Clinical trial · Interventional
One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure
Acellular Dermal Matrix in One-Stage Breast Reconstruction: A RCT
- 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)
Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy. This procedure has been demonstrated to be oncologically safe in patients with specific criteria for early stage breast cancer. The primary drawback, however, is that it requires two separate procedures under general anesthesia and multiple office visits for expander inflation to create the breast mound. Acellular dermal matrix has gained widespread acceptance for use in breast reconstruction and other areas and has the potential to provide support to the breast implant without tissue expansion in a one-stage procedure. The purpose of the study is to test this new procedure and to evaluate the impact of one-stage breast reconstruction using acellular dermis compared to the standard two-stage expander/implant technique on measures of patient satisfaction and quality of life.
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 |
|---|---|---|---|
| One-stage dermal matrix/implant procedure | Procedure | — | UNRESOLVED |
| Two-stage tissue expander/implant procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- One-stage dermal matrix/implant
- description
- One-stage breast reconstruction with dermal matrix and implant
- interventionNames
- Procedure: One-stage dermal matrix/implant procedure
- type
- ACTIVE_COMPARATOR
- label
- Two-stage tissue expander/implant
- description
- Two-stage breast reconstruction with tissue expander and implant
- interventionNames
- Procedure: Two-stage tissue expander/implant procedure
Primary outcomes (1)
- measure
- BreastQ Quality of Life and Satisfaction Questionnaire
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who undergo immediate, implant-based reconstruction following skin-sparing and nipple-sparing mastectomy. * Patients who are older than 18 years of age and who understand English enough to complete the study questionnaires. Exclusion Criteria: * Patient refusal, patients with documented psychiatric history of psychosis or mental disorder excluding depression, patients who are active smokers. * Patients who will undergo any of the following: Autologous tissue reconstruction, patients with prior history of radiation or expected to receive post-operative radiation, patients who are pregnant, patients with grade III ptosis. * Intraoperative exclusion of those whose mastectomy flaps are deemed to be too thin or have significant ischemia.
References
Publications (1)
- DERIVEDZhong T, Temple-Oberle C, Hofer SO, Beber B, Semple J, Brown M, Macadam S, Lennox P, Panzarella T, McCarthy C, Baxter N; MCCAT Study Group. The Multi Centre Canadian Acellular Dermal Matrix Trial (MCCAT): study protocol for a randomized controlled trial in implant-based breast reconstruction. Trials. 2013 Oct 28;14:356. doi: 10.1186/1745-6215-14-356. PMID 24165392