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

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05316324
• Collaborator: The Plastic Surgery Foundation (Other)
• Enrollment: 352
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.3
• Patients Per Site Per Month: 15.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Procedure: Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM); Procedure: Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 352 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Acellular Dermal Matrix
• Actual Study Start Date: Mar 23, 2022
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prepectoral Breast Reconstruction with ADM	Procedure: Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM); Prepectoral Breast Reconstruction with (ADM)
Experimental: Prepectoral Breast Reconstruction without ADM	Procedure: Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM); Prepectoral Breast Reconstruction without ADM

Outcome Measures

Primary Outcome Measures

1. Percentage of patients who experience major complications [90 days]

   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

Secondary Outcome Measures

1. Estimate rates of minor complications (specifically seroma) [90 days]

   Minor complication for (Tissue Expanders) TEs are defined as: o Seroma: Clinically significant noninfected fluid collection requiring either needle aspiration or drain replacement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

• Current smoker

• Non-English speaking patients

• Planning to undergo direct-to-implant reconstruction

• BMI >35

• Prior sternotomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center
• The Plastic Surgery Foundation

Investigators

• Principal Investigator: Evan Matros, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT05316324
• Other Study ID Numbers: 22-071
• First Posted: Apr 7, 2022
• Last Update Posted: Jul 8, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Memorial Sloan Kettering Cancer Center: Acellular Dermal Matrix; Breast Reconstruction; Mastectomy; 22-071

Study Results

No Results Posted as of Jul 8, 2022