Prospective Clinical Trials on Skin Wound Healing in Young and Aged Individuals (RESOLVE)
Pilot Study of Prospective Clinical Trials on Skin Wound Healing in Young and Aged Individuals
Regular wound healing follows a well-ordered sequence of overlapping phases: inflammation, proliferation, maturation and remodelling.
In the young, damage to an organ mostly triggers fully regenerative mechanisms called "primary" wound healing. Repeated damage in young individuals may cause "secondary" wound healing eg. scar formation reflecting a rescue program, in which reorganisation has failed.
Organ failure in the ageing organism is characterized by a progressive loss of its capability to achieve an orderly reactivation of organ repair, and results in a combination of chronic inflammation and fibroproliferative, non-regenerative repair affecting several organs, including lung, liver and skin.
RESOLVE's objective is to identify, characterize, and validate molecular targets responsible for shifting primary organ repair towards fibroproliferative wound healing as a result of an age-dependent loss of regulatory control.
The structured approach is based on
- different forms of wound healing,
- different human diseases and
- different genetic backgrounds,
aiming to provide future diagnostic tools in various organs, to create transgenic animal test systems, and to identify molecular targets involved in fibroproliferative wound healing.
연구 개요
상태
상세 설명
Cutaneous scars are frequently encountered conditions. The process of wound repair, however, is complicated, and various factors contribute to different types of scarring (eg. hypertrophic, atrophic).
WP 2.1: Regular skin repair
In elective plastic surgery most excised operative skin specimens are usually discarded, and represent an excellent opportunity of harvesting skin biopsies without additional invasive measures. This work package analyzes skin samples of individuals after elective plastic surgery with normal wound healing serving as control group.
WP 2.2: Skin repair with and without hypertrophic scar formation
A classic example of fibroproliferative repair in the skin is hypertrophic scarring classified as a dermal skin lesion, which is raised above skin level, stays within the confines of the initial wound and increases in size by pushing out the margins of the scar without invading the surrounding normal tissue.
Hypertrophic scarring is a condition commonly observed after burns and in regions of prolonged wound healing (>21 days). The underlying pathology of hypertrophic scarring, however, is poorly understood. Hypertrophic scars can be managed conservatively, and only require surgical intervention under special circumstances.
This work package analyzes the clinical and molecular response to a standard treatment regimen in skin regions with and without hypertrophic scars after skin injuries.
WP 2.4: Wound healing in normal and diabetic individuals
Diabetes mellitus is a known factor to cause impaired wound healing. Due to microangiopathic, macroangiopathic and other conditions resulting from atherosclerosis and peripheral neuropathy wound healing in diabetic individuals is usually delayed (hypotrophic, atrophic) and often complicated by immunosuppression and superinfections. The rising prevalence of diabetes mellitus in the elderly population makes it necessary to understand its related processes in relevant clinical wound models.
Split-thickness skin-grafting is a commonly applied technique in plastic surgery, and donor sites of previously uninjured skin regions spontaneously heal within two weeks, representing an ideal condition to monitor clinical and molecular changes in diseased vs. non-diseased states.
This work package analyzes skin repair in donor sites of split-thickness skin grafts in non-diabetic and diabetic individuals.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Vienna, 오스트리아, 1090
- Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
WP 2.1 Individuals due for planned elective plastic surgery with regular wound healing
WP 2.2 Individuals, who suffered from burns, trauma or having undergone any type of previous surgery with and without hypertrophic scar formation
WP 2.4 Individuals, who require split-thickness skin grafting for skin defects with or without diabetes mellitus
설명
WP2.1
Inclusion Criteria:
- age 18-45 and 55-85 years, respectively
Exclusion Criteria:
- past medical history of hypertrophic scarring or keloid disease
- cardiac disease adversely affecting peripheral blood flow
- active neoplastic disease
- immunosuppressive condition, congenital or acquired
- anemia
- autoimmune disorder
- acute or chronic renal failure
- liver cirrhosis or active hepatitis
- active substance-abuse disorder
- severe underweight (body mass index <16)
- endocrinological disorder
- pregnancy or lactation for women of child-bearing age
WP2.2
Inclusion Criteria:
- age 18-45 and 55-85 years, respectively
- normal and/or hypertrophic scars
- Baux score <100
Exclusion Criteria:
- sepsis
- electrical and/or chemical burn
- clinically significant wound infection in areas of planned biopsies
- cardiac disease adversely affecting peripheral blood flow
- active neoplastic disease
- immunosuppressive condition, congenital or acquired
- autoimmune disorder
- acute or chronic renal failure
- liver cirrhosis or active hepatitis
- active substance-abuse disorder
- severe underweight (body mass index <16)
- endocrinological disorder
- pregnancy or lactation for women of child-bearing age
WP 2.4
Inclusion Criteria:
- age 18-45 and 55-85 years, respectively
Exclusion Criteria:
- cardiac disease adversely affecting peripheral blood flow
- active neoplastic disease
- immunosuppressive condition, congenital or acquired
- anemia
- autoimmune disorder
- acute or chronic renal failure
- liver cirrhosis or active hepatitis
- substance-abuse disorder
- severe underweight (body mass index <16)
- thyroid function disorder
- pregnancy or lactation for women of child-bearing age
