In previous studies is found that the sequence of processes leading to excessive scar formation starts during the operation. Abnormal epidermal-dermal interactions and excessive immune reactions seem to play an important role.On theoretical base an…
ID
Source
Brief title
Condition
- Soft tissue neoplasms benign
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
At two days and six weeks the scars, lateral, medial, left and right, will be
investigated for complications like hematoma, infection or dehiscence.
At three months and a year clinically the height of the scars will be scored as
normal, hypertrophic (raised above skin level, but within the confines of the
original lesion) or keloid (raised above skin level, but beyond the confines of
the orignal lesion). The width of the scar will be measured with a ruler and
width and height will be studied intradermally with ultrasound (10 MHz).
Standardized pictures will be made at 85 cm of the scar. The investigations
will be done on a standard measuring point at three centimer of the outer
border of every scar.
Secondary outcome
At two days, three months and a year scar biopsies will be taken form the
lateral scars. They will be snap frozen and stored in - 80C for further usage.
The biopsies will be sectioned and stained with antibodies.
Epidermis: MIB-1 against Ki-67 to score keratinocyte proliferation, Ks8.12
against cytokeratin 16 to score keratinocyte differentiation and CD-1A against
Langerhans cells.
Epidermis and dermis: antilibodies against TGF-β1,2,3, PDGF, IL-1α, IL-4 en
IGF-1,2. These growth factors are associated with excessive scar formation. If
the clinical results are hopefull extra research will be done on messenger RNA
expression from the different growth factors.
Background summary
Excessive scar formation following burns, trauma or surgery, can be a big
functional, cosmetic and psychologhical problem for patients, especially for
children and young adults.
To prevent this scar formation in the skin (hypertrophic scars and/or keloids),
but also in tendons, nerves or bowels, is an important scientific challenge.
Study objective
In previous studies is found that the sequence of processes leading to
excessive scar formation starts during the operation. Abnormal epidermal-dermal
interactions and excessive immune reactions seem to play an important role.
On theoretical base an acceleration of the healing processes could give a
better scar. In this project it will be investigated if the application of an
autologous platelet gel in the wound during the operation can prevent the
formation of scar hypertrophy.
Study design
The clinical part of the study will be at the department of Plastic Surgery in
the University Medical Center Groningen. The breast-reduction scar model will
be used. 35 patients will be included.
Half of the caudal infra-mammary wound (rigth medial and left lateral or vice
versa) of every breast will be treated with the gel. The study is prospective,
randomised and blinded. Patients will be controlled at two days, six weeks,
three months and a year.
Study burden and risks
The breast-reduction operation and post-operative controls are conform normal
protocol. The control sessions will take more time and at two days, three
months and a year biopsies will be taken.
From autologous platelet gel, no adverse effects were reported in literature.
Off course to predict the exact effect in normal wound healing is not possible.
Postbus 30.001
9700 RB Groningen
Nederland
Postbus 30.001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
In this study 35 healthy women will be included who will be operated for breast-reduction surgery. The technique used must result in an infra-mammary scar. The patients will be older than 18 years of age.
Exclusion criteria
Not healthy enough to undergo the operation. Pregnant women.
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 | NL12635.042.06 |