Tissue Response to Implanted Collagen Matrix in Implant Based Breast Reconstruction * A Histological Study

Completed

• Conditions: Breast cancer & Breast reconstruction; 10006295

• Registration Number: NL-OMON40350
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Eligible for the study are women aged 18 and over, with breast cup size C or above, who are intended to undergo skin sparing mastectomy with two stage breast reconstruction (with a tissue expander and an implant).

Exclusion Criteria

Smokers

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main endpoints are the histological parameters:<br /><br>- Revascularisation of the Strattice* sheet.<br /><br>- Immune cell response<br /><br>- Granulation tissue (fibroblast infiltration)<br /><br>- Collagen remodelling (fibrosis)<br /><br>Another main endpoint is:<br /><br>- Bacterial colonization</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>