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NCT01286168 · ClinicalTrials.gov registry record · Phase 2
Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
A Phase 2 study of Breast Cancer and Nonmalignant Breast Conditions, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 2
- Study locations
NCT01286168 is a Phase 2 study of Breast Cancer and Nonmalignant Breast Conditions that has completed, run by Mayo Clinic. The registered enrollment target is 110 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT01286168, a Phase 2 study of Breast Cancer and Nonmalignant Breast Conditions, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 2
- Study locations
Study Summary
Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of a tissue expander can be devastating and can lead to early implant loss and failed reconstruction. Surgical drains have been noted as a potential source for surgical site infections. Hypothesis: Bacteria present in surgical drains after tissue expander reconstruction may be decreased by simple and inexpensive local antiseptic interventions.
Conditions Studied
Interventions
- PROCEDURE Control
- DEVICE Sodium hypochlorite (Dakin's Solution)
- DEVICE Chlorhexidine gluconate disk
- DEVICE Occlusive Adhesive Dressing
Study Locations (2)
California
- UCSF - San Francisco
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01286168
The ClinicalTrials.gov registry entry for NCT01286168 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Control is the first listed.
NCT01286168 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Minnesota.
Frequently Asked Questions
What is clinical trial NCT01286168 about?
NCT01286168 is a clinical study titled "Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction". Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of a tissue expander can be devastating and can lead to early implant loss and failed reconstruction. Surgical drains have been noted as a potential so...
What is the current status of trial NCT01286168?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2011-05. Estimated completion is 2013-11.
What conditions does trial NCT01286168 study?
This clinical trial studies the following conditions: Breast Cancer, Nonmalignant Breast Conditions.
What interventions are being tested in trial NCT01286168?
The interventions under investigation include: Control (PROCEDURE), Sodium hypochlorite (Dakin's Solution) (DEVICE), Chlorhexidine gluconate disk (DEVICE), Occlusive Adhesive Dressing (DEVICE).
Who is sponsoring clinical trial NCT01286168?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01286168 being conducted?
This trial has 2 study locations across California, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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