Clinical trial · Interventional
Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction
Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction: A Blinded, Prospective, Randomized, Controlled Trial
NCT01310075CI-TRIAL-00038373completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alloderm | Device | — | UNRESOLVED |
| Surgimend | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Alloderm Mesh
- description
- 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.
- interventionNames
- Device: Alloderm
- type
- EXPERIMENTAL
- label
- Surgimend Mesh
- description
- Surgimend Mesh - 10 x 15 cm piece of fenestrated material is sewn to the fold, curved side along the fold, using vicryl suture.
- interventionNames
- Device: Surgimend
- type
- NO_INTERVENTION
- label
- Control (no mesh)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients undergoing immediate tissue expander reconstruction following mastectomy by any of the surgeon co-investigators are eligible for the study. 2. Patients 18 years of age or older are eligible for the study. 3. Patients undergoing skin-sparing mastectomy utilizing bioprosthetic mesh are eligible for the study. 4. Patients who have not undergone autologous tissue breast reconstruction and intend to undergo implant only breast reconstruction. 5. Patients who intend to remain under the MDACC surgeon's care until completion of the reconstruction. Exclusion Criteria: 1. Patients with prior radiation to the breast/chest wall of the ipsilateral breast . 2. Patients who cannot be effectively reconstructed without the use of bioprosthetic mesh. 3. Patients who are current smokers. 4. Patients requiring additional intra-operative skin resections of greater than 1cm beyond the skin edge as a result of mastectomy flap devascularization. 5. Patients who have a history of breast tissue expander or implant placement.
References
Publications (0)
Data not yet available
No reference posted for this study.