Clinical trial NCT03064893: The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction
Official title: A Randomised Controlled Trial Comparing the Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Reconstruction
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to breast cancer patients and is considered an integral part of breast cancer treatment. In general, breast reconstruction can be accomplished using the patients own tissues or implantable prosthetic devices. Various acellular dermal matrices (ADMs) are offered on the market and the costs vary widely despite very similar qualities. The two most commonly used ADM products in North America by far are Dermacell and Alloderm. The difference between the two products include a) level of sterility, with Dermacell being sterilized to 10-9 while Alloderm is sterilized to 10-6 and b) the consistency and thickness of the biologic material and c) a significant different in cost ($2200 CAD vs $3600, respectively). Each product has shown to be safe and effective. As such, clinical equipoise exists. This will be a pragmatic trial to evaluate Dermacell with Alloderm in a head to head randomized fashion, with regards to the postoperative complications, namely infection, seroma formation (as measured by drain duration and output), loss of implant, incidence of revisional surgery and capsular contracture.


Eligibility criteria: Inclusion Criteria:

* Female patient
* Ages 20-90
* All patients undergoing mastectomy for breast cancer or prophylaxis for breast cancer with immediate implant-based reconstruction
* Able to provide verbal consent

Exclusion Criteria:

* Patients who have had prior chest wall or irradiation on the reconstructed side
* Patients not undergoing immediate breast reconstruction at the time of mastectomy
* Any patient with a contraindication to immediate breast reconstruction

Primary outcomes:
measure: Postoperative duration of drain placements
timeFrame: within 6 months of initial surgery
Secondary outcomes:
measure: Episodes of seroma formation requiring aspiration
timeFrame: within 6 months of initial surgery
measure: Loss of implant
timeFrame: within 6 months of initial surgery
measure: Revisional surgery/ return to operating room
timeFrame: within 6 months of initial surgery
measure: Wound dehiscence or debridement
timeFrame: within 6 months of initial surgery
measure: Capsular contracture (as identified by the plastic surgeon)
timeFrame: within 6 months of initial surgery
measure: Number of additional postoperative clinic visits with the plastic surgeon (beyond the routine)
timeFrame: within 6 months of initial surgery
measure: Economics of total costs
timeFrame: 2 years
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Angel Arnaout, MD
role: PRINCIPAL_INVESTIGATOR
References: