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Skin antisepsis with iodine povacrylex resulted in fewer surgical-site infections than antisepsis with chlorhexidine gluconate in patients with closed limb fractures but not in those with open fractures.

The Centre for the AIDS Program of Research in South Africa (CAPRISA) 004 trial assessed the effectiveness and safety of a 1% vaginal gel formulation of tenofovir, a nucleotide reverse transcriptase inhibitor, for the prevention of HIV acquisition in women. A double-blind, randomized controlled trial was conducted comparing tenofovir gel (n = 445 women) with placebo gel (n = 444 women) in sexually active, HIV-uninfected 18- to 40-year-old women in urban and rural KwaZulu-Natal, South Africa. HIV serostatus, safety, sexual behavior, and gel and condom use were assessed at monthly follow-up visits for 30 months. HIV incidence in the tenofovir gel arm was 5.6 per 100 women-years (person time of study observation) (38 out of 680.6 women-years) compared with 9.1 per 100 women-years (60 out of 660.7 women-years) in the placebo gel arm (incidence rate ratio = 0.61; P = 0.017). In high adherers (gel adherence > 80%), HIV incidence was 54% lower (P = 0.025) in the tenofovir gel arm. In intermediate adherers (gel adherence 50 to 80%) and low adherers (gel adherence < 50%), the HIV incidence reduction was 38 and 28%, respectively. Tenofovir gel reduced HIV acquisition by an estimated 39% overall, and by 54% in women with high gel adherence. No increase in the overall adverse event rates was observed. There were no changes in viral load and no tenofovir resistance in HIV seroconverters. Tenofovir gel could potentially fill an important HIV prevention gap, especially for women unable to successfully negotiate mutual monogamy or condom use.

In this single-center trial comparing chlorhexidine–alcohol with iodine–alcohol for skin antisepsis before cesarean delivery, the use of chlorhexidine–alcohol resulted in a risk of surgical-site infection that was significantly lower than that associated with iodine–alcohol. Cesarean delivery is the most common major surgical procedure among women in the United States. 1 In 2013, more than 32.7% (1.3 million) of the 3.9 million births were by cesarean section. 2 Surgical-site infections complicate 2 to 5% of all surgical procedures and 5 to 12% of cesarean deliveries. 3 – 6 Infection occurring after delivery places an extra burden on the new mother and may impair mother–infant bonding and breast-feeding. The average attributable hospital cost per surgical-site infection after cesarean delivery is estimated to be $3,529. 7 The skin is a major source of pathogens that cause surgical-site infections. Therefore, preoperative skin antisepsis . . .

The skin is a source of infection associated with surgery. In this multicenter, randomized trial, the preoperative application of chlorhexidine–alcohol was found to be a more effective skin preparation than povidone–iodine for preventing incisional infections. The preoperative application of chlorhexidine–alcohol was found to be a more effective skin preparation than povidone–iodine for preventing incisional infections. Despite the implementation of preoperative preventive measures, which include skin cleansing with povidone–iodine, surgical-site infection occurs in 300,000 to 500,000 patients who undergo surgery in the United States each year. 1 – 6 Since the patient's skin is a major source of pathogens, it is conceivable that improving skin antisepsis would decrease surgical-site infections. 7 The Centers for Disease Control and Prevention (CDC) recommends that 2% chlorhexidine-based preparations be used to cleanse the site of insertion of vascular catheters. 8 However, the CDC has not issued a recommendation as to which antiseptics should be used preoperatively to prevent postoperative surgical-site infection in the 27 . . .

