Clinical trial · Observational
Immediate Postmastectomy Breast Reconstruction (Strattice Breast)
A Multicenter, Prospective, Open-Label Study to Assess the Clinical Outcomes of LTM Use in Two-Stage Breast Reconstruction Immediately Post Mastectomy
NCT00619762CI-TRIAL-00024746completedResults 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)
This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM product in three planned analyses. The primary objective of this study is to prospectively assess the clinical outcomes associated with the use of LTM in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LTM - a porcine-based surgical mesh | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Histology Sample Evaluations Assessing Incorporation of StratticeTM Reconstructive Tissue Matrix
- timeFrame
- At the time of expander/implant exchange (Stage II),
- description
- Evaluation of 3 histology parameters, fibroblast infiltration, immune cell response \& revascularization, expressed as frequency distributions. Samples evaluated for presence of fibroblasts (cellularity), neovascularization \& immune cell response using 4 pt scale. Fibroblast Infiltration: 1=None,2=Few,sparse,3=Moderate,4=Dense. Revascularization:1=None,2=Few randomly dispersed capillaries,3=Moderate; mostly homogenous distribution of new vessels,4=Significant,uniformly distributed vessels; both capillaries and arterioles. Immune Cell response: 1= None,2=Few,normal healing response,3=Moderate,4=Significant;above expected presence for healing. 4 high power(HP)fields reviewed \& if uniform in appearance/cellular distribution, 4 considered representative of sample as a whole. If non-uniform distribution observed, 3 HP fields of "sparse or light" distribution \& 3 HP fields of dense distribution counted \& results averaged. Tissue sample then assessed for overall acellularity \& expressed as %.
Secondary outcomes (1)
- measure
- Severity of Local Inflammation at and Around the Surgical Site
- timeFrame
- Postoperative Day 7, 14, 21, 30 days
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A candidate for immediate, two-stage breast reconstruction using LTM following a skin sparing mastectomy * An ASA Physical Status Classification5 of 1 or 2 (see App I) * Estimated life expectancy \> 1 year Exclusion Criteria: * Clinically significant systemic disease * Received inductive chemo-therapy within 2 months prior to mastectomy or radiation therapy to the region at any time * Predicted excised breast mass of \>750 gms * Co-morbid factors which predispose to postoperative infection, such as insulin dependent diabetes, smoking, chronic steroid use, malnourishment, or co-existent infection * Need for tissue flap in addition to expander * History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction * Enrollment or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial * Any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate
References
Publications (0)
Data not yet available
No reference posted for this study.