Preoperative Antibiotics Study
Verified July 2013 by Children's Hospital of Pittsburgh
Information provided by (Responsible Party):
Joseph E. Losee, Children's Hospital of Pittsburgh
First received: September 24, 2008
Last updated: July 29, 2013
Last verified: July 2013
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
Other: saline solution
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||Efficacy of Preoperative Prophylactic Antibiotics in Preventing Complications in the Primary Repair of Cleft Palates
Primary Outcome Measures:
- The study aims to assess the efficacy of prophylactic antibiotics in cleft surgery. [ 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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. [ Time Frame: We anticipate a minimum of less than 2 months to a maximum of 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2014 (Final data collection date for primary outcome measure)
Active Comparator: 1
Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. The antimicrobial coverage of Unasyn
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: 2
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
|Ages Eligible for Study:
||3 Months to 18 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Children diagnosed as having cleft palates undergoing palatoplasty between the ages of 3 months and 18 years will be included in this study. Palatoplasty is the current standard of care in the sequence of treatment for cleft secondary palates. Pediatric plastic surgeons work primarily with children, and have undergone extensive training during their residencies and pediatric surgical fellowships to do so. Children will be evaluated initially at the Cleft-Craniofacial Center at the Children's Hospital of Pittsburgh of UPMC, which is set up to accommodate children of all ages and their families. Approximately 300 children will be required to contribute to a meaningful analysis.
- All patients requiring prophylactic antibiotics for spontaneous bacterial endocarditis, with documented allergic reactions to the ampicillin-sulbactam, and with known immunodeficiencies or immunodeficiency associated syndromes, such as the 22q chromosomal deletion, will be excluded from study participation.
- Selection will be based on the parent's willingness to allow their child to participate in the study.
- Children already receiving antibiotics at the time of their surgery will be evaluated distinctly, though they will not be included in the antibiotic or the placebo groups
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00760006
Children's Hospital of Pittsburgh
||Joseph Losee, MD
||Children's Hospital of Pittsburgh of UPMC
1. Centers for Disease Control and Prevention (CDC). Improved National prevalence estimates for 18 selected major birth defects—Unites States, 1999-2001. MMWR Morb Mortal Wkly Rep. 2006; 54:1301-1305. 2. Chuo CB, Timmons MJ. The bacteriology of children before primary cleft lip and palate surgery. The Cleft Palate-Craniofac J. 2005; 42:272-276. 3. Mercer NSG. The use of preoperative swabs in cleft lip and palate repair [letter to the editor]. Br J Plast Surg. 2002; 55:176-177. 4. Jolleys A, Savage JP. Healing defects in cleft palate surgery-the role of infection. Br J Plast Surg. 1963; 16:134-139. 5. Lowbury EJL. Infection of Burns. Proc Soc Med. 1954; 47:231-232. 6. Jackson DM, Lowbury EJL, Topley E. Chemotherapy of Streptococcus pyogenes infection of burns. Lancet. 1951; 2:705-711. 7. McClelland RMA, Patterson TJS. The influence of penicillin on the complication rate after repair of clefts of the lip and palate. Br J Plast Surg. 1963; 16:144-145. 8. Marzoni FA, Kelly DR. Bacteraemia following cleft palate repair-a prospective study. Ann Plast Surg. 1983; 10:473-474. 9. Crawford JJ, Fischer ND. Oral and respiratory flora of individuals with normal and repaired palatal clefts. Cleft Palate J. 1971; 8:166-176.
||Joseph E. Losee, Ross H. Musgrave Professor of Pediatric Plastic Surgery Executive Vice-Chair and Program Director Department of Plastic Surgery University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 24, 2008
||July 29, 2013
||United States: Institutional Review Board
Keywords provided by Children's Hospital of Pittsburgh:
cleft secondary palate
Patients undergoing primary closure of a cleft secondary palate
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 26, 2015
Stomatognathic System Abnormalities