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NCT00760006 · ClinicalTrials.gov registry record · Phase 2
Preventing Complications in Cleft Palate Repair With Antibiotics
A Phase 2 study of Cleft Palates, sponsored by Joseph Losee.
- Completed
- Registry status
- Phase 2
- Development phase
- 224
- Enrollment target
- 1
- Study location
NCT00760006: Completed Phase 2 study of Cleft Palates, sponsored by Joseph Losee.
NCT00760006 is a Phase 2 study of Cleft Palates that has completed, run by Joseph Losee. The registered enrollment target is 224 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00760006, a Phase 2 study of Cleft Palates, has completed, sponsored by Joseph Losee.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 224 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to determine the efficacy of administering a single dose of preoperative antibiotics to prevent complications in patients undergoing primary closure of a cleft secondary palate. Secondary objective of this study is to evaluate the effects of preoperative antibiotics administered on post operative outcome following primary closure of cleft secondary palate. The study aims to assess the efficacy of prophylactic antibiotics in cleft surgery to * decrease the incidence of surgical sight infections * speed the progression of postoperative healing * improve the final quality of wound healing achieved * decrease the rate of palatal fistula formation
Primary Outcome
Primary outcomes of fistula or delayed wound healing following palatoplasty were measured in two groups of patients. This outcome measure addresses both objectives noted in the summary of the study description.
Conditions Studied
Interventions
- DRUG Unasyn
- OTHER saline solution
Study Locations (1)
Pennsylvania
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2008-05 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
What the finished NCT00760006 record still lists
NCT00760006 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% higher).
The record links to 1 condition, with Cleft Palates appearing as the primary indexed condition, and to 2 interventions - of which Unasyn is the first listed.
NCT00760006 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00760006 about?
NCT00760006 is a clinical study titled "Preventing Complications in Cleft Palate Repair With Antibiotics". The primary objective of this study is to determine the efficacy of administering a single dose of preoperative antibiotics to prevent complications in patients undergoing primary closure of a cleft secondary palate. Secondary objective of this study is to evaluate the effects of preoperative antibi...
What is the current status of trial NCT00760006?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 224 participants. The study started on 2008-05. Estimated completion is 2015-08.
What conditions does trial NCT00760006 study?
This clinical trial studies the following conditions: Cleft Palates.
What interventions are being tested in trial NCT00760006?
The interventions under investigation include: Unasyn (DRUG), saline solution (OTHER).
Who is sponsoring clinical trial NCT00760006?
This trial is sponsored by Joseph Losee, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00760006 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00760006's enrollment target sits among peer trials
224 269th of 2000 higher than 1,727 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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