Clinical trial · Interventional
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy
Clinical Study Comparing Two-Stage Breast Reconstruction Following Mastectomy With and Without the Use of SurgiMend® PRS Fetal Bovine Collagen Matrix in Patients With Pre-Mastectomy Radiation Therapy
NCT01959867CI-TRIAL-00025427withdrawnN/AClinicalTrials.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)
This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.
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 |
|---|---|---|---|
| No Intervention | Other | — | UNRESOLVED |
| SurgiMend® PRS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SurgiMend® PRS (ADM)
- description
- Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).
- interventionNames
- Device: SurgiMend® PRS
- type
- OTHER
- label
- No Intervention
- description
- Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion).
- interventionNames
- Other: No Intervention
Primary outcomes (2)
- measure
- Capsular Contracture Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient is at least 18 years of age * Patient is female * Patient is undergoing immediate, two-stage breast reconstruction following mastectomy with or without the use of SurgiMend® PRS * Patient has previously undergone pre-mastectomy XRT for breast cancer, with lumpectomy or partial mastectomy, with the previously irradiated breast now being reconstructed (with or without contralateral mastectomy \& reconstruction) * Patient utilized a textured expander only * Patient utilized a smooth gel permanent implant only * Patient has agreed and is able to comply with the study follow-up requirements * Patient or guardian has provided consent for participation Exclusion Criteria: * Patient is undergoing single-stage breast reconstruction * Patient is undergoing a delayed reconstruction * Patient is undergoing reconstruction using a smooth tissue expander, textured gel breast implant or any saline breast implant. * Patient is undergoing planned reconstruction using autologous tissue * Patient has a known hypersensitivity to collagen or bovine derived materials * Patient is currently pregnant, nursing, or planning a pregnancy during the course of the study * Patient who has had pre-mastectomy XRT bilaterally for breast cancer (either at the same time or separated in time)
References
Publications (0)
Data not yet available
No reference posted for this study.