The prevention of hypertrophic scar formation by the application of platelet gel.

Conditions: excessive scarring
10041294
10014982
hypertrophic scarring

Registration Number: NL-OMON29794

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 35

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>At two days and six weeks the scars, lateral, medial, left and right, will be<br /><br>investigated for complications like hematoma, infection or dehiscence.<br /><br>At three months and a year clinically the height of the scars will be scored as<br /><br>normal, hypertrophic (raised above skin level, but within the confines of the<br /><br>original lesion) or keloid (raised above skin level, but beyond the confines of<br /><br>the orignal lesion). The width of the scar will be measured with a ruler and<br /><br>width and height will be studied intradermally with ultrasound (10 MHz).<br /><br>Standardized pictures will be made at 85 cm of the scar. The investigations<br /><br>will be done on a standard measuring point at three centimer of the outer<br /><br>border of every scar.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>At two days, three months and a year scar biopsies will be taken form the<br /><br>lateral scars. They will be snap frozen and stored in - 80C for further usage.<br /><br>The biopsies will be sectioned and stained with antibodies.<br /><br>Epidermis: MIB-1 against Ki-67 to score keratinocyte proliferation, Ks8.12<br /><br>against cytokeratin 16 to score keratinocyte differentiation and CD-1A against<br /><br>Langerhans cells.<br /><br>Epidermis and dermis: antilibodies against TGF-β1,2,3, PDGF, IL-1a, IL-4 en<br /><br>IGF-1,2. These growth factors are associated with excessive scar formation. If<br /><br>the clinical results are hopefull extra research will be done on messenger RNA<br /><br>expression from the different growth factors.</p><br>