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Prospective Clinical Trials on Skin Wound Healing in Young and Aged Individuals (RESOLVE)

This study has been completed.
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
David Lumenta, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01040104
First received: December 28, 2009
Last updated: November 10, 2013
Last verified: November 2013

December 28, 2009
November 10, 2013
July 2009
July 2011   (final data collection date for primary outcome measure)
Time to wound healing / Scar maturation [ Time Frame: day14, day90, day180 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01040104 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prospective Clinical Trials on Skin Wound Healing in Young and Aged Individuals
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.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Skin biopsy Blood samples

Non-Probability Sample

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

  • Age
  • Cicatrix, Hypertrophic
  • Fibrosis
  • Diabetes Mellitus
  • Other: Skin sample
    Taken from regularly discarded tissue during routine operation
  • Other: Skin biopsy
    Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
  • Other: Skin biopsy
    Biopsy from skin graft harvest site during routine operation on day 0 and follow-up on day 90
  • Other: Blood taking
    Blood taking on day 0
  • Other: Blood taking
    Blood taking on day 90
  • Regular wound healing, young
    Regular skin repair, controlled wound healing conditions in young individuals
    Interventions:
    • Other: Skin sample
    • Other: Blood taking
  • Regular wound healing, aged
    Regular skin repair, controlled wound healing conditions in aged individuals
    Interventions:
    • Other: Skin sample
    • Other: Blood taking
  • Hypertrophic scarring, young
    Skin repair with and without hypertrophic scarring in young individuals
    Interventions:
    • Other: Skin biopsy
    • Other: Blood taking
    • Other: Blood taking
  • Hypertrophic scarring, aged
    Skin repair with and without hypertrophic scarring in aged individuals
    Interventions:
    • Other: Skin biopsy
    • Other: Blood taking
    • Other: Blood taking
  • Non-diabetic, young
    Skin repair in non-diabetic young individuals
    Interventions:
    • Other: Skin biopsy
    • Other: Blood taking
    • Other: Blood taking
  • Non-diabetic, aged
    Skin repair in non-diabetic aged individuals
    Interventions:
    • Other: Skin biopsy
    • Other: Blood taking
    • Other: Blood taking
  • Diabetic, young
    Skin repair in young diabetic individuals
    Interventions:
    • Other: Skin biopsy
    • Other: Blood taking
    • Other: Blood taking
  • Diabetic, aged
    Skin repair in aged diabetic individuals
    Interventions:
    • Other: Skin biopsy
    • Other: Blood taking
    • Other: Blood taking

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
Not Provided
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01040104
FP7-202047.WP.2.1-2.2-2.4, MUW-EK-Nr_015/2009
Yes
David Lumenta, MD, Medical University of Vienna
Medical University of Vienna
European Union
Principal Investigator: Lars P Kamolz, MD, MSc MUW
Medical University of Vienna
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP