Phase 4
Completed N=9
Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU
Breast Cancer · Mastectomy
Source: ClinicalTrials.gov NCT01781299 ↗
Enrolled (actual)
9
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Complication Rates — 4; 3 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to assess the relative performance and complication rates between the AlloDerm RTU and SurgiMend PRS products as well as the relative economics of these two treatment options.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complication Rates |
4; 3 | — |
| SECONDARY Aesthetic Evaluation |
83.5 | — |
Eligibility Criteria
Inclusion Criteria
- Subject's with ability to provide informed consent.
- Subjects greater than 18 years old
- Subjects to undergo an immediate tissue expander reconstruction following mastectomy; and
- Subjects who are, in the opinion of the Investigator, able to understand the study, comply with the study design and are willing to return to the clinic for all the research required follow-up visits.
Exclusion Criteria
- Subjects less than 18 years of age
- Subjects that based on surgeon's discretion cannot be effectively reconstructed with the use of ADM product
- Pregnancy
- Bovine allergy
Data sourced from ClinicalTrials.gov (NCT01781299). 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. Informational only — not medical advice.