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Comparing AlloDerm and DermACELL in Breast Reconstruction

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT04710537
Collaborator
(none)
50
Enrollment
2
Locations
2
Arms
9.1
Actual Duration (Months)
25
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: AlloDerm
  • Other: DermACELL
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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.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.
Masking:
Double (Participant, Care Provider)
Masking Description:
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.
Primary Purpose:
Other
Official Title:
Comparing AlloDerm and DermACELL in Breast Reconstruction: A Randomized Laterality
Actual Study Start Date :
Oct 21, 2021
Actual Primary Completion Date :
Jul 26, 2022
Actual Study Completion Date :
Jul 26, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Drain time [Up to 90 days]

    Number of days between surgical placement of drains and time until drains are removed.

  2. Drain output [Up to 90 days]

    Total amount of fluid collected by the drains until their removal (measured in cc).

  3. Incidence of Seroma [Up to 90 days]

    Each patient will be evaluated for incidence of seroma in either breast at postoperative visits.

  4. Incidence of Infection [Up to 90 days]

    Each patient will be evaluated for incidence of infection in either breast at postoperative visits.

Secondary Outcome Measures

  1. Incidence of Skin necrosis [Up to 90 days]

    Each patient will be evaluated for skin necrosis of either breast at postoperative visits.

  2. Incidence of Hematoma [Up to 90 days]

    Each patient will be evaluated for incidence of hematoma in either breast at postoperative visits.

  3. Incidence of Device Explantation [Up to 90 days]

    If patients require device explantation in one breast due to complications (e.g. infection).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 DAVinci Plastic Surgery Washington District of Columbia United States 20016
2 Sibley Memorial Hospital Washington District of Columbia United States 20016

Sponsors and Collaborators

  • Johns Hopkins University

Investigators

  • Principal Investigator: Steven P Davison, MD, Sibley Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04710537
Other Study ID Numbers:
  • IRB00248878
First Posted:
Jan 14, 2021
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 4, 2022