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

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.

The impact of copper impregnated wound dressings on surgical site infection following caesarean section: a double blind randomised controlled study.

OBJECTIVE: To investigate the effect of copper impregnated wound dressings on the surgical site infection (SSI) rate following caesarean section (CS). DESIGN: Single centre double blind randomised controlled trial. PARTICIPANTS: Women aged 18 years or over who had a CS. INTERVENTIONS: All women were randomised to receive either a copper-oxide impregnated wound dressing (study group) or a non-copper wound dressing (control group). MAIN OUTCOME MEASURES: The primary study outcome was the incidence of SSI within a 30-day period from CS, assessed via a telephone questionnaire. Secondary outcomes were length of hospital stay, and readmission rate. RESULTS: 324 women were enrolled in the study of whom 159 were randomised to the study group and 165 to the control group. The follow up rate was 97.5%. A total of 78 women (24.1%) developed an SSI within 30 days following CS; 29 (18.2%) in the study group and 49 (29.7%) controls (P = 0.037, relative risk reduction (RRR) of 38.7%). The incidence of superficial/deep SSI was not significantly different (24.2% vs. 17.6%, P = 0.257), however a significant relative risk reduction of 80.3% for Organ/Space SSI was observed in the study group (12.7% vs. 2.5%, P = 0.002). Length of hospital stay, and readmission rate did not vary significantly between groups. CONCLUSIONS: This is the first study to demonstrate a significant reduction in SSI rates following CS with the use of copper impregnated wound dressings. The high SSI rate confirms the importance of new strategies to reduce the infection rate. Copper is a natural remedy which could potentially reduce hospital acquired infections without the use of antibiotics and its associated risks of antibiotic resistance.

Is endoanal, introital or transperineal ultrasound diagnosis of sphincter defects more strongly associated with anal incontinence?

INTRODUCTION AND HYPOTHESIS: Our aim was to explore the association between anal incontinence (AI) and persistent anal sphincter defects diagnosed with 3D endoanal (EAUS), introital (IUS) and transperineal ultrasound (TPUS) in women after obstetric anal sphincter injury (OASI) and study the association between sphincter defects and anal pressure. METHODS: We carried out a cross-sectional study of 250 women with OASI recruited during the period 2013-2015. They were examined 6-12 weeks postpartum or in a subsequent pregnancy with 3D EAUS, IUS and TPUS and measurement of anal pressure. Prevalence of urgency/solid/liquid AI or flatal AI and anal pressure were compared in women with a defect and those with an intact sphincter (diagnosed off-line) using Chi-squared and Mann-Whitney U test. RESULTS: At a mean of 23.6 (SD 30.1) months after OASI, more women with defect than those with intact sphincters on EAUS had AI; urgency/solid/liquid AI vs external defect: 36% vs 13% and flatal AI vs internal defect: 27% vs 13%, p < 0.05. On TPUS, more women with defect sphincters had flatal AI: 32% vs 13%, p = 0.03. No difference was found on IUS. Difference between defect and intact sphincters on EAUS, IUS and TPUS respectively was found for mean [SD] maximum anal resting pressure (48 [13] vs 55 [14] mmHg; 48 [12] vs 56 [13] mmHg; 50 [13] vs 54 [14] mmHg) and squeeze incremental pressure (33 [17] vs 49 [28] mmHg; 37 [23] vs 50 [28] mmHg; 36 [18] vs 50 [30] mmHg; p < 0.01). CONCLUSIONS: Endoanal ultrasound had the strongest association with AI symptoms 2 years after OASI. Sphincter defects detected using all ultrasound methods were associated with lower anal pressure.

The Use of Copper as an Antimicrobial Agent in Health Care, Including Obstetrics and Gynecology.

Health care-associated infections (HAIs) are a global problem associated with significant morbidity and mortality. Controlling the spread of antimicrobial-resistant bacteria is a major public health challenge, and antimicrobial resistance has become one of the most important global problems in current times. The antimicrobial effect of copper has been known for centuries, and ongoing research is being conducted on the use of copper-coated hard and soft surfaces for reduction of microbial contamination and, subsequently, reduction of HAIs. This review provides an overview of the historical and current evidence of the antimicrobial and wound-healing properties of copper and explores its possible utility in obstetrics and gynecology.

Comparing the diagnostic accuracy of 3 ultrasound modalities for diagnosing obstetric anal sphincter injuries.

BACKGROUND: The optimal imaging modality of obstetric anal sphincter injuries needs to take into consideration convenience, availability, and ability to assess the sphincter morphologic condition. Endoanal ultrasound imaging currently is regarded as the reference standard, but it is not widely available in obstetric units. Exoanal alternatives exist, such as 3-dimensional introital or transperineal ultrasound imaging, which are already readily available in most obstetrics and gynecology units. OBJECTIVE: The primary objective was to evaluate the diagnostic accuracy of 3-dimensional introital and 3-dimensional transperineal ultrasound imaging compared with 3-dimensional endoanal ultrasound imaging as the reference standard for the detection of anal sphincter defects in women who sustained obstetric anal sphincter injuries. The secondary objective was to correlate a diagnosis of anal sphincter defect on imaging to symptoms of anal incontinence, and to assess patient discomfort that is experienced for each imaging modality. STUDY DESIGN: A cross-sectional study was conducted of 250 women who sustained obstetric anal sphincter injuries, all of whom underwent 3-dimensional introital, transperineal, and endoanal ultrasound imaging. Introital and transperineal ultrasound imaging were assessed with tomographic ultrasound imaging. All of the women completed a validated modified St Mark's Score and Visual Analogue Score for discomfort. Optimal cut-off values for a significant defect on tomographic ultrasound imaging were defined as those with the greatest sensitivity and specificity based on receiver operating characteristic curves with endoanal ultrasound imaging as the reference standard. Diagnostic test characteristics of introital and transperineal ultrasound imaging were calculated with the use of these optimal cut-offs. RESULTS: Optimal cut-off for a significant external anal sphincter defect was ≥3 of 7 slices; sensitivity and specificity were 0.65 and 0.75 on introital imaging and 0.70 and 0.69 on transperineal ultrasound imaging. Optimal cut-off for a significant internal anal sphincter defect was ≥2 of 5 slices; sensitivity and specificity were 0.59 and 0.84 on introital imaging and 0.43 and 0.97 on transperineal ultrasound imaging. The area under the curve for the diagnosis of external and internal anal sphincter defects ranged from 0.70-0.74 (P<.001) for introital and transperineal imaging. Positive predictive value for external and internal sphincter defects ranged from 0.37-0.63, and negative predictive value ranged from 0.85-0.93 for introital and transperineal ultrasound imaging. Endoanal ultrasound imaging was the only modality for a defect to correlate with symptoms; mean modified St. Mark's score for a defect sphincter was 2.4 (standard deviation, 4.1) and for an intact sphincter was 0.9 (standard deviation, 2.7; P<.01). Introital and transperineal ultrasound imaging were associated with less discomfort than endoanal ultrasound imaging. CONCLUSION: Endoanal ultrasound imaging remains the most accurate diagnostic imaging modality. With low positive predictive values, introital and transperineal ultrasound imaging are not suitable for the identification of sphincter defects; however, high negative predictive values show a good ability to detect an intact sphincter. The optimal cut-off number of slices on tomographic ultrasound imaging for external and internal anal sphincters allows for standardization of a significant defect. In women with a history of obstetric anal sphincter injuries, introital and transperineal ultrasound imagings are suitable to screen for an intact sphincter if endoanal ultrasound imaging is not available. When defects are found, women should then have endoanal ultrasound imaging to verify the diagnosis.

Impact of copper compression stockings on venous insufficiency and lipodermatosclerosis: A randomised controlled trial.

OBJECTIVE: Compression stockings are the primary treatment for lipodermatosclerosis secondary to chronic venous disease, but do not improve the skin condition. The aim of this study was to investigate the impact of copper on lipodermatosclerosis. METHODS: A double-blind randomised controlled pilot study was performed including patients with bilateral lipodermatosclerosis. One compression stocking of a pair was impregnated with copper. Symptom score and surface area of lipodermatosclerosis were assessed at baseline, after 2, 4 and 8 weeks. RESULTS: Sixteen patients were included. There was no significant difference in mean symptom scores; however, there was a significant reduction of the surface area in the study group 42,637 to 35,739 mm2 versus 41,487 to 43,210 mm2 in the control group (p = 0.04). CONCLUSION: This study demonstrates the beneficial effect of copper on lipodermatosclerosis secondary to chronic venous disease with reduction in surface area but no benefit on symptoms. Trials identification number: NCT03283800.

Obstetric anal sphincter injury: a follow-up questionnaire study on longer-term outcomes.

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.