N/A
N=198
One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00956384 ↗Enrolled (actual)
198
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: BreastQ Quality of Life and Satisfaction Questionnaire — 65.32; 67.07 score on a scale — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- One-stage dermal matrix/implant procedure (Procedure); Two-stage tissue expander/implant procedure (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University Health Network, Toronto
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BreastQ Quality of Life and Satisfaction Questionnaire |
65.32; 67.07 | 0.05 |
| SECONDARY Number of Participants With Short Term Surgical Complications |
32; 27 | <0.05 sig |
| SECONDARY Number of Participants With Long Term Surgical Complications |
23; 12 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00956384). 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.