis in humans.
The GREMI in Orléans has acquired internationally recognized expertise in the technique of cold helium plasma. The combination of this applied research laboratory and the Infectious Diseases Department of the Orléans University Hospital has led to the development of relationships that have resulted in the proposal to conduct this study, based in its first phase on the evaluation of the medical device's tolerance.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Thierry PRAZUCK, PH
- 전화번호: +332 38 51 43 61
- 이메일: thierry.prazuck@chu-orleans.fr
연구 장소
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Orléans, 프랑스, 45000
- 모병
- Centre Hospitalier Universitaire d'Orléans, France
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수석 연구원:
- Thierry PRAZUCK, MD
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연락하다:
- Thierry PRAZUCK, MD
- 이메일: thierry.prazuck@chu-orleans.fr
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Men or women.
- Aged 18 years or older.
- Chronic wound or ulceration.
- Wound measuring 5 to 100 cm² of arterial or venous origin.
- Evolution > 4 weeks.
- With less than 30% necrosis.
- Able to give informed written consent.
- Blood pregnancy test for women of childbearing age.
Exclusion Criteria:
- Tumor wounds
- Dialysis
- Patients requiring surgical revascularization
- Severe heart failure (NYHA III-IV) or acute myocardial infarction.
- Wounds or ulcers located less than 10 cm from the patient's airways and respiratory tract
- Severe renal failure defined as creatinine clearance <20 mL/min calculated according to the MDRD
- Patients with severe hepatic impairment (class C) according to the Child Pugh score
- Unstable liver disease (defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormality.
- Active malignant tumor
- Patients who, in the investigator's opinion, are at significant risk of suicide
- Any pre-existing physical or mental condition that may interfere with the patient's ability to comply with the administration schedule and/or protocol assessments, or that may compromise the patient's safety.
- Persons covered by Articles L.1121-5 to L.1121-8 and L.1122-1-2 of the Public Health Code (including minors and protected adults)
- Protected person (under guardianship or curatorship)
- Person under judicial protection
- Persons deprived of their liberty
- Persons not affiliated with a social security system
- Women who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study.
- Patients participating in another clinical trial evaluating a treatment
- Allergy to the dressings used in the trial
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Plasma treatment with exposure 1 min/10 cm² + conventional treatment
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The plasma will be applied using the multi-jet probe by an investigating physician over the entire surface of the ulceration during the defined exposure times (1min/10 cm2), after which the nurse will apply the standard dressing appropriate for the characteristics of the ulceration. The sessions will be repeated daily for 8 days. |
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실험적: Plasma treatment with exposure 3 min/10 cm² + conventional treatment
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The plasma will be applied using the multi-jet probe by an investigating physician over the entire surface of the ulceration during the defined exposure times (3min/10 cm2), after which the nurse will apply the standard dressing appropriate for the characteristics of the ulceration.
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실험적: Treatment using dressings impregnated with ions induced by exposure to plasma
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The plasma will be applied using the multi-jet probe by an investigating physician over the dressing, after which the nurse will apply the dressing on the ulceration.
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간섭 없음: Conventional treatment with hydrocolloid dressing or adapted dressing, local care
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Level of local inflammation
기간: Everyday for 8 days
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Everyday for 8 days
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in the size of the ulcer
기간: Day 0, Day 2, Day 4, Day 6 and Day 7
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Measurement of the wound area using MolecuLight for daily photographies and computer analysis of the images
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Day 0, Day 2, Day 4, Day 6 and Day 7
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Change in the extent of tissue loss
기간: Day 0, Day 2, Day 4, Day 6 and Day 7
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Measuring wound volume with the MolecuLight
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Day 0, Day 2, Day 4, Day 6 and Day 7
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semi-quantitative change in total bacterial load
기간: Day 0 and day 7
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semi-quantitative change in total bacterial load between Day 0 and Day 7 on bacterial samples taken from the base of the ulcer
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Day 0 and day 7
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- CHUO-2024-03
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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