Comparing AlloDerm and DermACELL in Breast Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-21

Study Completion Date

2022-07-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will compare 90-day complication rates between breasts reconstructed with tissue expanders and AlloDerm vs. DermACELL, with each patient serving as her own comparator.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Retrospective Breast Reconstruction Study

NCT04060134

Breast Cancer

COMPLETED

A Comparison of Dermal Autograft to AlloDerm in Breast Reconstruction

NCT01561287

COMPLETED PHASE4

Pre-pectoral AlloDerm® to Reinforce Tissues in Tissue Expander Breast Reconstruction

NCT03195322

Postoperative Pain Postoperative Nausea and Vomiting Quality of Life +2 more

COMPLETED NA

Reconstruction Outcomes in Immediate Post-mastectomy Breast Reconstruction With ADM

NCT03145337

Breast Reconstruction

UNKNOWN NA

BREAST ADM Trial for Alloplastic Breast Reconstruction

NCT04661501

Breast Reconstruction

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators' study aims to determine if there is a significant difference in postoperative outcomes when using DermACELL or AlloDerm, two acellular dermal matrix products, in breast reconstruction. Patients who are undergoing bilateral mastectomies with tissue expanders and acellular dermal matrix (ADM) with one of the investigators' two surgeons, Dr. Steven Davison or Dr. Ximena Pinell, are eligible to be enrolled. Patients' breasts will be randomized to receive either AlloDerm or DermACELL so that each patient had AlloDerm placed in one breast and DermACELL placed in the other on the day of surgery. Then, the following data for each breast will be recorded: time until drain removal, total drain output, time until first expander fill, and occurrences of infection and seroma.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acellular Dermal Matrix in Breast Reconstruction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

At the time of surgery, the assignment of AlloDerm vs. DermACELL to the patient's left and right breasts will be randomized. The surgical assistant, scrub tech, and circulators can randomly choose which acellular dermal matrix product will be used "first" or "second". The ADM product that will be used first will be placed in either the left or right breast, depending on what breast the surgeon decided to perform the surgery on first. Then, the second breast that is operated on will receive whichever ADM product was not used on the first breast.

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

At the time of surgery, the surgeon will be blinded to which acellular dermal matrix product he or she is utilizing in each breast, and the technical steps of the procedure will proceed identically on each side. This can be done through the help of circulators and scrub techs during the surgery, who can randomly prepare either AlloDerm or DermACELL to be placed in either the right or left breast, without informing the surgeon. Other items, like the selection of suture and number of drains placed will be at the discretion of the surgeon but will proceed identically in the two breasts.

Patients will also be blinded as to what product is in each breast. On the day of surgery, the circulator/operating room assistants will record what product is placed in each breast in the surgery electronic medical note.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AlloDerm

AlloDerm will be surgically implanted into each participant (either in their left or right breast) at the time of their breast reconstruction surgery. AlloDERM will be placed in the breast opposite to the breast in which DermACELL is placed, so that the patient has AlloDERM in the right breast and DermACELL in the left breast, or vice versa.

Group Type ACTIVE_COMPARATOR

AlloDerm

Intervention Type OTHER

Enrolled patients will have one of their breasts reconstructed with AlloDerm at the time of their breast reconstruction surgery.

DermACELL

DermACELL will be surgically implanted into each participant (either in their left or right breast) at the time of their breast reconstruction surgery. DermACELL will be placed in the breast opposite to the breast in which AlloDERM is placed, so that the patient has AlloDERM in the right breast and DermACELL in the left breast, or vice versa.

Group Type ACTIVE_COMPARATOR

DermACELL

Intervention Type OTHER

Enrolled patients will have one of their breasts reconstructed with DermACELL at the time of their breast reconstruction surgery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AlloDerm

Enrolled patients will have one of their breasts reconstructed with AlloDerm at the time of their breast reconstruction surgery.

Intervention Type OTHER

DermACELL

Enrolled patients will have one of their breasts reconstructed with DermACELL at the time of their breast reconstruction surgery.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female patients over the age of 18
* May be undergoing either therapeutic or prophylactic mastectomy
* Must be undergoing bilateral mastectomy and breast reconstruction with tissue expanders

Exclusion Criteria

* Patients who wish to avoid the use of ADM in their reconstruction
* History of radiation of the breast
* Unilateral mastectomies
* Direct to implant breast reconstruction (not utilizing a tissue expander)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No