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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Vienna, Austria, 1090
- Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Regular wound healing, young
Regular skin repair, controlled wound healing conditions in young individuals
|
Taken from regularly discarded tissue during routine operation
Blood taking on day 0
Blood taking on day 90
|
|
Regular wound healing, aged
Regular skin repair, controlled wound healing conditions in aged individuals
|
Taken from regularly discarded tissue during routine operation
Blood taking on day 0
Blood taking on day 90
|
|
Hypertrophic scarring, young
Skin repair with and without hypertrophic scarring in young individuals
|
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
|
|
Hypertrophic scarring, aged
Skin repair with and without hypertrophic scarring in aged individuals
|
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
|
|
Non-diabetic, young
Skin repair in non-diabetic young individuals
|
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
|
|
Non-diabetic, aged
Skin repair in non-diabetic aged individuals
|
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
|
|
Diabetic, young
Skin repair in young diabetic individuals
|
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
|
|
Diabetic, aged
Skin repair in aged diabetic individuals
|
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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Time to wound healing / Scar maturation
Lasso di tempo: day14, day90, day180
|
day14, day90, day180
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Lars P Kamolz, MD, MSc, MUW
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- FP7-202047.WP.2.1-2.2-2.4
- MUW-EK-Nr_015/2009 (Altro identificatore: MUVienna)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Skin sample
-
Hillel Yaffe Medical CenterSconosciuto
-
Hallym University Kangnam Sacred Heart HospitalCompletatoFerite e lesioni | LacerazioniCorea, Repubblica di
-
Nielsen BioSciences, Inc.U.S. Army Medical Research and Development CommandCompletatoLeishmaniosi cutaneaStati Uniti
-
Syneron MedicalCompletatoDermatologia EsteticaStati Uniti
-
Mayo ClinicIscrizione su invitoFerita drenante | Fistola-in-anoStati Uniti
-
Roxall Medicina España S.ACompletato
-
AllerdermCompletatoDermatite da contattoDanimarca, Stati Uniti
-
Syneron MedicalSconosciuto
-
Pusan National University Yangsan HospitalCompletatoGrasso corporeoCorea, Repubblica di
-
Ege UniversityNon ancora reclutamentoDolore | PauraTurchia (Türkiye)