Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction
A Prospective Pilot Study of Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction
This prospective single-arm pilot study will evaluate the application of meshed 5 × 7 cm Restrata® sheets to the abdominal wall donor site following deep inferior epigastric perforator (DIEP) or abdominal wall autologous free tissue transfer in 20 eligible patients.
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: Justin Sacks, MD, MBA, FACS
- 전화번호: 314-454-4894
- 이메일: jmsacks@wustl.edu
연구 장소
-
-
Missouri
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St Louis, Missouri, 미국, 63110
- Washington University School of Medicine
-
연락하다:
- Justin Sacks, MD, MBA, FACS
- 전화번호: 314-454-4894
- 이메일: jmsacks@wustl.edu
-
수석 연구원:
- Justin Sacks, MD, MBA, FACS
-
부수사관:
- William Zhu, MD
-
부수사관:
- Terence Myckatyn, MD
-
부수사관:
- Gary Skolnick, MBA
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Scheduled for DIEP or abdominal wall autologous free tissue transfer procedure.
- At least 18 years of age.
- Karnofsky performance status ≤ 80%
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Exclusion Criteria:
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Current smoker.
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Body mass index > 39.9.
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Received systemic chemotherapy within 4 weeks prior to the scheduled DIEP or abdominal wall autologous free tissue transfer procedure.
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Uncontrolled diabetes mellitus determined by the investigator.
*Note: if there is documentation of HgbA1c > 12% within 3 months of the scheduled DIEP or abdominal wall autologous free tissue transfer procedure, it will need to be reviewed by the PI to determine the patient's clinical situation and eligibility.
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Pregnant.
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Currently receiving any investigational agents.
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Known sensitivity to resorbable sutures (polyglactin 910, polydioxanone).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Restrata® application
Patients undergoing standard of care deep inferior epigastric perforator (DIEP) or abdominal wall free tissue transfer procedure will have Restrata® sheets applied to the abdominal wall donor site following flap harvest. Patients will be followed for 12 months to assess outcomes. |
Restrata® is prepared in 5 x 7cm sheets and will be administered to the abdominal wall donor site following the flab harvest.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of post-operative seroma, hematoma formation, or wound dehiscence within 6 weeks of procedure
기간: At time of procedure to 6 weeks after procedure (total estimated time: 6 weeks)
|
Clinical assessment of seroma formation will be conducted by the investigator through evaluation of the surgical site for the presence of swelling and/or fluid wave upon exam. Clinical assessment of hematoma formation and wound dehiscence will be conducted by the investigator through evaluation of the surgical site for the presence of swelling, discoloration, and firmness to the touch upon palpitation. Wound dehiscence is defined as separation of the margins of the closed surgical incision made in the skin, with or without exposure/protrusion of underlying tissue. |
At time of procedure to 6 weeks after procedure (total estimated time: 6 weeks)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of post-operative infection
기간: At time of procedure until 3 months after procedure (total estimated time: 3 months)
|
Post-operative infection will be assessed via the occurrence of physiological symptoms including fever, pain, swelling, erythema, or seroma via clinical assessment. Post-operative infection will be summarized as absolute counts and as descriptive proportions along with corresponding 95% confidence intervals. |
At time of procedure until 3 months after procedure (total estimated time: 3 months)
|
|
Rate of post-operative wound dehiscence within 3 months of procedure
기간: At time of procedure until 3 months after procedure (total estimated time: 3 months)
|
Post-operative wound dehiscence will be determined via ultrasound and clinical assessment of the surgical site. Wound dehiscence is defined as separation of the margins of the closed surgical incision made in the skin, with or without exposure/protrusion of underlying tissue. Wound dehiscence will be summarized as absolute counts and as descriptive proportions along with corresponding 95% confidence intervals. |
At time of procedure until 3 months after procedure (total estimated time: 3 months)
|
|
Rate of unplanned re-operation at the donor site
기간: At time of procedure until 3 months after procedure (total estimated time: 3 months)
|
Incidence of unplanned reoperation of the donor site from the initial surgical procedure will be assessed as they occur and reported as absolute counts and descriptive proportions along with corresponding 95% confidence intervals. |
At time of procedure until 3 months after procedure (total estimated time: 3 months)
|
|
Drain output in cc
기간: At time of drain removal (total estimated time: 1-4 weeks)
|
Total drain output in cc will be reported as means with standard deviation if data is normally distributed and as medians with interquartile and absolute ranges if skewed. |
At time of drain removal (total estimated time: 1-4 weeks)
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|
Time of transfer procedure to drain removal as assessed in days
기간: At time of procedure until time of drain removal (total estimated time 1-4 weeks)
|
Drains will be removed when output is less than 30 cc over 24 hours. Time of transfer procedure to drain removal in days will be reported as means with standard deviation if data is normally distributed and as medians with interquartile and absolute ranges if skewed. |
At time of procedure until time of drain removal (total estimated time 1-4 weeks)
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Justin Sacks, MD, MBA, FACS, Washington University School of Medicine
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
기타 연구 ID 번호
기타 연구 ID 번호
- 26-X358
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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