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Active Not RecruitingNCT05316324

A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction

A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Acellular Dermal Matrix

Status
Active Not Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
353 (actual)
Sponsor
Memorial Sloan Kettering Cancer Center · Academic / Other
Sex
Female
Age
21 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when ADM is not used. These complications include infections, the need for Tissue Expander (TE) or implant removal, and other conditions that lead to additional surgery.

Conditions

Interventions

TypeNameDescription
PROCEDUREPrepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)Prepectoral Breast Reconstruction with (ADM)
PROCEDUREPrepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)Prepectoral Breast Reconstruction without ADM

Timeline

Start date
2022-03-23
Primary completion
2027-03-01
Completion
2027-03-01
First posted
2022-04-07
Last updated
2026-02-17

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT05316324. Inclusion in this directory is not an endorsement.

A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction (NCT05316324) · Clinical Trials Directory