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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 is a Phase 2 study of Cleft Palates that has completed, run by Joseph Losee. The registered enrollment target is 224 participants. The trial reports 1 study location across 1 state.

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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

Conditions Studied

Interventions

  • DRUG Unasyn
  • OTHER saline solution

Study Locations (1)

Pennsylvania

  • Children's Hospital of Pittsburgh of UPMC - Pittsburgh

Trial Details

FieldValue
Enrollment Target 224 participants
Start Date 2008-05
Est. Completion 2015-08
Phase Phase 2

Sponsor

Joseph Losee

1 total trials

What the Registry Record Tells You About NCT00760006

The ClinicalTrials.gov registry entry for NCT00760006 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joseph Losee, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.