Nonsterile is not inferior
Heal et al1 conducted a prospective, noninferiority RCT to compare the incidence of infection after minor skin surgery performed by six physicians from a single general practice in Australia using sterile versus nonsterile clean gloves. They evaluated 576 consecutive patients who presented for skin excision between June 2012 and March 2013. Eighty-three patients were excluded because they had a latex allergy, were using oral antibiotics or immunosuppressive drugs, or required a skin flap procedure or excision of a sebaceous cyst. The physicians followed a standard process for performing the procedures and did not use topical antibiotics or antiseptic cleansing after the procedure.
The primary outcome was surgical site infection within 30 days of the excision, defined as purulent discharge; pain or tenderness; localized swelling, redness, or heat at the site; or a diagnosis of skin or soft-tissue infection by a general practitioner. The clinicians who assessed for infection were blinded to the patient’s assignment to the sterile or nonsterile glove group, and a stitch abscess was not counted as an infection.
The patients’ mean age was 65, and 59% were men. At baseline, there were no large differences between patients in the sterile and nonsterile glove groups in terms of smoking status, anticoagulant or corticosteroid use, diabetes, excision site, size of excision, and median days until removal of sutures. The lesions were identified histologically as nevus or seborrheic keratosis; skin cancer and precursor; or other.
The incidence of infection in the nonsterile gloves group was 21/241 (8.7%) versus 22/237 in the control group (9.3%). The confidence interval (CI; 95%) for the difference in infection rate (–0.6%) was –4.0% to 2.9%—significantly below the predetermined noninferiority margin of 7%. In a sensitivity analysis of patients lost to follow-up (15 patients, 3%) that assumed all of these patients were without infection, or with infection, the CI was still below the noninferiority margin of 7%. The per-protocol analysis showed similar results.
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