NCT04661501 BREAST ADM Trial for Alloplastic Breast Reconstruction
| NCT ID | NCT04661501 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Breast Reconstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 328 participants |
| Start Date | 2020-11-25 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 328 participants in total. It began in 2020-11-25 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a randomized single blinded prospective clinical trial comparing the surgical outcomes of four different acellular dermal matrixes (ADMs) after primary breast reconstruction. ADMs are used in conjunction with tissue expanders or breast implants to reinforce the recreated breast pocket. Currently, 4 different ADMS are commercially available: AlloDerm, DermaCell, Allomax and Flex HD. It is unclear which ADM is clinically superior. The objective of the study is to compare the complications and post-op care of 4 different ADMs within a 2 year follow up to elucidate their surgical outcomes.
Eligibility Criteria
Inclusion Criteria: * All woman aged 21 years or older but less that 65 undergoing unilateral or bilateral mastectomy with alloplastic breast reconstruction using ADM. * Breast reconstruction must be done by means of a two staged process using tissue expanders and ADM based reconstruction followed by implant tissue expander to implant exchange. Exclusion Criteria: * Patients undergoing autologous reconstruction either at the time of mastectomy or in a delayed fashion. * Patients with a history of previous breast reconstruction procedures. * Patients with prior radiation treatment to the breast or with prior mantle radiation * Any patient with a contraindication to breast reconstruction * Patients undergoing an axillary node dissection with clearance * Patients with an allergy to Polysporin or any of its ingredients. * Patients with contraindications to any of the acellular dermal matrices: • DermACELL: Allergy to Gentamicin, Vancomycin\[12\] * The surgeon performing the breast reconstruction may also deem a patient ineligible if intraoperatively, there is evidence of significant mastectomy flap ischemia prior to the initiation of the breast reconstruction procedure.
Contact & Investigator
Dr. Nancy Van Laeken
PRINCIPAL INVESTIGATOR
University of British Columbia
Frequently Asked Questions
Who can join the NCT04661501 clinical trial?
This trial is open to female participants only, aged 21 Years or older, up to 65 Years, studying Breast Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04661501 currently recruiting?
Yes, NCT04661501 is actively recruiting participants. Contact the research team at nancy@vanlaeken.com for enrollment information.
Where is the NCT04661501 trial being conducted?
This trial is being conducted at Vancouver, Canada, Vancouver, Canada, Vancouver, Canada, Vancouver, Canada.
Who is sponsoring the NCT04661501 clinical trial?
NCT04661501 is sponsored by University of British Columbia. The principal investigator is Dr. Nancy Van Laeken at University of British Columbia. The trial plans to enroll 328 participants.