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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: Completed Phase 4 study, sponsored by Stony Brook University.
NCT01244698 is a Phase 4 study that has completed, run by Stony Brook University. The registered enrollment target is 132 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
One or more of the following: 1. Purulent drainage, with or without laboratory confirmation, from the superficial incision. 2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision. 3. At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless incision is culture-negative. 4. Diagnosis of superficial incisional SSI by t
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 |
What the finished NCT01244698 record still lists
NCT01244698 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Cefadroxil discontinued early is the first listed.
NCT01244698 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01244698's enrollment target sits among peer trials
132 610th of 2000 higher than 1,382 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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