Preoperative Antibiotics Study - Full Text View

Purpose

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	Intervention	Phase
Cleft Palates	Drug: Unasyn Other: saline solution	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Efficacy of Preoperative Prophylactic Antibiotics in Preventing Complications in the Primary Repair of Cleft Palates

Resource links provided by NLM:

Genetics Home Reference related topics: Crouzon syndrome branchio-oculo-facial syndrome

MedlinePlus related topics: Antibiotics Cleft Lip and Palate

Drug Information available for: Ampicillin sodium Ampicillin Ampicillin trihydrate Sulbactam Sulbactam sodium

U.S. FDA Resources

Further study details as provided by Children's Hospital of Pittsburgh:

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 ]


Enrollment:	91
Study Start Date:	May 2008
Study Completion Date:	August 2015
Primary Completion Date:	August 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. The antimicrobial coverage of Unasyn	Drug: 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 Other Names: ampicillin sulbactam
Placebo Comparator: 2 saline placebo	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

Arms

Assigned Interventions

Active Comparator: 1

Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. The antimicrobial coverage of Unasyn

Drug: 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

Other Names:

ampicillin
sulbactam

Placebo Comparator: 2

saline placebo

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

Show Detailed Description

Eligibility


Ages Eligible for Study:	3 Months to 18 Years (Child, Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760006

Locations


United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

Children's Hospital of Pittsburgh

Investigators


Principal Investigator:	Joseph Losee, MD	Children's Hospital of Pittsburgh of UPMC

More Information

Publications:

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.


Responsible Party:	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
ClinicalTrials.gov Identifier:	NCT00760006 History of Changes
Other Study ID Numbers:	07090352
Study First Received:	September 24, 2008
Last Updated:	August 6, 2015
Health Authority:	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:


Cleft Palate Jaw Abnormalities Jaw Diseases Musculoskeletal Diseases Maxillofacial Abnormalities Craniofacial Abnormalities Musculoskeletal Abnormalities Stomatognathic Diseases Mouth Abnormalities Mouth Diseases Stomatognathic System Abnormalities Congenital Abnormalities	Pharmaceutical Solutions Anti-Bacterial Agents Sulbactam Ampicillin Sultamicillin Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents Beta-Lactamase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016