Primary objective: to prove or exclude an association between the amount of TFG-*3 in the blood and the development of HTS and keloid.Secundary objectives:- to research the association between collagen composition of the skin and the POSAS score;-…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Amount of TGF*-3 in the blood;
- Patient and Observer Scar Assessment Scale scores;
- Judgment of quality of wound healing by physician through photographs of the
scar.
Secondary outcome
- Amount of TGF*-1 in tissue specimens, blood and drainfluids;
- Amount of TGF*-2 in tissue specimens, blood and drainfluids;
- Amount of TGF*-3 in tissue specimens, blood and drainfluids;
- Amount of PDGF in tissue specimens, blood and drainfluids;
- Amount of chemokines in tissue specimens, blood and drainfluids;
- Amount of hydrocylysines (from which collagen I/III ratio is calculated) in
tissue specimens;
- Amount of pyridinoline cross-links per collagen molecule in tissue specimens;
- Ratio collagenous-/non-collagenous proteins in tissue specimens;
- Percentage of patients with HTS;
- Percentage of patients with keloid;
- Sociodemographic information;
- Treatment related data;
- Co-morbidity.
Background summary
Hypertrophic scars (HTS) and keloid are thickened scars, often with
considerable cosmetic and functional morbidity. Individuals who suffer from
these types of scarring have a higher POSAS score (score indicating the level
of abnormality of a scar) than individuals with normal scars. The process of
this type of scarring is unknown. We do know, however, that HTS and keloid
contain a higher amount of collagen than normal scars. Collagensyntheses in
scars is stimulated by profibrotic cytokines and inhibited by antifibrotic
cytokines like TGF-*3. Theoretically, HTS- or keloid-forming skin produces less
TGF-*3 than skin that scars normally. Assuming that this difference is visible
in the blood as well, the hypothesis of this research is that blood of persons
with a high POSAS score (abnormal scars) contains less TGF-*3 than blood of
persons with a lower POSAS score (normal scars).
Study objective
Primary objective: to prove or exclude an association between the amount of
TFG-*3 in the blood and the development of HTS and keloid.
Secundary objectives:
- to research the association between collagen composition of the skin and the
POSAS score;
- to research risk factors for a high POSAS score;
- to give an indication of the incidences of HTS and keloid in the Dutch
population.
Study design
Observational study.
Study burden and risks
INTERVENTION
Blood is taken before the operation. During the operation (median sternotomy)
tissue specimens of 1x0,5 cm are taken from the rim of the incision. In
CABG-procedures a specimen of the venous or, when possible, the arterial graft
is taken as well.
NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT
No serious are associated with participation.
- Blood will be drawn from the iv-line of the patient just before surgery.
- Biopsies are taken during the procedure and will not cause additional
complaints or disturb woundhealing.
- In addition to the regular hospital visits, subjects will visit the St.
Antonius Hospital 3 times extra for the purpose of this research.
Koekoekslaan 1
3435 CM NIEUWEGEIN
Nederland
Koekoekslaan 1
3435 CM NIEUWEGEIN
Nederland
Listed location countries
Age
Inclusion criteria
- Patient will undergo elective surgery by median sternotomy in the St. Antonius Hospital Nieuwegein
- Patient is older than 18 years
Exclusion criteria
- Incompetent
- Connective tissue disease
- Scarring of surgical site
- Use of steroids
- Participation in other trials
Design
Recruitment
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 | NL19953.100.07 |