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

Sponsor:

Information provided by (Responsible Party):

Joseph Losee, University of Pittsburgh

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Cleft Palates	Drug: Unasyn Other: saline solution	Phase 2

Show Detailed Description

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	224 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Cleft Lip and Palate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.	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: 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

Arm

Intervention/treatment

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.

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: 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

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	3 Months to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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

Locations


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

Sponsors and Collaborators

Joseph Losee

Investigators


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

More Information

Publications:

Centers for Disease Control and Prevention (CDC). Improved national prevalence estimates for 18 selected major birth defects--United States, 1999-2001. MMWR Morb Mortal Wkly Rep. 2006 Jan 6;54(51):1301-5.

Chuo CB, Timmons MJ. The bacteriology of children before primary cleft lip and palate surgery. Cleft Palate Craniofac J. 2005 May;42(3):272-6.

Mercer NS. The use of preoperative swabs in cleft lip and palate repair. Br J Plast Surg. 2002 Mar;55(2):176-7.

JOLLEYS A, SAVAGE JP. Healaing defects in cleft palate surgery--the role of infection. Br J Plast Surg. 1963 Apr;16:134-9.

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

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

Marzoni FA, Kelly DR. Bacteremia following cleft palate repair--a prospective study. Ann Plast Surg. 1983 Jun;10(6):473-4.

Crawford JJ, Fischer ND. Oral and respiratory flora of individuals with normal and repaired palatal clefts. Cleft Palate J. 1971 Apr;8:166-76.


Responsible Party:	Joseph Losee, Ross H. Musgrave Professor of Pediatric Plastic Surgery Executive Vice-Chair and Program Director Department of Plastic Surgery University of Pittsburgh Medical Center, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00760006 History of Changes
Other Study ID Numbers:	07090352
First Posted:	September 25, 2008 Key Record Dates
Results First Posted:	February 1, 2018
Last Update Posted:	February 1, 2018
Last Verified:	January 2018

Keywords provided by Joseph Losee, University of Pittsburgh:


cleft secondary palate primary closure of secondary cleft palate Prophylactic Antibiotics Unasyn Cleft 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 Ampicillin Sulbactam Sultamicillin Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents beta-Lactamase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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