The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction

Breast Reconstruction Clinical Trial

— REaCT-ADM  

Official title:

A Randomised Controlled Trial Comparing the Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064893
• Other study ID #: OTT 16-06
• Status: Completed
• Phase: N/A
• Start date: February 6, 2017
• Est. completion date: February 19, 2019

Study information

• Verified date: March 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 19, 2019
• Est. primary completion date: October 11, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Reconstruction

Intervention

Device:
• Alloderm
Reconstruction material
• Dermacell
Reconstruction material

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative duration of drain placements		within 6 months of initial surgery
Secondary	Episodes of seroma formation requiring aspiration		within 6 months of initial surgery
Secondary	Loss of implant		within 6 months of initial surgery
Secondary	Revisional surgery/ return to operating room		within 6 months of initial surgery
Secondary	Wound dehiscence or debridement		within 6 months of initial surgery
Secondary	Capsular contracture (as identified by the plastic surgeon)		within 6 months of initial surgery
Secondary	Number of additional postoperative clinic visits with the plastic surgeon (beyond the routine)		within 6 months of initial surgery
Secondary	Economics of total costs	Economic impact will be assessed based on calculation of total costs with each material used to include the material costs, duration of operative room use, clinic and inpatient hospital costs, surgical billing costs and anaesthesia costs	2 years