Safety Study of Microlyte DualGuard (SAGGA)
2026년 7월 6일 업데이트: Imbed Biosciences
Feasibility Clinical Trial to Assess the Safety and Potential Effectiveness of Microlyte® DualGuard Wound Dressing on Surgically Created Partial-thickness Donor Site Wounds on Patients Requiring Split- Thickness Skin Grafting; the SAGGA Trial
The primary purpose of this research is to evaluate the safety and effectiveness of Microlyte® DualGuard wound dressing in the healing of partial thickness donor site wounds, also known as skin graft donor sites.
This research will assess wound healing, the occurrence of infection, allergic reaction, pain, and itching while subjects are in the hospital and after discharge.
Subjects will complete clinic visits through 12 weeks.
This research will also assess the occurrence of donor site wound infection, pain and itching, and scarring at 12 weeks, assessed by subjects using the Patient and Observer Scar Assessment Scale (POSAS).
연구 개요
상태
아직 모집하지 않음
상세 설명
This study is a multi-center randomized, controlled, open-label, split-wound clinical trial to assess the safety and potential effectiveness in wound healing of the Microlyte® DualGuard wound dressing in surgically created partial-thickness donor site wounds (DSW) on patients requiring split-thickness skin grafting.
This clinical trial is designed to demonstrate safety and effectiveness of the Microlyte® DualGuard wound dressing. We note that this clinical trial is designed for the management of surgically created clean acute donor-site wounds. These surgically clean acute wounds have high tendency to heal with the standard of care if supervised diligently, especially under the monitoring of a clinical trial.
Donor site wounds are created regularly in surgical hospitals as a means to utilize split-thickness skin grafts for closure of chronic, traumatic, infectious, oncologic, burn and other wounds. A donor site wound is a reproducible partial thickness wound. At the same time, it is associated with morbidity including pain, long healing times, risk of infection, and long-term cosmetic changes. Thus, it is the ideal model for assessment of safety and effectiveness of topical products engineered for wound healing and infection control. The donor site can easily be divided into two halves that are amenable to randomization using intra-patient controls to maximize the chances of assessing safety and effectiveness.
연구 유형
중재적
등록 (추정된)
53
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Brad Wiggins, BSN, RN, CBRN
- 전화번호: 888-472-9898
- 이메일: bwiggins@imbedbio.com
연구 연락처 백업
- 이름: Carrie M Huffman, MA, MPH, DLP, RAC-US
- 전화번호: 301-337-8159
- 이메일: chuffman@imbedbio.com
연구 장소
-
-
Arizona
-
Phoenix, Arizona, 미국, 85008
- Valleywise Health Medical Center
-
연락하다:
- Lora Nordstrom, PHD, BSN, CCRC, CHRC
- 전화번호: 602-344-2759
- 이메일: lora.nordstrom@valleywisehealth.org
-
수석 연구원:
- Kevin Foster, MD, MBA, FACS
-
-
District of Columbia
-
Washington D.C., District of Columbia, 미국, 20010
- MedStar Washington Hospital Center
-
연락하다:
- Melissa McLawhorn, RN, BSN
- 전화번호: 202-877-6181
- 이메일: melissa.m.mclawhorn@medstar.net
-
수석 연구원:
- Jeffrey W Shupp, MD
-
-
Louisiana
-
New Orleans, Louisiana, 미국, 70112
- University Medical Center New Orleans, LSU Health NOLA
-
연락하다:
- Shana Lennard, RN, BSN, CCRP
- 전화번호: 504-702-5171
- 이메일: slenna@lsuhsc.edu
-
수석 연구원:
- Jeffrey E Carter, MD, FACS, FABA
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Adult patients where creation of a donor site wound for any indication including chronic wound, burn wound, surgical/traumatic wound, and tumor excision is indicated.
- Thigh donor site wound (DSW) location.
- At least 22 years of age.
- Ability to understand and provide a signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for all visits for the duration of the study.
- All female subjects of childbearing potential (not surgically sterile or postmenopausal) and male subjects with female partners of childbearing potential must agree to use effective contraception (such as implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study (84 days).
