Peceleganan Spray for the Treatment of Skin Wound Infections: A Randomized Clinical Trial.

Importance: Peceleganan spray is a novel topical antimicrobial agent targeted for the treatment of skin wound infections. However, its efficacy and safety remain unclear. Objective: To assess the safety and efficacy of peceleganan spray for the treatment of wound infections. Design, Setting, and Participants: This multicenter, open-label, phase 3 randomized clinical trial recruited and followed up 570 adult patients diagnosed with secondary open wound infections from 37 hospitals in China from August 23, 2021, to July 16, 2022. Interventions: Patients were randomized to 2 groups with a 2:1 allocation. One group received treatment with 2% peceleganan spray (n = 381) and the other with 1% silver sulfadiazine (SSD) cream (n = 189). Main Outcomes and Measures: The primary efficacy outcome was the clinical efficacy rate (the number of patients fulfilling the criteria for efficacy of the number of patients receiving the treatment) on the first day following the end of treatment (day 8). The secondary outcomes included the clinical efficacy rate on day 5 and the bacterial clearance rate (cases achieving negative bacteria cultures after treatment of all cases with positive bacteria cultures before treatment) on days 5 and 8. The safety outcomes included patients' vital signs, physical examination results, electrocardiographic findings, blood test results, and adverse reactions. Results: Among the 570 patients randomized to 1 of the 2 groups, 375 (98.4%) in the 2% peceleganan treatment group and 183 (96.8%) in the 1% SSD control group completed the trial (n = 558). Of these, 361 (64.7%) were men, and the mean (SD) age was 48.6 (15.3) years. The demographic characteristics were similar between groups. On day 8, clinical efficacy was achieved by 339 patients (90.4%) in the treatment group and 144 (78.7%) in the control group (P < .001). On day 5, clinical efficacy was achieved by 222 patients (59.2%) in the treatment group and 90 (49.2%) in the control group (P = .03). On day 8, bacterial clearance was achieved by 80 of 334 patients (24.0%) in the treatment group and in 75 of 163 (46.0%) in the control group (P < .001). On day 5, bacterial clearance was achieved by 55 of 334 patients (16.5%) in the treatment group and 50 of 163 (30.7%) in the control group (P < .001). The adverse events related to the application of peceleganan spray and SSD cream were similar. Conclusions and Relevance: This randomized clinical trial found that peceleganan spray is a safe topical antimicrobial agent with a satisfactory clinical efficacy rate for the treatment of skin wound infections, while the effectiveness of bacterial clearance remains uncertain. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR2100047202.

Clinical use of 0.1% polyhexanide and propylbetaine on acute and hard-to-heal wounds: a literature review.

OBJECTIVE: To summarise the findings on the effect of the clinical use of 0.1% polyhexanide-propylbetaine (PHMB/betaine) solution/gel on acute and hard-to-heal (chronic) wound healing. METHOD: A literature search was conducted in MEDLINE, CINAHL, Embase, Scopus and the CENTRAL Trials Registry of the Cochrane Collaboration. Paired reviewers conducted title and abstract screening and full-text screening to identify experimental, quasi-experimental and observational studies. Study quality and risk of bias were not formally evaluated. RESULTS: A total of 17 studies met the eligibility criteria. The findings from 12 studies indicated that the use of 0.1% PHMB/betaine solution/gel had: a low risk of contact sensitivity; could help debridement during wound cleansing; aided effective wound bed preparation; reduced wound size, odour and exudate; improved pain control; reduced microbial load; and enhanced wound healing. The results of three studies indicated that both 0.1% PHMB and saline solution were effective in reducing bacterial load, while another showed that adding 0.1% PHMB to tie-over dressings had no effect on reducing bacterial loads in wounds. Another study concluded that disinfection and granulation of pressure ulcers with hydrobalance dressing with 0.3% PHMB was faster and more effective than using 0.1% PHMB/betaine. CONCLUSION: The findings of this literature review showed that 0.1% PHMB/betaine solution/gel appeared to be useful and safe for wound cleansing, was effective in removing soft debris and slough from the wound bed, and created a wound environment optimal for healing. Although these actions cannot be attributed solely to this treatment modality, these results do highlight the unique action of this combined product. However, more robust studies are needed to confirm these results.