New catheter materials for peripherally inserted central catheters (PICCs) may reduce the risk of device failure due to infectious, thrombotic, and catheter occlusion events. However, data from randomized trials comparing these catheters are lacking. We conducted a randomized, controlled, superiority trial in three Australian tertiary hospitals. Adults and children who were referred for PICC placement were assigned in a 1:1:1 ratio to receive a hydrophobic or chlorhexidine PICC or a standard polyurethane PICC and were followed for 8 weeks. The primary outcome was device failure, which was a composite of infectious (bloodstream or local) or noninfectious (thrombosis, breakage, or occlusion) complications. A total of 1098 participants underwent randomization; 365 were assigned to the hydrophobic group, 365 to the chlorhexidine group, and 368 to the standard-polyurethane group. Device failure occurred in 21 of 358 participants (5.9%) in the hydrophobic group, in 36 of 363 (9.9%) in the chlorhexidine group, and in 22 of 359 (6.1%) in the standard-polyurethane group (risk difference, hydrophobic vs. standard polyurethane, -0.2 percentage points [95% confidence interval {CI}, -3.7 to 3.2; P = 0.89]; and chlorhexidine vs. standard polyurethane, 3.8 percentage points [95% CI, -0.1 to 7.8; P = 0.06]). In the hydrophobic group as compared with the standard-polyurethane group, the odds ratio for device failure was 0.96 (95% CI, 0.51 to 1.78), and in the chlorhexidine group as compared with the standard-polyurethane group, the odds ratio was 1.71 (95% CI, 0.98 to 2.99). Complications from any cause during the period of PICC placement occurred in 77 participants (21.5%) in the hydrophobic group, in 140 (38.6%) in the chlorhexidine group, and in 78 (21.7%) in the standard-polyurethane group (odds ratio, hydrophobic vs. standard polyurethane, 0.99 [95% CI, 0.69 to 1.42]; and chlorhexidine vs. standard polyurethane, 2.35 [95% CI, 1.68 to 3.29]). No adverse events were attributable to the interventions. Among adults and children who were referred for PICC placement, the risk of device failure due to noninfectious or infectious complications was not lower with hydrophobic or chlorhexidine PICCs than with standard polyurethane PICCs. (Funded by the National Health and Medical Research Council of Australia; PICNIC Australian New Zealand Clinical Trials Registry number, ACTRN12619000022167.).

The CHARM-01 study characterized the safety, acceptability, pharmacokinetics (PK), and pharmacodynamics (PD) of three tenofovir (TFV) gels for rectal application. The vaginal formulation (VF) gel was previously used in the CAPRISA 004 and VOICE vaginal microbicide Phase 2B trials and the RMP-02/MTN-006 Phase 1 rectal safety study. The reduced glycerin VF (RGVF) gel was used in the MTN-007 Phase 1 rectal microbicide trial and is currently being evaluated in the MTN-017 Phase 2 rectal microbicide trial. A third rectal specific formulation (RF) gel was also evaluated in the CHARM-01 study. Participants received 4 mL of the three TFV gels in a blinded, crossover design: seven daily doses of RGVF, seven daily doses of RF, and six daily doses of placebo followed by one dose of VF, in a randomized sequence. Safety, acceptability, compartmental PK, and explant PD were monitored throughout the trial. All three gels were found to be safe and acceptable. RF and RGVF PK were not significantly different. Median mucosal mononuclear cell (MMC) TFV-DP trended toward higher values for RF compared to RGVF (1136 and 320 fmol/106 cells respectively). Use of each gel in vivo was associated with significant inhibition of ex vivo colorectal tissue HIV infection. There was also a significant negative correlation between the tissue levels of TFV, tissue TFV-DP, MMC TFV-DP, rectal fluid TFV, and explant HIV-1 infection. All three formulations were found to be safe and acceptable. However, the safety profile of the VF gel was only based on exposure to one dose whereas participants received seven doses of the RGVF and RF gels. There was a trend towards higher tissue MMC levels of TFV-DP associated with use of the RF gel. Use of all gels was associated with significant inhibition of ex vivo tissue HIV infection. ClinicalTrials.gov NCT01575405.

