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NCT05316324 · ClinicalTrials.gov registry record · Phase 3
A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction
A Phase 3 study of Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 3
- Development phase
- 353
- Enrollment target
- 2
- Study locations
NCT05316324: Active Phase 3 study of Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05316324 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 353 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05316324, a Phase 3 study of Breast Cancer, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 353 participants
- Enrollment target
- 2
- Study locations
Study Summary
The researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when ADM is not used. These complications include infections, the need for Tissue Expander (TE) or implant removal, and other conditions that lead to additional surgery.
Primary Outcome
Listed below are definitions for 90-day major complications for TEs (i.e., infection, explantation, and reoperation for any cause, including mastectomy flap necrosis): * Infection defined as: * Any event requiring the restart of antibiotics (oral or intravenous) after completion of initial perioperative antibiotics * Admission to the hospital for signs and symptoms of cellulitis (redness on breast mound) requiring antibiotics * Purulent drainage from the surgical site or incision * Explantation
Conditions Studied
Interventions
- PROCEDURE Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM)
- PROCEDURE Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM)
Study Locations (2)
New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Rockville Centre
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 353 participants |
| Start Date | 2022-03-23 |
| Est. Completion | 2027-03 |
| Phase | Phase 3 |
What the registry record for NCT05316324 still lists
NCT05316324 is an interventional study that assigns participants to a tested intervention. The registered 353 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) is the first listed.
NCT05316324 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05316324 about?
NCT05316324 is a clinical study titled "A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction". The researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when ADM is not used. These complications include infections, the need for Tissue Expander (TE) or implant...
What is the current status of trial NCT05316324?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 353 participants. The study started on 2022-03-23. Estimated completion is 2027-03.
What conditions does trial NCT05316324 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05316324?
The interventions under investigation include: Prepectoral Breast Reconstruction with Acellular Dermal Matrix (ADM) (PROCEDURE), Prepectoral Breast Reconstruction without Acellular Dermal Matrix (ADM) (PROCEDURE).
Who is sponsoring clinical trial NCT05316324?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05316324 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05316324's enrollment target sits among peer trials
353 256th of 1224 higher than 969 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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