Amnion as an Innovative Antiseptic Carrier: A Comparison of the Efficacy of Allogeneic and Xenogeneic Transplantations in the Context of Burn Therapy.

Background and Objectives: The amniotic membrane is widely used in the treatment of chronic wounds, in toxic epidermal necrolysis (TEN), and in the treatment of burns. In our clinical practice, we use amniotic dressings on shallow skin wounds caused by burns. Counteracting infections is an important aspect of working with burn wounds. Therefore, the main goals of this work are to demonstrate the usefulness of amniotic membrane soaked in antiseptics for the prevention of wound infections and to compare the antibacterial efficacy of selected variants of allogeneic and xenogeneic amniotic membrane grafts soaked in specific antiseptic agents. Materials and Methods: The studied material consisted of human and pig placenta. The human and animal amnions were divided in two parts. The first part consisted of amniotic discs placed on rigid mesh discs and preparing the fresh amnion. The second part of the amnion was frozen at a temperature of -80 °C for 24 h. Then, it was radio-sterilized with a dose of 35 kGy. The amniotic discs were placed on rigid mesh to prepare the radiation-sterilized amnion. The amniotic discs were placed in a 12-well plate and immersed in 3 mL of the appropriate antiseptic solutions: Prontosan, Braunol, Borasol, Microdacyn, Octenilin, Sutrisept, and NaCl as a control. The amniotic discs were incubated in antiseptics for 3 h. The microbiological tests were conducted by placing the antiseptic-infused amniotic discs on microbiological media inoculated with hospital strains. Results: The largest average zone of growth inhibition was observed in dressings soaked with Sutrisept, Braunol, and Prontosan. The greatest inhibition of bacterial growth was achieved for radiation-sterilized porcine amnion impregnated with Braunol and Sutrisept, as well as for radiation-sterilized human amnion impregnated with Braunol. Conclusions: Human and porcine amniotic membrane is effective in carrying antiseptics. Radiation-sterilized amnion seems to inhibit the growth of microorganisms better than fresh amnion.

Comparison of the effect of licorice and chlorhexidine mouthwash on the oral health of intubated patients in the intensive care unit.

BACKGROUND: Chlorhexidine mouthwash is a common oral hygiene product used in intensive care units, but it may have some adverse effects. Licorice, a natural herb, could be a potential alternative to chlorhexidine. However, the effect of licorice mouthwash on the oral health of intubated patients has not been studied yet. Therefore, this study aimed to compare the effects of licorice and chlorhexidine mouthwash on the oral health of intubated patients. METHODS: This was a triple-blind clinical trial. The sample included 130 intubated patients admitted to an intensive care unit in Iran. The samples were selected by convenience sampling and randomly assigned to two groups: A and B. In group A, the main researcher applied 15 ml of 0.2% chlorhexidine mouthwash after each brushing (twice a day for 5.5 days) and suctioned it after 30 s. In group B, 20% licorice mouthwash was used instead of chlorhexidine. The demographic information questionnaire and the Beck Oral Assessment Scale (BOAS) were completed by one of the nurses before and on the sixth day of the study. RESULTS: Finally, 60 patients in each group completed the study. There was no significant difference between the groups in terms of demographic variables or oral health before the intervention (P > 0.05). The oral health of patients in both the chlorhexidine and liquorice mouthwash groups improved significantly after the intervention (P < 0.05). However, there was no significant difference in oral health between the two groups at postintervention (P = 0.06). CONCLUSION: The results demonstrated that both mouthwashes exerted a comparable effect on dental and oral health. However, the chlorhexidine mouthwash showed a greater impact on the reduction of dental plaque and the thinning of saliva compared to licorice mouthwash. In essential cases, licorice mouthwash can be employed as an alternative to chlorhexidine.

Early periodontal wound healing after chlorhexidine rinsing: a randomized clinical trial.

