Preventing Complications in Cleft Palate Repair With Antibiotics
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|ClinicalTrials.gov Identifier: NCT00760006|
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : February 1, 2018
Last Update Posted : February 1, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Cleft Palates||Drug: Unasyn Other: saline solution||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Efficacy of Preoperative Prophylactic Antibiotics in Preventing Complications in the Primary Repair of Cleft Palates|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Active Comparator: Unasyn Antibiotic Arm
Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. All subjects enrolled in the study will receive a single dose of antibiotic or saline solution (placebo control) intravenously, as the IV will already be in place as standard of care for surgery. The study aims to assess the efficacy of the prophylactic antibiotic in cleft surgery to: decrease the incidence of surgical site infections, speed the progression of postoperative healing, improve the final quality of wound healing achieved, and decrease the rate of palatal fistula formation.
Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure. The FDA approved antibiotic used for this study is Unasyn. Unasyn is a first-line measure, used by ENT surgeons at Children's Hospital of Pittsburgh for antibiotic treatment of virtually all ear, nose and throat infections. The use of Unasyn for this study is off-label as with the majority of antibiotics used with children. Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm
Placebo Comparator: Saline Placebo Arm
Saline Placebo. All subjects enrolled in the study will receive a single dose of antibiotic or saline solution (placebo control) intravenously, as the IV will already be in place as standard of care for surgery. This will act as the placebo control.
Other: saline solution
Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm.
Other Name: Salt solution
- Number of Participants With Fistula or Delayed Wound Healing Following Palatoplasty [ Time Frame: We anticipate a minimum of less than 2 months to a maximum of 1 year for follow-up will be necessary to document either stage 1 healing or the presence of a palatal fistula in nearly all cases. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760006
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Joseph Losee, MD||University of Pittsburgh|