N/A
N=90
Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01310075 ↗Enrolled (actual)
90
Serious AEs
7.6%
Results posted
Apr 2019
Primary outcome: Primary: Number of Participants With Complications After Tissue Expander Replacement With Implant — 10; 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alloderm (Device); Surgimend (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complications After Tissue Expander Replacement With Implant |
10; 10 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01310075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.