Comparing AlloDerm and DermACELL in Breast Reconstruction

Comparing AlloDerm and DermACELL in Breast Reconstruction: A Randomized Laterality

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.

Study Overview

• Status: Completed
• Conditions: Acellular Dermal Matrix in Breast Reconstruction
• Intervention / Treatment: Other: AlloDerm; Other: DermACELL

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Sibley Memorial Hospital
    • Washington, District of Columbia, United States, 20016
      • DAVinci Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: AlloDerm; Enrolled patients will have one of their breasts reconstructed with AlloDerm at the time of their breast reconstruction surgery.
Active Comparator: 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.	Other: DermACELL; Enrolled patients will have one of their breasts reconstructed with DermACELL at the time of their breast reconstruction surgery.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Steven P Davison, MD, Sibley Memorial Hospital

Publications and helpful links

General Publications

• Zenn MR, Salzberg CA. A Direct Comparison of Alloderm-Ready to Use (RTU) and DermACELL in Immediate Breast Implant Reconstruction. Eplasty. 2016 Aug 11;16:e23. eCollection 2016.
• Pittman TA, Fan KL, Knapp A, Frantz S, Spear SL. Comparison of Different Acellular Dermal Matrices in Breast Reconstruction: The 50/50 Study. Plast Reconstr Surg. 2017 Mar;139(3):521-528. doi: 10.1097/PRS.0000000000003048.
• Steiner CA, Weiss AJ, Barrett ML, Fingar KR, Davis PH. Trends in Bilateral and Unilateral Mastectomies in Hospital Inpatient and Ambulatory Settings, 2005-2013. 2016 Feb [updated 2016 Mar]. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #201. Available from http://www.ncbi.nlm.nih.gov/books/NBK367629/

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): July 26, 2022
• Study Completion (Actual): July 26, 2022

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB00248878

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No