OBJECTIVES: This single-center randomized, parallel design, clinical trial with a 2-week follow-up involved patients affected by periodontitis undergoing periodontal surgery. The aim was to evaluate periodontal surgical wound healing with the use of chlorhexidine-based mouth rinses versus an untreated control group. MATERIALS AND METHODS: Periodontal surgery was performed following a standardized protocol. Patients were randomly prescribed i) chlorhexidine (CHX) + anti-discoloration system (ADS) + hyaluronic acid (HA), ii) CHX + ADS or iii) no treatment (control group). Plaque score, gingival inflammation, and Early Healing Index (EHI), assessing the degree of wound closure and the presence of fibrin and necrosis, were evaluated at 3, 7 and 14 days after surgery. RESULTS: In total, 33 patients were enrolled. Patients were comparable at baseline for all measured clinical parameters. At 3-days wound healing was significantly improved in all patients treated with CHX + ADS-based mouth rinses with a lower EHI score at the interdental papillae compared with control group (p < 0.01). CHX + ADS + HA group presented improved healing across all time points in terms of EHI, plaque containment, and gingival inflammation when compared to control group (p < 0.01). CONCLUSIONS: The usage of CHX-ADS following periodontal surgery improved early wound healing, reduced plaque accumulation and gingival inflammation. During the early post-operative period the adjunct of HA further improved soft tissue closure. CLINICAL RELEVANCE: This study aims at evaluating the response of gingival tissues to mouth rinsing with chlorhexidine and anti-discoloration system (CHX + ADS) or CHX + ADS + hyaluronic acid (CHX + ADS + HA) versus no rinse in terms of healing of the periodontal surgical wound. CHX + ADS mouth rinses enhanced early soft tissue closure after periodontal surgery and contributed to the reduction in plaque accumulation and gingival inflammation. The adjunct of HA may be beneficial especially in the early post-operative period. CHX + ADS administration following periodontal surgery may improve soft tissue healing in the first two post-operative weeks.

Comparing collagenase and silver sulfadiazine in deep second-degree burn treatment.

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.

A Review of Chlorhexidine Oral Care in Patients Receiving Mechanical Ventilation.

BACKGROUND: Chlorhexidine gluconate has been considered the criterion standard of oral care for patients receiving mechanical ventilation because of its ability to reduce the incidence of ventilator-associated events. Optimal concentrations and frequencies remain unclear, as do adverse events related to mortality in various intensive care unit populations. OBJECTIVE: To examine the current evidence for the efficacy of chlorhexidine gluconate in reducing the incidence of ventilator-associated events, mortality, intensive care unit length of stay, and duration of mechanical ventilation in patients receiving ventilator support. METHODS: In this integrative review, CINAHL (Cumulative Index to Nursing and Allied Health Literature), MEDLINE, and Health Source: Nursing/Academic Edition were searched using terms related to mechanical ventilation and chlorhexidine gluconate oral care with dates ranging from 2012 to 2023. RESULTS: Seventeen articles were included in this review: 8 systematic reviews, 8 randomized clinical trials (3 of which were not included in any systematic review), and 1 quasi-experimental study. Chlorhexidine gluconate oral care was associated with a reduced incidence of ventilator-associated events, but efficacy depended on concentration and frequency of administration. With stratification by intensive care unit population type, a nonsignificant trend toward increased mortality was found among non-cardiac surgical patients who received this care. CONCLUSION: The evidence regarding the efficacy of chlorhexidine gluconate oral care in reducing ventilator-associated events in specific intensive care unit populations is contradictory. Recently published guidelines recommend de-implementation of chlorhexidine gluconate oral care in all patients receiving mechanical ventilation. Such care may be beneficial only in the cardiac surgical population.

Satisfaction with government recommended pre-procedural mouth rinses in the mitigation of Covid-19 in Hong Kong SAR: A triple blind randomized controlled clinical trial.

