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NCT01781299 · ClinicalTrials.gov registry record · Phase 4
Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU
A Phase 4 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 4
- Development phase
- 9
- Enrollment target
NCT01781299: Completed Phase 4 study, sponsored by University of Pittsburgh.
NCT01781299 is a Phase 4 study that has completed, run by University of Pittsburgh. The registered enrollment target is 9 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01781299, a Phase 4 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 9 participants
- Enrollment target
Study 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.
Primary Outcome
To determine the complication rate for tissue expander breast reconstruction patients using SurgiMend PRS and AlloDerm RTU ADM products. Time points include: After first procedure: 10-14 days, then 2, 4, 6, and 10 weeks after drain removal; After second procedure: 1-2 weeks, 6 weeks, 1 year, and 3 years.
Interventions
- DEVICE AlloDerm RTU
- DEVICE SurgiMend PRS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-09 |
| Phase | Phase 4 |
What the finished NCT01781299 record still lists
NCT01781299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which AlloDerm RTU is the first listed.
NCT01781299 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01781299 about?
NCT01781299 is a clinical study titled "Acellular Dermal Matrix in Tissue Expander Breast Reconstruction: A Prospective, Randomized, Clinical Trial Comparing SurgiMend PRS and AlloDerm RTU". 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.
What is the current status of trial NCT01781299?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2012-09. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01781299?
The interventions under investigation include: AlloDerm RTU (DEVICE), SurgiMend PRS (DEVICE).
Who is sponsoring clinical trial NCT01781299?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01781299's enrollment target sits among peer trials
9 1968th of 2000 higher than 29 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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