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NCT00616824 · ClinicalTrials.gov registry record · Phase 4
The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction
A Phase 4 study, sponsored by Vanderbilt University Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
NCT00616824: Clinical Trial Phase 4 study, sponsored by Vanderbilt University Medical Center.
NCT00616824 is a Phase 4 study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 36 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00616824, a Phase 4 study, was terminated before completion, sponsored by Vanderbilt University Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
Study Summary
This study intends to compare postoperative outcomes of a tissue expander placement following a mastectomy with two different operative techniques. This study will be randomized and double blinded comparing the traditional placement of the tissue expander under an inferolateral serratus muscle flap to a new technique which uses an acellular dermal matrix as an inferolateral sling, instead of the muscle flap. The study we are proposing will evaluate the question of whether there is a difference between the traditional method of serratus flap and the new technique of using an acellular matrix with tissue expander placement. This will be a double blinded randomized study of thirty women in each group comparing outcomes which will include postoperative pain, complications (wound infection, hematoma, capsular contracture, etc), and patient satisfaction with the procedure.
Interventions
- PROCEDURE Dermamatrix to cover lateral aspect of tissue expander
- PROCEDURE Serratus anterior to cover lateral aspect of tissue expander
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-03 |
| Phase | Phase 4 |
Why NCT00616824 stopped before completion
NCT00616824 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Dermamatrix to cover lateral aspect of tissue expander is the first listed.
NCT00616824 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00616824 about?
NCT00616824 is a clinical study titled "The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction". This study intends to compare postoperative outcomes of a tissue expander placement following a mastectomy with two different operative techniques. This study will be randomized and double blinded comparing the traditional placement of the tissue expander under an inferolateral serratus muscle flap ...
What is the current status of trial NCT00616824?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2007-09. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00616824?
The interventions under investigation include: Dermamatrix to cover lateral aspect of tissue expander (PROCEDURE), Serratus anterior to cover lateral aspect of tissue expander (PROCEDURE).
Who is sponsoring clinical trial NCT00616824?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00616824's enrollment target sits among peer trials
36 1490th of 2000 higher than 495 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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