ObjectiveTo evaluate whether 1% aqueous chlorhexidine gluconate (CHG) when compared with 2% aqueous chlorhexidine gluconate is non-inferior for neonatal skin antisepsis.DesignParallel, blinded, non-inferiority randomised trial.SettingLevel III, academic, neonatal intensive care unit.PatientsInfants born at 260/7 to 426/7 weeks of gestation from June 2019 to December 2019.InterventionsParticipants were randomised to skin antisepsis by either 1% aqueous CHG or 2% aqueous CHG.Main outcome measuresThe primary outcome was the proportion of negative skin swab cultures after skin antisepsis. Secondary outcomes were local skin reactions at 0, 6, 12 and 24 hours and plasma chlorhexidine levels in a subset of the study population.ResultsA total of 308 neonates with a median gestation age of 34 (31–37) weeks and mean birth weight of 2029 g were randomised on 685 occasions (1% CHG: n=341; 2% CHG: n=344). 93.0% of the post-antisepsis skin swabs were sterile in 1% CHG group compared with 95.6% of the swabs in the 2% CHG group (risk difference −2.7%, 95% CI −6.2% to +0.8%). The lower bound of 95% CI crossed the pre-specified absolute non-inferiority limit of 5%. Neonates developed mild dermatitis on 16 (2.3%) occasions. There was no significant difference in median plasma CHG levels in the two groups, 19.6 (12.5–36.4) and 12.6 (8.7–26.6) ng/mL, respectively.ConclusionsApplication of 1% aqueous CHG was not shown to be non-inferior to 2% chlorhexidine aqueous for skin antisepsis in neonates. There were no severe skin-related adverse events in either of the two groups.Trial registration numberCTRI/2019/06/019822; (http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=33453&EncHid=&userName=CTRI/2019/06/019822)
To compare the efficacy of calcium alginate dressings with betadine dressings in the management of non-malignant non-healing ulcers MATERIALS AND METHODS: The study was conducted on 60 patients with non-malignant non-healing ulcers in M.S. Ramaiah Medical Teaching Hospital between June 2 nd 2008 and July 31 st 2010. They were randomly divided into groups of 30. History was taken and relevant investigations done to rule out any focus of infection. All 60 patients were followed up for 6 months. Patients were assessed on many factors like size of ulcer, site, culture sensitivity of swab, co-morbidities. RESULT: There was similar improvement in both study groups with no complications in either. All parameters were comparable. CONCLUSION: Silver and calcium alginate wound dressings though more expensive have comparable efficacy compared to simple betadine dressings in the treatment of non-healing ulcers KEYWORDS: Chronic ulcers, silver calcium alginate INTRODUCTION: Chronic wounds, defined as wounds that fail to heal after three months, are an important cause of physical and emotional stress as well financial burden, especially in patients over the age of 60 years. It is major cause of morbidity in diabetics-around 700,000 amputations are performed annually in diabetics. In India, it is estimated that diabetic foot ulcers are responsible for 10% of hospital admissions and 40,000 legs are amputated annually due to diabetes. However studies show that with a multidisciplinary approach and an aggressive conservative management of diabetic foot ulcers, amputation can be avoided. Although many expensive solutions, ointments, granules and wound-care technologies are available, evidence suggests that none of these are more effective than meticulous wound care. Calcium alginate dressings have been in use for around 3 decades and have been used extensively
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