Comparing AlloDerm and DermACELL in Breast Reconstruction

Not Applicable

Completed

• Conditions: Acellular Dermal Matrix in Breast Reconstruction
• Interventions: Other: AlloDerm; Other: DermACELL

• Registration Number: NCT04710537
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-14
• Study Start: 2021-10-21
• Primary Completion: 2022-07-26
• Study Completion: 2022-07-26
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AlloDerm	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.
DermACELL	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Seroma	Up to 90 days	Each patient will be evaluated for incidence of seroma in either breast at postoperative visits.
Incidence of Infection	Up to 90 days	Each patient will be evaluated for incidence of infection in either breast at postoperative visits.
Drain time	Up to 90 days	Number of days between surgical placement of drains and time until drains are removed.
Drain output	Up to 90 days	Total amount of fluid collected by the drains until their removal (measured in cc).

Secondary Outcome Measures

Name	Time	Method
Incidence of Hematoma	Up to 90 days	Each patient will be evaluated for incidence of hematoma in either breast at postoperative visits.
Incidence of Skin necrosis	Up to 90 days	Each patient will be evaluated for skin necrosis of either breast at postoperative visits.
Incidence of Device Explantation	Up to 90 days	If patients require device explantation in one breast due to complications (e.g. infection).

Trial Locations

Locations (2)

DAVinci Plastic Surgery; 🇺🇸 Washington, District of Columbia, United States

Sibley Memorial Hospital; 🇺🇸 Washington, District of Columbia, United States