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NCT01244698 · ClinicalTrials.gov registry record · Phase 4
Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction
A Phase 4 study, sponsored by Stony Brook University.
- Completed
- Registry status
- Phase 4
- Development phase
- 132
- Enrollment target
NCT01244698 is a Phase 4 study that has completed, run by Stony Brook University. The registered enrollment target is 132 participants.
The verdict
NCT01244698, a Phase 4 study, has completed, sponsored by Stony Brook University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 132 participants
- Enrollment target
Study Summary
Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction. The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration.
Interventions
- DRUG Cefadroxil discontinued early
- DRUG Cefadroxil until drain removal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2010-11 |
| Est. Completion | 2014-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01244698
The ClinicalTrials.gov registry entry for NCT01244698 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stony Brook University, which has 127 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cefadroxil discontinued early is the first listed.
NCT01244698 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01244698 about?
NCT01244698 is a clinical study titled "Postoperative Antibiotic Requirements Following Immediate Breast Reconstruction". Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgi...
What is the current status of trial NCT01244698?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 132 participants. The study started on 2010-11. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01244698?
The interventions under investigation include: Cefadroxil discontinued early (DRUG), Cefadroxil until drain removal (DRUG).
Who is sponsoring clinical trial NCT01244698?
This trial is sponsored by Stony Brook University, which has 127 total clinical trials registered on ClinicalTrials.gov.
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