Cleft Palates — Preventing Complications in Cleft Palate Repair With Antibiotics
Citation(s)
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.
Crawford JJ, Fischer ND Oral and respiratory flora of individuals with normal and repaired palatal clefts. Cleft Palate J. 1971 Apr;8:166-76.
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
Marzoni FA, Kelly DR Bacteremia following cleft palate repair--a prospective study. Ann Plast Surg. 1983 Jun;10(6):473-4.
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
Mercer NS The use of preoperative swabs in cleft lip and palate repair. Br J Plast Surg. 2002 Mar;55(2):176-7.
Efficacy of Preoperative Prophylactic Antibiotics in Preventing Complications in the Primary Repair of Cleft Palates
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
