Clinical trial NCT04710537: Comparing AlloDerm and DermACELL in Breast Reconstruction
Official title: Comparing AlloDerm and DermACELL in Breast Reconstruction: A Randomized Laterality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acellular Dermal Matrix in Breast Reconstruction
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Drain time
timeFrame: Up to 90 days
measure: Drain output
timeFrame: Up to 90 days
measure: Incidence of Seroma
timeFrame: Up to 90 days
measure: Incidence of Infection
timeFrame: Up to 90 days
Secondary outcomes:
measure: Incidence of Skin necrosis
timeFrame: Up to 90 days
measure: Incidence of Hematoma
timeFrame: Up to 90 days
measure: Incidence of Device Explantation
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: Washington
country: United States
facility: DAVinci Plastic Surgery
state: District of Columbia
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
Study officials:
affiliation: Sibley Memorial Hospital
name: Steven P Davison, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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]. 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/