Comparing AlloDerm and DermACELL in Breast Reconstruction

Acellular Dermal Matrix in Breast Reconstruction Clinical Trial

Official title:

Comparing AlloDerm and DermACELL in Breast Reconstruction: A Randomized Laterality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04710537
• Other study ID #: IRB00248878
• Status: Completed
• Phase: N/A
• Start date: October 21, 2021
• Est. completion date: July 26, 2022

Study information

• Verified date: August 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 26, 2022
• Est. primary completion date: July 26, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acellular Dermal Matrix in Breast Reconstruction

Intervention

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

Locations

Country	Name	City	State
United States	DAVinci Plastic Surgery	Washington	District of Columbia
United States	Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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 1]. 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/ — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drain time	Number of days between surgical placement of drains and time until drains are removed.	Up to 90 days
Primary	Drain output	Total amount of fluid collected by the drains until their removal (measured in cc).	Up to 90 days
Primary	Incidence of Seroma	Each patient will be evaluated for incidence of seroma in either breast at postoperative visits.	Up to 90 days
Primary	Incidence of Infection	Each patient will be evaluated for incidence of infection in either breast at postoperative visits.	Up to 90 days
Secondary	Incidence of Skin necrosis	Each patient will be evaluated for skin necrosis of either breast at postoperative visits.	Up to 90 days
Secondary	Incidence of Hematoma	Each patient will be evaluated for incidence of hematoma in either breast at postoperative visits.	Up to 90 days
Secondary	Incidence of Device Explantation	If patients require device explantation in one breast due to complications (e.g. infection).	Up to 90 days