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
  Purpose

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.


Condition Intervention
Age
Cicatrix, Hypertrophic
Fibrosis
Diabetes Mellitus
Other: Skin sample
Other: Skin biopsy
Other: Blood taking

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pilot Study of Prospective Clinical Trials on Skin Wound Healing in Young and Aged Individuals

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Time to wound healing / Scar maturation [ Time Frame: day14, day90, day180 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Skin biopsy Blood samples


Enrollment: 51
Study Start Date: July 2009
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Regular wound healing, young
Regular skin repair, controlled wound healing conditions in young individuals
Other: Skin sample
Taken from regularly discarded tissue during routine operation
Other: Blood taking
Blood taking on day 0
Regular wound healing, aged
Regular skin repair, controlled wound healing conditions in aged individuals
Other: Skin sample
Taken from regularly discarded tissue during routine operation
Other: Blood taking
Blood taking on day 0
Hypertrophic scarring, young
Skin repair with and without hypertrophic scarring in young individuals
Other: Skin biopsy
Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
Other: Blood taking
Blood taking on day 0
Other: Blood taking
Blood taking on day 90
Hypertrophic scarring, aged
Skin repair with and without hypertrophic scarring in aged individuals
Other: Skin biopsy
Skin biopsy from regions exhibiting normal and/or hypertrophic scarring at day 0 and day 90
Other: Blood taking
Blood taking on day 0
Other: Blood taking
Blood taking on day 90
Non-diabetic, young
Skin repair in non-diabetic young individuals
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
Non-diabetic, aged
Skin repair in non-diabetic aged individuals
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
Diabetic, young
Skin repair in young diabetic individuals
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
Diabetic, aged
Skin repair in aged diabetic individuals
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040104

Locations
Austria
Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
European Union
Investigators
Principal Investigator: Lars P Kamolz, MD, MSc MUW
  More Information

Additional Information:
Publications:

Responsible Party: David Lumenta, MD, Dr, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01040104     History of Changes
Other Study ID Numbers: FP7-202047.WP.2.1-2.2-2.4, MUW-EK-Nr_015/2009
Study First Received: December 28, 2009
Last Updated: November 10, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
wound healing
hypertrophic scar
skin transplantation
diabetes mellitus

Additional relevant MeSH terms:
Cicatrix, Hypertrophic
Diabetes Mellitus
Hypertrophy
Cicatrix
Endocrine System Diseases
Fibrosis
Glucose Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 22, 2014