Comparing AlloDerm and DermACELL in Breast Reconstruction

NCT04710537 | Completed

• 1 other identifier: IRB00248878
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Acellular Dermal Matrix in Breast Reconstruction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Incidence of Skin necrosis

  Up to 90 days

• Incidence of Hematoma

  Up to 90 days

• Incidence of Device Explantation

  Up to 90 days

Study Arms (2)

AlloDerm

ACTIVE COMPARATOR

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

DermACELL

ACTIVE COMPARATOR

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

Interventions

AlloDerm OTHER

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

AlloDerm

DermACELL OTHER

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

DermACELL

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cis-women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

DAVinci Plastic Surgery

Washington D.C., District of Columbia, 20016, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Related Publications (3)

• 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.

  PMID: 27602176 BACKGROUND

• 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.

  PMID: 28234811 BACKGROUND

• 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/

  PMID: 27253008 BACKGROUND

MeSH Terms

Interventions

Alloderm

Study Officials

• Steven P Davison, MD

  Sibley Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 14, 2021
• Study Start: October 21, 2021
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)