drugset / Trial / NCT00760006
Preventing Complications in Cleft Palate Repair With Antibiotics
RandomizedParallel-groupTriple-blindTreatment
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
Timeline
- Start
- 2008-05
- Primary completion
- 2015-08
- Completion
- 2015-08
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ampicillin | Unknown | 50 mg/kg | Intravenous |