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

November 10, 2013 updated by: David Lumenta, MD, Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Blood taking
Blood taking on day 90
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
Other: Blood taking
Blood taking on day 90
Hypertrophic scarring, young
Skin repair with and without hypertrophic scarring in young individuals
Other: Blood taking
Blood taking on day 0
Other: Blood taking
Blood taking on day 90
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
Hypertrophic scarring, aged
Skin repair with and without hypertrophic scarring in aged individuals
Other: Blood taking
Blood taking on day 0
Other: Blood taking
Blood taking on day 90
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
Non-diabetic, young
Skin repair in non-diabetic young individuals
Other: Blood taking
Blood taking on day 0
Other: Blood taking
Blood taking on day 90
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
Non-diabetic, aged
Skin repair in non-diabetic aged individuals
Other: Blood taking
Blood taking on day 0
Other: Blood taking
Blood taking on day 90
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
Diabetic, young
Skin repair in young diabetic individuals
Other: Blood taking
Blood taking on day 0
Other: Blood taking
Blood taking on day 90
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
Diabetic, aged
Skin repair in aged diabetic individuals
Other: Blood taking
Blood taking on day 0
Other: Blood taking
Blood taking on day 90
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to wound healing / Scar maturation
Time Frame: day14, day90, day180
day14, day90, day180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

European Union

Investigators

  • Principal Investigator: Lars P Kamolz, MD, MSc, MUW

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

December 28, 2009

First Submitted That Met QC Criteria

December 28, 2009

First Posted (Estimate)

December 29, 2009

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 10, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FP7-202047.WP.2.1-2.2-2.4
  • MUW-EK-Nr_015/2009 (Other Identifier: MUVienna)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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