BridgeMD
New treatment option for Breast Reconstruction
Official title BREAST ADM Trial for Alloplastic Breast Reconstruction
ClinicalTrials.gov ID: NCT04661501
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65, women only
You may be able to join if
- 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...
You likely can't join if
- 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.
See the full eligibility 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.