Nanofat Injection and Fractional CO2 Laser for Post-Traumatic Atrophic Scars (NANOCO2-PTS)
Safety and Efficacy of Nanofat Injection and Fractional CO2 Laser: Monotherapy Versus Combined Therapy in Post-Traumatic Atrophic Scars
연구 개요
상태
상세 설명
Post-traumatic atrophic scars are characterized by dermal collagen loss, epidermal thinning, and alterations in skin texture and pigmentation. These scars may result in significant cosmetic disfigurement and negatively affect patients' quality of life. Despite the availability of multiple treatment modalities, no single intervention has consistently demonstrated optimal efficacy.
Fractional carbon dioxide (CO2) laser induces controlled microthermal injury that stimulates collagen remodeling and skin regeneration. Autologous nanofat grafting, which is rich in adipose-derived regenerative cells and growth factors, has emerged as a promising regenerative treatment for improving skin quality and scar remodeling. Combining these two modalities may provide synergistic effects by enhancing tissue regeneration and improving both structural and aesthetic outcomes.
This prospective comparative study was conducted to evaluate and compare the safety and efficacy of fractional CO2 laser monotherapy, autologous nanofat injection monotherapy, and combination therapy in the treatment of post-traumatic atrophic scars. Clinical efficacy was assessed using physician evaluation, Vancouver Scar Scale scores, and patient satisfaction, while dermoscopic and histopathological examinations were performed to investigate treatment-induced structural changes and the mechanisms underlying scar improvement.
The study aimed to determine whether combined therapy offers superior clinical and regenerative outcomes compared with either treatment alone while maintaining an acceptable safety profile.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Gharbia Governorate
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Tanta, Gharbia Governorate, 이집트, 31527
- Tanta University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Male or female participants aged 12 years or older.
- Presence of post-traumatic atrophic scar(s) of at least 6 months' duration.
- No scar treatment received during the previous 6 months.
- Willingness and ability to provide written informed consent (or assent with -parental/guardian consent for minors, according to local regulations).
- Willingness to comply with study procedures and follow-up assessments.
Exclusion Criteria:
- Hemoglobin <10 g/dL.
- Active infection or viral skin disease.
- Coagulopathy or hemophilia.
- Current anticoagulant therapy.
- Diabetes mellitus.
- History of keloid formation.
- History of malignancy or prior radiation therapy.
- Immunosuppression.
- Long-term systemic corticosteroid therapy.
- Photosensitivity disorders.
- Pregnancy or breastfeeding.
- Renal or hepatic disease.
- Systemic diseases affecting wound healing.
- Thin patients with insufficient adipose tissue for adipose tissue harvesting.
- Previous scar treatment within the preceding 6 months.
- Use of systemic retinoids within the preceding 6 months. -Use of topical retinoids within the preceding 2 weeks.-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Fractional CO2 Laser
Participants will receive three sessions of fractional carbon dioxide laser treatment at one-month intervals.
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Fractional ablative carbon dioxide laser (10,600 nm) administered in three sessions at one-month intervals for treatment of post-traumatic atrophic scars.
다른 이름들:
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활성 비교기: Autologous Nanofat Injection
Participants will receive one session of autologous nanofat injection for treatment of post-traumatic atrophic scars.
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A single session of intradermal injection of autologous nanofat prepared from centrifuged and mechanically emulsified adipose tissue for treatment of post-traumatic atrophic scars.
다른 이름들:
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활성 비교기: Fractional CO2 Laser + Autologous Nanofat Injection
Participants will receive three sessions of fractional carbon dioxide laser at one-month intervals followed by one session of autologous nanofat injection.
|
Fractional ablative carbon dioxide laser (10,600 nm) administered in three sessions at one-month intervals for treatment of post-traumatic atrophic scars.
다른 이름들:
A single session of intradermal injection of autologous nanofat prepared from centrifuged and mechanically emulsified adipose tissue for treatment of post-traumatic atrophic scars.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Vancouver Scar Scale Score
기간: Baseline and 3 months after completion of treatment
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The change in scar severity assessed using the Vancouver Scar Scale (VSS), including vascularity, pigmentation, and pliability, from baseline to the post-treatment assessment.
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Baseline and 3 months after completion of treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physician Global Assessment of Clinical Improvement
기간: 3 months after completion of treatment
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Clinical improvement evaluated by three blinded dermatologists using a quartile grading scale (poor: 0-25%, fair: 25-50%, good: 50-75%, excellent: 75-100% improvement).
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3 months after completion of treatment
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- TANTA-33465-11-19
- TU-DERM-PTAS-2020-01 (레지스트리 식별자: Internal Protocol Number)
- 33465/11/19 (기타 식별자: Ethics Approval Number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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