Acellular Dermal Matrix in Breast Reconstruction
Conditions
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.
Interventions
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drain time | Up to 90 days | Number of days between surgical placement of drains and time until drains are removed. |
| Drain output | Up to 90 days | Total amount of fluid collected by the drains until their removal (measured in cc). |
| Incidence of Seroma | Up to 90 days | Each patient will be evaluated for incidence of seroma in either breast at postoperative visits. |
| Incidence of Infection | Up to 90 days | Each patient will be evaluated for incidence of infection in either breast at postoperative visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hematoma | Up to 90 days | Each patient will be evaluated for incidence of hematoma in either breast at postoperative visits. |
| Incidence of Device Explantation | Up to 90 days | If patients require device explantation in one breast due to complications (e.g. infection). |
| Incidence of Skin necrosis | Up to 90 days | Each patient will be evaluated for skin necrosis of either breast at postoperative visits. |
Countries
United States
Outcome results
None listed