- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07647562
Comparison of Outcomes of Plantar vs Groin Full-Thickness Skin Graft for Correction of Congenital Syndactyly of Hand
Congenital syndactyly is a condition present at birth in which two or more fingers are joined together. Surgical correction was performed to separate the fingers, improve hand appearance, and support better hand function. After separation of the fingers, a skin graft is often needed to cover the skin defect created during surgery. Full-thickness skin grafts may be taken from different donor sites. The groin has commonly been used as a donor site, but groin skin may differ from hand skin in color and texture. The plantar area of the foot has been considered as an alternative donor site because it may provide better color and texture matching and the donor scar is usually less visible.
This randomized controlled study compared the outcomes of plantar full-thickness skin grafts with groin full-thickness skin grafts in children who underwent surgical correction for congenital simple complete syndactyly of the hand. The study was conducted in the Department of Plastic Surgery, Sheikh Zayed Hospital, Rahim Yar Khan. Children aged 1 to 10 years with congenital simple complete syndactyly who required surgical correction with skin grafting were enrolled after written informed consent was obtained from their guardians. Children with complex syndactyly, associated congenital syndromes, infections, skin diseases, previous surgery on the affected hand, or missing postoperative photographs were not included.
The participants were assigned to one of two treatment groups by sealed opaque envelopes using a lottery method. One group received a plantar full-thickness skin graft, while the other group received a groin full-thickness skin graft. All operations were performed by a consultant plastic surgeon according to standard surgical practice. Postoperative follow-up was carried out at 2 weeks, 4 weeks, and 6 weeks after surgery.
The main purpose of the study was to compare postoperative complications between the two graft methods. These complications included scar contracture, web creep, donor-site hypertrophic scarring, and delayed healing. Scar contracture referred to tightening or shrinking of the graft or surrounding tissues that could limit finger movement or cause deformity. Web creep referred to distal migration of the reconstructed web space after surgery. Donor-site complications included raised or thickened scarring and delayed wound healing. These outcomes were assessed during follow-up visits by a consultant plastic surgeon who was blinded to the treatment group.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Punjab Province
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Rahim Yar Khan, Punjab Province, 파키스탄, 64200
- Sheikh Zayed Medical college/hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged 1 to 10 years of either gender with congenital simple complete syndactyly
- Cases requiring surgical correction with skin grafting.
- Patients with no prior surgical intervention on the affected hand.
Exclusion Criteria:
- Patients with complex syndactyly or other systemic conditions, including congenital syndromes, infections and skin diseases
- Patients with missing postoperative photographs.
공부 계획
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 |
|---|---|
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실험적: Group I - Plantar Full-Thickness Skin Graft
Participants assigned to this group received surgical correction of congenital simple complete syndactyly of the hand using a plantar full-thickness skin graft.
The graft was harvested from the plantar surface of the foot and used to cover the skin defect created after syndactyly release.
Participants were followed postoperatively at 2 weeks, 4 weeks, and 6 weeks for assessment of healing, scar contracture, web creep, donor-site complications, guardian satisfaction, and aesthetic outcome.
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Syndactyly release was performed under standard surgical protocol.
A full-thickness skin graft was harvested from the plantar surface of the foot and applied to the recipient defect after separation of the fused fingers.
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활성 비교기: Group II - Groin Full-Thickness Skin Graft
Participants assigned to this group received surgical correction of congenital simple complete syndactyly of the hand using a groin full-thickness skin graft.
The graft was harvested from the groin region and used to cover the skin defect created after syndactyly release.
Participants were followed postoperatively at 2 weeks, 4 weeks, and 6 weeks for assessment of healing, scar contracture, web creep, donor-site complications, guardian satisfaction, and aesthetic outcome.
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Syndactyly release was performed under standard surgical protocol.
A full-thickness skin graft was harvested from the groin region and applied to the recipient defect after separation of the fused fingers.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frequency of Scar Contracture
기간: 2 weeks, 4 weeks, and 6 weeks after surgery
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Scar contracture was assessed as abnormal tightening or shrinkage of the graft or surrounding tissue after syndactyly correction, resulting in visible tightness, deformity, or limitation of finger movement at the surgical site.
It was graded as none, mild, moderate, or severe according to clinical examination of range of motion and visible contracture.
Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
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2 weeks, 4 weeks, and 6 weeks after surgery
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Frequency of Web Creep
기간: 2 weeks, 4 weeks, and 6 weeks after surgery
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Web creep was assessed as distal migration of the reconstructed web space beyond the expected anatomical location after syndactyly correction.
It was evaluated by visual inspection and measurement from the metacarpophalangeal joint crease to the web apex.
Web creep was categorized as absent, less than 5 mm, 5 to 10 mm, or more than 10 mm.
Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
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2 weeks, 4 weeks, and 6 weeks after surgery
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Frequency of Donor-Site Hypertrophic Scarring
기간: 2 weeks, 4 weeks, and 6 weeks after surgery
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Donor-site hypertrophic scarring was assessed as a raised, thickened, erythematous, or pruritic scar confined within the boundaries of the original donor-site wound.
It was evaluated through visual and tactile examination of the donor site.
The outcome was recorded as present or absent.
Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
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2 weeks, 4 weeks, and 6 weeks after surgery
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Frequency of Delayed Healing
기간: 2 weeks, 4 weeks, and 6 weeks after surgery
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Delayed healing was assessed as failure of complete epithelialization of the graft or donor-site wound within more than 3 weeks after surgery, or the presence of wound dehiscence, infection, necrosis, or persistent exudate.
The outcome was recorded according to clinical wound examination.
Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
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2 weeks, 4 weeks, and 6 weeks after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Aesthetic Outcome Score
기간: 6 weeks after surgery
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The aesthetic outcome of the operated hand was assessed using a 1 to 10 score by a consultant plastic surgeon blinded to the treatment group.
The score was based on cosmetic appearance, including scar quality, web space appearance, symmetry, and overall visual restoration of the hand.
Lower scores indicated poor aesthetic outcome, while higher scores indicated excellent cosmetic outcome.
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6 weeks after surgery
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Healing Time
기간: Up to 6 weeks after surgery
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Healing time was recorded as the total number of days required for complete epithelialization of the graft and donor-site wounds after surgery.
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Up to 6 weeks after surgery
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Guardian Satisfaction Score
기간: 6 weeks after surgery
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Guardian satisfaction with the surgical outcome was recorded using a visual analogue scale ranging from 1 to 10. Lower scores indicated poor satisfaction, while higher scores indicated greater satisfaction with the overall surgical outcome, including appearance, function, and healing of the operated hand.
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6 weeks after surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Wardah Rehmat, Sheikh Zayed Medical college/Hospital, Rahimyar Khan
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- Sheikh ZMC/H6
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Congenital Syndactyly of Hand에 대한 임상 시험
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Catherine Vandepitte, M.D.Pacira Pharmaceuticals, Inc완전한