Preventing Complications in Cleft Palate Repair With Antibiotics

NCT00760006 | Completed Phase 2 Results DMC

• 1 other identifier: 07090352
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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

Conditions

Cleft Palates

Keywords

cleft secondary palate; primary closure of secondary cleft palate; Prophylactic Antibiotics; Unasyn; Cleft Palate

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Fistula or Delayed Wound Healing Following Palatoplasty

  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.

  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.

Study Arms (2)

Unasyn Antibiotic Arm

ACTIVE COMPARATOR

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

Saline Placebo Arm

PLACEBO COMPARATOR

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

Interventions

Unasyn DRUG

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

Also known as: ampicillin, sulbactam

Unasyn Antibiotic Arm

saline solution OTHER

Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm.

Also known as: Salt solution

Saline Placebo Arm

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Joseph Losee: lead

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (8)

• 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.

  PMID: 16397457 BACKGROUND

• 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. doi: 10.1597/03-108.1.

  PMID: 15865461 BACKGROUND

• Mercer NS. The use of preoperative swabs in cleft lip and palate repair. Br J Plast Surg. 2002 Mar;55(2):176-7. doi: 10.1054/bjps.2001.3776. No abstract available.

  PMID: 11987971 BACKGROUND

• JOLLEYS A, SAVAGE JP. Healaing defects in cleft palate surgery--the role of infection. Br J Plast Surg. 1963 Apr;16:134-9. doi: 10.1016/s0007-1226(63)80094-6. No abstract available.

  PMID: 13957936 BACKGROUND

• JACKSON DM, LOWBURY EJ, TOPLEY E. Chemotherapy of Streptococcus pyogenes infection of burns. Lancet. 1951 Oct 20;2(6686):705-11. doi: 10.1016/s0140-6736(51)91478-x. No abstract available.

  PMID: 14874485 BACKGROUND

• 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

  BACKGROUND

• Marzoni FA, Kelly DR. Bacteremia following cleft palate repair--a prospective study. Ann Plast Surg. 1983 Jun;10(6):473-4. doi: 10.1097/00000637-198306000-00006.

  PMID: 6881863 BACKGROUND

• Crawford JJ, Fischer ND. Oral and respiratory flora of individuals with normal and repaired palatal clefts. Cleft Palate J. 1971 Apr;8:166-76. No abstract available.

  PMID: 5283309 BACKGROUND

MeSH Terms

Conditions

Cleft Palate

Interventions

sultamicillin; Ampicillin; Sulbactam; Saline Solution

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Joseph E. Losee
• Organization: Chilsren's Hospital of Pittsburgh of UPMC

joseph.losee@chp.edu

412-692-6203

Study Officials

• Joseph Losee, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ross H. Musgrave Professor of Pediatric Plastic Surgery Executive Vice-Chair and Program Director Department of Plastic Surgery University of Pittsburgh Medical Center

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: May 1, 2008
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 1, 2018
• Results First Posted: February 1, 2018

Record last verified: 2018-01

Locations

US (1)