Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON29794
Enrollment
35
Registered
2007-08-10
Start date
2006-09-01
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

excessive scarring hypertrophic scarring

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Not healthy enough to undergo the operation. Pregnant women.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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-1a, 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)