Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction: A Blinded, Prospective, Randomized, Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Number of Participants With Complications After Tissue Expander Replacement With Implant
Study Overview
Brief Summary
The goal of this clinical research study is to learn if the complication rate and post-surgical appearance differ based on what type of mesh is used for breast reconstruction surgery.
Detailed Description
If you agree to take part in this study, you will be randomly assigned (as in the roll of a dice) to receive Surgimend mesh or Alloderm mesh.
Breast Reconstruction Surgery:
All techniques of the breast reconstruction surgery are considered to be standard of care. You will be given a separate consent form to sign that explains the procedure and risks in more detail.
Data Collection:
Information about you will be collected, including your age, height, weight, breast size, past medical and smoking history, tumor size and location, and the surgical method used for the breast reconstruction surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing immediate tissue expander reconstruction following mastectomy by any of the surgeon co-investigators are eligible for the study.
- •Patients 18 years of age or older are eligible for the study.
- •Patients undergoing skin-sparing mastectomy utilizing bioprosthetic mesh are eligible for the study.
- •Patients who have not undergone autologous tissue breast reconstruction and intend to undergo implant only breast reconstruction.
- •Patients who intend to remain under the MDACC surgeon's care until completion of the reconstruction.
Exclusion Criteria
- •Patients with prior radiation to the breast/chest wall of the ipsilateral breast .
- •Patients who cannot be effectively reconstructed without the use of bioprosthetic mesh.
- •Patients who are current smokers.
- •Patients requiring additional intra-operative skin resections of greater than 1cm beyond the skin edge as a result of mastectomy flap devascularization.
- •Patients who have a history of breast tissue expander or implant placement.
Arms & Interventions
Alloderm Mesh
Alloderm Mesh - 6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the implant.
Intervention: Alloderm (Device)
Surgimend Mesh
Surgimend Mesh - 10 x 15 cm piece of fenestrated material is sewn to the fold, curved side along the fold, using vicryl suture.
Intervention: Surgimend (Device)
Control (no mesh)
Outcomes
Primary Outcomes
Number of Participants With Complications After Tissue Expander Replacement With Implant
Time Frame: through study completion, an average of 1 year
Secondary Outcomes
No secondary outcomes reported