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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 is a Phase 4 study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 36 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00616824
The ClinicalTrials.gov registry entry for NCT00616824 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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