Mupirocin Cream Is as Effective as Oral Cephalexin in the Treatment of Secondarily Infected Wounds

Journal of Family Practice, Dec, 1998 by Stephen J. Kraus, Lawrence J. Eron, Gerald W. Bottenfield, Margaret A. Drehobl, William D. Bushnell, Michael A. Cupo

ANTIMICROBIAL TREATMENT

Patients were randomly assigned (1:1 ratio, by computer) to receive either topical mupirocin calcium cream (2% mupirocin, SmithKline Beecham) or oral cephalexin (Keflex, Dista Products Co.) for 10 days. All patients received a placebo of the alternative dosage form. Mupirocin (or placebo cream, the emulsion base alone) was applied to cover the entire wound 3 times daily. Patients weighing more than 40 kg received cephalexin 250-mg capsules (or identical-appearing placebo capsules) 4 times daily. Patients weighing less than or equal to 40 kg received cephalexin suspension (or placebo suspension) 4 times daffy at a dosage adjusted for body weight (25 mg per kg of body weight per day). Patients were instructed to apply and gently rub the cream into the entire area with a sterile gauze sponge 3 times dally. A wound dressing could be used at the discretion of the investigator.

An assessment of compliance was performed, using patient diary cards, to ensure that patients received a minimum of 80% and a maximum of 120% of the prescribed medication doses. Pill and tube counts were also performed but were not the primary compliance measure.

EVALUATIONS

Forty-eight hours before beginning study medication, a Wright stain of wound exudate was performed by the investigator, and the SIRS score was determined. Bacteriologic specimens were obtained by lesion swabs and transported to SmithKline Beecham Clinical Laboratories (Van Nuys, Calif) for culture according to standard aerobic and anaerobic techniques as appropriate.

Patients were evaluated 3 to 5 days after the start of treatment ("on-therapy evaluation"), then 2 to 3 days after completion of therapy ("end-of-therapy evaluation"). Patients returned for follow-up clinical and bacteriologic evaluation 7 to 12 days after the end of treatment.

The primary end point was clinical response ("persistent clinical success," "clinical recurrence," or "unable to determine") which was recorded at the follow-up visit (7 to 12 days post-therapy). Persistent clinical success was defined as complete resolution or sustained improvement of signs and symptoms of infection. No exudate or pus could be present in the patient's wound, and no additional antibiotics were required for the treatment to be considered a persistent clinical success. Clinical recurrence was defined as reappearance or worsening of signs and symptoms of infection that required additional antibiotic therapy. Unable to determine was defined as the inability to make a valid assessment of clinical outcome. Results determined as failures at any point after 3 days of treatment were also considered failures at follow-up.

Bacteriologic response was determined at the follow-up visit and was assessed to be "persistent presumed eradication" if the symptomatic response was a success and a culture was not clinically indicated; "reinfection" if the pretherapy pathogen was eradicated but one or more new pathogens appeared during the follow-up period; "relapse" if the initial pathogen was eliminated during therapy but reemerged during the follow-up period; or "unable to determine" if bacteriologic evaluation could not be made. Patients were evaluated for bacteriologic efficacy if a pretherapy pathogen had been isolated and they were clinically evaluable.