A double blind randomized controlled trial using copper impregnated maternity sanitary towels to reduce perineal wound infection.

ABSTRACT

OBJECTIVE: To investigate the effect of copper impregnated sanitary towels on the infection rate following vaginal delivery (VD). DESIGN: Single center double blind randomized controlled trial. PARTICIPANTS: Women aged 18 or over who had a sutured second-degree tear or episiotomy following VD. INTERVENTIONS: All women were randomized to receive either a copper-oxide impregnated sanitary towel (study group) or a non-copper sanitary towel (control group). MAIN OUTCOME MEASURES: The primary study outcome was the incidence of wound infection within a 30-day period from VD, assessed via telephone questionnaire. Secondary outcomes were length of hospital stay and risk factors of infection. RESULTS: 450 women were enrolled in the study of whom 225 were randomized to the copper impregnated sanitary towel (study group) and 225 to the non-copper sanitary towel (control group) group. Follow-up rate was 98.2%. A total of 102 women (23.1%) developed an infection within 30 days following VD, 19 in the study group (8.6%) and 83 (37.4%) in the control group (P = <0.001, absolute risk reduction (ARR) of 28.8%). The incidence of superficial/deep and organ/space infections was significantly lower in the study group (7.7% vs. 30.2%, P = <0.001 and 4.6% vs. 31.5%, P = <0.001 respectively) with an ARR of 22.5% and 27.0% respectively. Multivariable analysis reported Asian ethnicity and prolonged rupture of membranes as significant risk factors; for the development of infection (OR 1.91, P = 0.03 and OR = 1.97, P = 0.04 respectively). CONCLUSIONS: This is the first study to demonstrate a significant reduction in infection rate following VD with the use of copper impregnated sanitary towels.