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Regular wound healing, young
Regular skin repair, controlled wound healing conditions in young individuals
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Taken from regularly discarded tissue during routine operation
Blood taking on day 0
Blood taking on day 90
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Regular wound healing, aged
Regular skin repair, controlled wound healing conditions in aged individuals
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Taken from regularly discarded tissue during routine operation
Blood taking on day 0
Blood taking on day 90
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Hypertrophic scarring, young
Skin repair with and without hypertrophic scarring in young individuals
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Blood taking on day 0
Blood taking on day 90
Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
Biopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90
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Hypertrophic scarring, aged
Skin repair with and without hypertrophic scarring in aged individuals
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Blood taking on day 0
Blood taking on day 90
Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
Biopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90
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Non-diabetic, young
Skin repair in non-diabetic young individuals
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Blood taking on day 0
Blood taking on day 90
Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
Biopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90
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Non-diabetic, aged
Skin repair in non-diabetic aged individuals
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Blood taking on day 0
Blood taking on day 90
Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
Biopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90
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Diabetic, young
Skin repair in young diabetic individuals
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Blood taking on day 0
Blood taking on day 90
Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
Biopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90
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Diabetic, aged
Skin repair in aged diabetic individuals
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Blood taking on day 0
Blood taking on day 90
Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
Biopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Time to wound healing / Scar maturation
기간: day14, day90, day180
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day14, day90, day180
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Gangemi EN, Gregori D, Berchialla P, Zingarelli E, Cairo M, Bollero D, Ganem J, Capocelli R, Cuccuru F, Cassano P, Risso D, Stella M. Epidemiology and risk factors for pathologic scarring after burn wounds. Arch Facial Plast Surg. 2008 Mar-Apr;10(2):93-102. doi: 10.1001/archfaci.10.2.93.
- Izadi K, Ganchi P. Chronic wounds. Clin Plast Surg. 2005 Apr;32(2):209-22. doi: 10.1016/j.cps.2004.11.011.
- Blakytny R, Jude E. The molecular biology of chronic wounds and delayed healing in diabetes. Diabet Med. 2006 Jun;23(6):594-608. doi: 10.1111/j.1464-5491.2006.01773.x.
- Komesu MC, Tanga MB, Buttros KR, Nakao C. Effects of acute diabetes on rat cutaneous wound healing. Pathophysiology. 2004 Oct;11(2):63-67. doi: 10.1016/j.pathophys.2004.02.002.
- Niessen FB, Spauwen PH, Schalkwijk J, Kon M. On the nature of hypertrophic scars and keloids: a review. Plast Reconstr Surg. 1999 Oct;104(5):1435-58. doi: 10.1097/00006534-199910000-00031. No abstract available.
- Rockwell WB, Cohen IK, Ehrlich HP. Keloids and hypertrophic scars: a comprehensive review. Plast Reconstr Surg. 1989 Nov;84(5):827-37. doi: 10.1097/00006534-198911000-00021. No abstract available.
- Gottrup F, Agren MS, Karlsmark T. Models for use in wound healing research: a survey focusing on in vitro and in vivo adult soft tissue. Wound Repair Regen. 2000 Mar-Apr;8(2):83-96. doi: 10.1046/j.1524-475x.2000.00083.x.
- Ashcroft GS, Mills SJ, Ashworth JJ. Ageing and wound healing. Biogerontology. 2002;3(6):337-45. doi: 10.1023/a:1021399228395.
- Gosain A, DiPietro LA. Aging and wound healing. World J Surg. 2004 Mar;28(3):321-6. doi: 10.1007/s00268-003-7397-6. Epub 2004 Feb 17.
- Crooks A. How does ageing affect the wound healing process? J Wound Care. 2005 May;14(5):222-3. doi: 10.12968/jowc.2005.14.5.26777.
- Deitch EA, Wheelahan TM, Rose MP, Clothier J, Cotter J. Hypertrophic burn scars: analysis of variables. J Trauma. 1983 Oct;23(10):895-8.
- Bombaro KM, Engrav LH, Carrougher GJ, Wiechman SA, Faucher L, Costa BA, Heimbach DM, Rivara FP, Honari S. What is the prevalence of hypertrophic scarring following burns? Burns. 2003 Jun;29(4):299-302. doi: 10.1016/s0305-4179(03)00067-6.
- Oliveira GV, Chinkes D, Mitchell C, Oliveras G, Hawkins HK, Herndon DN. Objective assessment of burn scar vascularity, erythema, pliability, thickness, and planimetry. Dermatol Surg. 2005 Jan;31(1):48-58. doi: 10.1111/j.1524-4725.2005.31004.
- Mustoe TA, Cooter RD, Gold MH, Hobbs FD, Ramelet AA, Shakespeare PG, Stella M, Teot L, Wood FM, Ziegler UE; International Advisory Panel on Scar Management. International clinical recommendations on scar management. Plast Reconstr Surg. 2002 Aug;110(2):560-71. doi: 10.1097/00006534-200208000-00031.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
Skin sample에 대한 임상 시험
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Seoul National University Hospital알려지지 않은
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ArjohuntleighMagellan Medical Technology Consultants, Inc.알려지지 않은
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University of BirminghamUniversity College, London; National Institute for Health Research, United Kingdom모병