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

Abstract

To investigate the effect of copper impregnated sanitary towels on the infection rate following vaginal delivery (VD). Single center double blind randomized controlled trial. Women aged 18 or over who had a sutured second-degree tear or episiotomy following VD. All women were randomized to receive either a copper-oxide impregnated sanitary towel (study group) or a non-copper sanitary towel (control group). 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. 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). This is the first study to demonstrate a significant reduction in infection rate following VD with the use of copper impregnated sanitary towels.