The indications for collagenase ointment (CO) and its efficacy are not clearly established in the treatment of second-degree burn wounds. To evaluate the efficacy of CO versus silver sulfadiazine ointment (SSD) in the treatment of second-degree burn wounds. A total of 170 eligible patients with deep second-degree burns, aged 18–65 years, with injuries occurring within 48–96 h, and having a total wound area of less than 30% of the total body surface area were included from 5 centers in China. The primary outcome was the wound healing time, and the secondary outcomes were the clearance time of wound necrotic tissues, wound healing rate, and wound inflammation. The study included 85 patients in SSD group and 84 in CO group in the modified intention-to-treat (mITT) population. The median time of wound healing was comparable in both groups (10 days vs. 10.5 days P  = 0.16). The time for wound necrotic tissue removal was significantly shortened by CO compared with SSD (5 vs. 10 days P  < 0.01). Wound inflammation, pain, wound healing rate, and scar were compared with SSD (all P-values > 0.05). No adverse events, such as infection or allergic reactions to the drugs and materials used, were reported. Both CO and SSD could heal the burn wounds at 10 days of treatment. However, CO significantly shortened the time of wound necrotic tissue removal by 5 days. Trial Registration: ChiCTR2100046971.

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)

Background To evaluate the antiplaque effects of an alcohol-free mouthrinse containing essential oils—Listerine Zero (LZ)—and an alcohol-based essential oils mouthrinse (EO+) compared with a positive control of 0.20% chlorhexidine mouthrinse (CHX) and a negative control of a placebo solution (saline), using an in vivo plaque regrowth model of three days. Methods The study was designed as a double-masked, randomized, crossover clinical trial, involving 21 volunteers to compare four different mouthrinses, using a three-day plaque regrowth model. After receiving thorough professional prophylaxis at baseline, over the next three days each volunteer refrained from all oral hygiene measures and performed two daily rinses with 15 mL of the test mouthrinses. EO+ was compared with LZ. CHX rinse served as a positive control and a placebo solution as a negative control. At the end of each experimental period, the Plaque Index (PI) was assessed and a panelist completed through a visual analogue scale (VAS) questionnaire evaluating the organoleptic properties of each product. Each participant underwent a 14-day washout period and then there was another allocation. Results LZ showed the same inhibitory activity on plaque regrowth compared with EO+ in the whole mouth (PI = 1.72 versus 1.65, respectively), but there was less of an effect compared to the CHX (overall PI of 1.07) and a more efficient activity than the saline solution negative control (PI = 2.31). The difference of 0.07 between LZ and EO+ was not statistically significant. Conclusions LZ seems to have the same inhibiting effect on plaque regrowth as EO+ and a less inhibiting effect than the CHX control. Both LZ and EO+, as well as the CHX control, show a better inhibiting effect on plaque regrowth than the placebo solution. Trial registration ClinicalTrials.gov, NCT02894593 . Registered on 4 September 2016.

Background The preoperative body surface and nasal decolonization may reduce the risk of surgical site infections (SSI) but yields conflicting results in the current orthopedic literature. Methods We perform a single-center, randomized-controlled, superiority trial in favor of the preoperative decolonization using a commercial product (octenidine® set). We will randomize a total number of 1000 adult elective orthopedic patients with a high risk for SSI and/or wound complications (age ≥ 80 years, chronic immune-suppression, American Society of Anesthesiologists score 3–4 points) between a decolonization (octenisan® wash lotion 1 × per day and octenisan® md nasal gel 2–3 × per day; during 5 days) and no decolonization. Decolonized patients will additionally fill a questionnaire regarding the practical difficulties, the completeness, and the adverse events of decolonization. The primary outcomes are SSI and revision surgeries for postoperative wound problems until 6 weeks postoperatively (or 1 year for surgeries with implants or bone). Secondary outcomes are unplanned revision surgeries for non-infectious problems and all adverse events. With 95% event-free surgeries in the decolonization arm versus 90% in the control arm, we formally need 2 × 474 elective orthopedic surgeries included during 2 years. Discussion In selected adult orthopedic patients with a high risk for SSI, the presurgical decolonization may reduce postoperative wound problems, including SSI. Trial registration ClinicalTrial.gov NCT05647252. Registered on 9 December 2022. Protocol version: 2 (5 December 2022).