PRACTICE CHANGER
Consider using non-sterile gloves during minor skin excisions (even those that require sutures) because the infection rate is not increased compared to using sterile gloves.1
Strength of recommendation
B: Based on a randomized controlled trial done in a primary care practice.
Heal C, Sriharan S, Buttner PG, et al. Comparing non-sterile to sterile gloves for minor surgery: a prospective randomized controlled noninferiority trial. Med J Aust. 2015;202:27-31.
Illustrative case
A 50-year-old man comes to your office to have a mole removed from his arm. You decide to excise the lesion in your office today. Do you need to use sterile gloves for this procedure, or can you use gloves from the clean non-sterile box in the exam room?
Non-sterile gloves are readily available during a typical office visit and cost up to a dollar less per pair than sterile gloves.1-3 Studies conducted in settings other than primary care offices have shown that non-sterile gloves do not increase the risk of infection during several types of minor skin procedures.
A partially blinded, randomized controlled trial (RCT) in an emergency department found no significant difference in infection rates between the use of sterile (6.1%) vs non-sterile (4.4%) gloves during laceration repairs.2 Similarly, a small RCT in an outpatient dermatology clinic and a larger prospective trial by a Mohs dermatologist showed that infection rates were not increased after Mohs surgery using non-sterile (0.49%) vs sterile (0.50%) gloves.3,4
Guidelines on the use of sterile vs non-sterile gloves for minor skin excisions in outpatient primary care are difficult to come by. Current guidelines from the Centers for Disease Control and Prevention (CDC) and other agencies regarding surgical site infections are broad and focus on the operating room environment.5-7
The American Academy of Dermatology is working on a guideline for treatment of non-melanoma skin cancer that’s due out this winter, and this may provide additional guidance.8 A 2003 review instructed primary care physicians to use sterile gloves for excisional skin biopsies that require sutures.9
The 2015 study by Heal et al1 appears to be the first RCT to address the question of sterile vs non-sterile glove use for minor skin excisions in a primary care outpatient practice.
STUDY SUMMARY: Non-sterile gloves are not inferior to sterile gloves
Heal et al1 conducted a prospective, randomized, controlled, noninferiority trial to compare the incidence of infection after minor skin surgery performed by 6 physicians from a single general practice in Australia using sterile vs non-sterile 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 or 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 non-sterile glove group, and a stitch abscess was not counted as an infection.
The patients’ mean age was 65 years and 59% were men. At baseline, there were no large differences between patients in the sterile and non-sterile glove groups in terms of smoking status, anticoagulant or steroid 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 non-sterile gloves group was 21/241 (8.7%; 95% confidence interval [CI], 4.9%-12.6%) vs 22/237 in the control group (9.3%; 95% CI, 7.4%-11.1%). The CI (95%) for the difference in infection rate (-0.6%) was -4.0% to 2.9%. This was 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.
WHAT'S NEW: New evidence questions the need for sterile gloves for in-office excisions
Heal et al1 demonstrated that in a primary care setting, non-sterile gloves are not inferior to sterile gloves for performing excisional procedures that require sutures. While standard practice has many family physicians using sterile gloves for these procedures, this study promotes changing this behavior.
