The objective of our observational clinical trial is to quantify the apoptosisrates of fibroblasts and growth-factorchanges in hypertrophic (burn) scars treated with pressure and/or silicone therapy.
ID
Source
Brief title
Condition
- Injuries by physical agents
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Apoptosisrate of fibroblasts
Secondary outcome
Concentrations of TGFbeta 1, 2 and 3 and MMP 9
The histological findings will also be correlated to the clinical differences
in erythema and thickness.
Background summary
Hypertrophic scarring is a tremendous problem in (reconstructive) surgery and
in particular in burncare. The excess scar formation leads to functional
problems due to contractures, continuous pain and itching sensations and often
to psychosocial problems.
Two of the most widely used treatments in hypertrohic scarring are pressure
therapy and the newer silicone-therapy. Both treatmentmodalities work through
applying continued pressure or occlusion, delivered by garnments or sheets
which must be worn up to one year.
Although pressure and silicone therapy become more widely used, little is known
about the histological workingmechanism of both.
Study objective
The objective of our observational clinical trial is to quantify the
apoptosisrates of fibroblasts and growth-factorchanges in hypertrophic (burn)
scars treated with pressure and/or silicone therapy.
Study design
In our study we will follow 120 patients with hypertrophic scarring. The
studypopulation will consist of four patientgroups: one group with both
pressure and silicones, one group with only pressure, one group with only
silicones and one control group. At start, 1, 2, 3, 6, 12 and 18 months they
will be evaluated by Colorimetry and Dermascan Ultrasound. Along with this
clinical evaluation a 4 mm punch-biopsy will be taken.
In those scar samples apoptosis, necrosis and proliferation of fibroblasts and
the concentrations of the most important growth-factors in wound maturation,
TGF beta 1, 2 and 3 will be determined with immunoassay techniques, as also the
concentration of the main remodeling proteinase, matrix metallo proteinase MMP9.
Intervention
The intervention consist of the application of pressure with or without
silicone inlays on the hypertrophic scars.
Study burden and risks
Because of the non-invasive character of both pressure and siliconetherapy, no
risk are forseen for patients participating in this study.
P. Debyelaan 25
6202 AZ Maastricht
Nederland
P. Debyelaan 25
6202 AZ Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
- Only patients with an objectified developing hypertrophy as measured by colorimetry will be included. An erythema value of 140% of normal healthy skin is required.
- All scars younger than 6 months post-woundclosure can be included
Exclusion criteria
- Age <18yrs, > 65yrs
- Preëxistent skin disease
-Degenerative or metabolic disorders (use of immunosupressives, immuno
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14068.068.06 |