- Fitzpatrick Skin Type (FST I-VI) assessment and documentation at baseline. Subjects of all FST categories (I-VI) are eligible, and the enrollment strategy will ensure that the full range of FST is represented in the study population (10% minimum enrollment in each FST sub-category).
Exclusion Criteria:
- DSW size of > 310 cm2
- Calculated glomerular filtration rate (GFR) <60 ml/min
- Hypocalcemia defined as serum corrected calcium of <8.0 mg/dl
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the upper limit of normal (ULN).
- Serum Creatinine > 2.0 mg/dL.
- Pregnant, lactating or nursing women.
- Unable to provide consent.
- Prior adverse reaction or known sensitivity to silver or gallium.
- Enrollment in another interventional trial using a systemic therapeutic within 30 days prior to enrollment for this study.
- Presumed impairment of wound healing as with prescription drugs or medical diagnoses that have potential to impair wound healing at the discretion of clinical investigator, e.g., cancer, transplant status, autoimmune disease, severe malnutrition, etc.
- Any diagnosis with concern for 30-Day mortality.
- Any condition that might impair the evaluation of subject safety or that in the investigator opinion would interfere with study requirements.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Treatment Arm - Proximal or Distal DSW location
Treatment with Microlyte DualGuard (investigational device)
|
Microlyte® DualGuard wound dressing: It is a sterile, single use synthetic polyvinyl alcohol absorbent sheet with ionic gallium, and with a polymeric surface coating containing ionic and metallic silver.
It has very low amounts of silver and gallium with maximum of 0.16 mg/sq.
in.
and 1 mg/sq.
in., respectively.
Microlyte® DualGuard wound dressing absorbs wound fluid and forms a soft gel that conforms to the wound surface and maintains a moist environment.
The dressing contains silver and gallium only to prevent or minimize microbial growth within the dressing.
|
|
활성 비교기: Standard of Care Arm - opposite side of DSW from treatment arm
The DSW will have a side (proximal or distal) that is randomized to Microlyte DualGuard.
The opposite side (proximal or distal) will be treated with standard of care foam dressing (Allevyn).
|
Allevyn® is indicated for as wound management by secondary intention on shallow, granulating wounds, chronic and acute exuding wounds, full- and partial-thickness wounds including: leg ulcers, diabetic foot ulcers, surgical wounds, first- and second-degree burns, skin graft donor site, skin tears, and pressure injuries.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Incidence of wound closure defined as skin re-epithelialization without drainage or dressing requirements, confirmed at two consecutive study visits 2 weeks apart (Day 14 and Day 28)
기간: From enrollment to Day 84
|
From enrollment to Day 84
|
|
Adverse event occurrence, including infection
기간: From enrollment to Day 84
|
From enrollment to Day 84
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Debridement - yes or no
기간: Enrollment to Day 84
|
Enrollment to Day 84
|
|
Pain as measured using a 10-point VAS
기간: Enrollment to Day 84
|
Enrollment to Day 84
|
|
Itching as assessed using a 10-point VAS
기간: Enrollment to Day 84
|
Enrollment to Day 84
|
|
Time, in days, to complete DSW closure
기간: Enrollment to Day 84
|
Enrollment to Day 84
|
|
Percentage of donor site wound closure at Day 9
기간: Enrollment to Day 9
|
Enrollment to Day 9
|
|
Quality of healing, evaluated using the Patient Observer Scare Assessment Scale (POSAS)
기간: Day 84
|
Day 84
|
|
Durability of wound closure at 12 weeks
기간: Day 84
|
Day 84
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Kevin Foster, MD, MBA, FACS, Valleywise Health Medical Center
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 30일
기본 완료 (추정된)
2027년 4월 1일
연구 완료 (추정된)
2027년 8월 1일
연구 등록 날짜
최초 제출
2026년 7월 6일
QC 기준을 충족하는 최초 제출
2026년 7월 6일
처음 게시됨 (실제)
2026년 7월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 6일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- ID MIDRP 01
- W81XWH-15-9-0001 (기타 식별자: Department of Defense)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .