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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40350

Enrollment

Registered

2014-02-26

Start date

2015-06-09

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Breast cancer & Breast reconstruction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Smokers

Design outcomes

Primary

Measure	Time frame
Main endpoints are the histological parameters: - Revascularisation of the Strattice* sheet. - Immune cell response - Granulation tissue (fibroblast infiltration) - Collagen remodelling (fibrosis) Another main endpoint is: - Bacterial colonization	—

Countries

Netherlands

Outcome results