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.
Subject(s)
Copper/pharmacology , Episiotomy/instrumentation , Menstrual Hygiene Products/standards , Perineum/surgery , Surgical Wound Infection/prevention & control , Adolescent , Adult , Anti-Infective Agents, Local/pharmacology , Anti-Infective Agents, Local/therapeutic use , Copper/therapeutic use , Double-Blind Method , Episiotomy/adverse effects , Episiotomy/methods , Female , Hospitals, University/organization & administration , Hospitals, University/statistics & numerical data , Humans , Menstrual Hygiene Products/statistics & numerical data , Perineum/abnormalities , Pregnancy , Surgical Wound Infection/drug therapyABSTRACT
INTRODUCTION AND HYPOTHESIS: Obstetric anal sphincter injuries (OASIS) contribute significantly to the development of anal incontinence (AI) in women. The aim of this study was to establish the incidence of AI after OASIS and to study the influence on the quality of life (QoL) in patients with OASIS. METHODS: This cohort study, with prospective case-control follow-up, involves women who were treated for OASIS between 2005 and 2012 in two academic medical centers in The Netherlands. Three hundred and thirteen patients and 780 controls were invited to complete a validated questionnaire (Defecation Distress Inventory, Wexner Incontinence Score, and Fecal Instrument Quality of Life) regarding symptoms and bother of AI subsequent and QoL after delivery. The main outcome measures were the presence of AI and the impact on QoL. RESULTS: The questionnaire was completed by 141 patients and 194 controls. Mean follow-up was 4 years (range 1-9 years) in both groups. In the patient group, 55 women (39 %) reported AI symptoms compared with 38 women (20 %) in the control group (odds ratio 2.7, 95 % confidence interval 1.66-4.47, p < 0.01). In women who experienced symptoms of AI as very bothersome, QoL was affected in 14 (82.0 %) patients and three (33.5 %) controls (p = 0.012). CONCLUSIONS: In this study, women with OASIS had a more than doubled risk of longer-term bothersome symptoms of AI compared with controls. Symptoms were experienced as bothersome and as having an influence on QoL.
