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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05316324
• Other study ID #: 22-071
• Status: Recruiting
• Phase: Phase 3
• Start date: March 23, 2022
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Evan Matros, MD
• Phone: 646-608-8044
• Email: matrose[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 352
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Females aged 21-60 years

• Planning to undergo unilateral or bilateral mastectomy, prophylactically or to treat breast cancer

• Planning to undergo immediate two-stage prosthetic breast reconstruction with TE placement as the first stage

• Planning to undergo nipple-sparing or skin-sparing mastectomy

• Adequate mastectomy skin perfusion or adequate perfusion but nonviable mastectomy skin that can be excised (=4 cm) at the defect margins with otherwise adequate perfusion

• Intraoperative confirmation of prepectoral plane viability by operating physician

Exclusion Criteria:

• History of radiotherapy to the operative breast

• Current smoker

• Non-English speaking patients

• Planning to undergo direct-to-implant reconstruction

• Prior sternotomy

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)
Prepectoral Breast Reconstruction with (ADM)
• Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)
Prepectoral Breast Reconstruction without ADM

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Rockville Centre	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	The Plastic Surgery Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who experience major complications	Listed below are definitions for 90-day major complications for TEs (i.e., infection, explantation, and reoperation for any cause, including mastectomy flap necrosis): Infection defined as: Any event requiring the restart of antibiotics (oral or intravenous) after completion of initial perioperative antibiotics; Admission to the hospital for signs and symptoms of cellulitis (redness on breast mound) requiring antibiotics; Purulent drainage from the surgical site or incision; Explantation defined as the need for removal of a TE for any cause; Reoperation defined as skin excision performed in either the clinic or the operating room for mastectomy skin flap necrosis, surgical incision dehiscence, pending skin breakdown or another surgical complication	90 days
Secondary	Estimate rates of minor complications (specifically seroma)	Minor complication for (Tissue Expanders) TEs are defined as: o Seroma: Clinically significant noninfected fluid collection requiring either needle aspiration or drain replacement	90 days

External Links

•   Memorial Sloan Kettering Cancer Center