OBJECTIVE: To evaluate satisfaction and acceptability with three pre-procedural mouthrinses recommended by the Government of Hong Kong Special Administrative Region (HKSAR) during the COVID-19 pandemic. MATERIAL AND METHODS: A triple-blind parallel-arm randomised controlled clinical trial was conducted. Following eligibility assessment, participants were block-randomised to the three intervention pre-procedural mouthrinses groups: Povidone-iodine, Hydrogen Peroxide and Chlorhexidine Digluconate. Participants rinsed with one of the mouthrinses assigned prior to any dental treatment. Participants, operators and assessors were blind to the assigned mouthrinses (triple blind). Satisfaction ratings were assessed on a 10 cm visual analogue scale (VAS) and acceptability of the mouthrinses were determined. RESULTS: Following clinical screening, 228 participants were involved in the trial. The mean overall VAS satisfaction was 7.35 (SD 1.68). There was no significant difference in VAS satisfaction ratings among the three groups (p>0.05) nor in between groups. Acceptability of the mouthrinses was high with the vast majority (89.5 %, 204) willing to use the mouthrinses again if pre-procedural mouthrinsing is required. There was no significant difference in acceptability ratings (p>0.05). There were some aspects such as taste and smell that participants commented on (on average, 24.6 %, 56), although no significant difference in prevalence of reports among groups (p>0.05). CONCLUSIONS: There were high rates of satisfaction and acceptability of the HKSAR Government recommended pre-procedural mouthrinses for the mitigation of COVID-19 transmission in the dental setting. There was no significant difference in satisfaction and acceptability rates among the three recommended pre-procedural mouthrinses. CLINICAL RELEVANCE: The high satisfaction and acceptability rates of the HKSAR Government recommended pre-procedural mouthrinses in the mitigation of COVID-19 in this clinical trial lends support for the HKSAR's policy on pre-procedural mouthrinses in the dental setting and this has implications for practice and policy during pandemics.

Quantitative analysis of the effects of brushing, flossing, and mouthrinsing on supragingival and subgingival plaque microbiota: 12-week clinical trial.

BACKGROUND: Translational microbiome research using next-generation DNA sequencing is challenging due to the semi-qualitative nature of relative abundance data. A novel method for quantitative analysis was applied in this 12-week clinical trial to understand the mechanical vs. chemotherapeutic actions of brushing, flossing, and mouthrinsing against the supragingival dental plaque microbiome. Enumeration of viable bacteria using vPCR was also applied on supragingival plaque for validation and on subgingival plaque to evaluate interventional effects below the gingival margin. METHODS: Subjects with gingivitis were enrolled in a single center, examiner-blind, virtually supervised, parallel group controlled clinical trial. Subjects with gingivitis were randomized into brushing only (B); brushing and flossing (BF); brushing and rinsing with Listerine® Cool Mint® Antiseptic (BA); brushing and rinsing with Listerine® Cool Mint® Zero (BZ); or brushing, flossing, and rinsing with Listerine® Cool Mint® Zero (BFZ). All subjects brushed twice daily for 1 min with a sodium monofluorophosphate toothpaste and a soft-bristled toothbrush. Subjects who flossed used unflavored waxed dental floss once daily. Subjects assigned to mouthrinses rinsed twice daily. Plaque specimens were collected at the baseline visit and after 4 and 12 weeks of intervention. Bacterial cell number quantification was achieved by adding reference amounts of DNA controls to plaque samples prior to DNA extraction, followed by shallow shotgun metagenome sequencing. RESULTS: 286 subjects completed the trial. The metagenomic data for supragingival plaque showed significant reductions in Shannon-Weaver diversity, species richness, and total and categorical bacterial abundances (commensal, gingivitis, and malodor) after 4 and 12 weeks for the BA, BZ, and BFZ groups compared to the B group, while no significant differences were observed between the B and BF groups. Supragingival plaque vPCR further validated these results, and subgingival plaque vPCR demonstrated significant efficacy for the BFZ intervention only. CONCLUSIONS: This publication reports on a successful application of a quantitative method of microbiome analysis in a clinical trial demonstrating the sustained and superior efficacy of essential oil mouthrinses at controlling dental plaque compared to mechanical methods. The quantitative microbiological data in this trial also reinforce the safety and mechanism of action of EO mouthrinses against plaque microbial ecology and highlights the importance of elevating EO mouthrinsing as an integral part of an oral hygiene regimen. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov on 31/10/2022. The registration number is NCT05600231.

Quantitative analysis of the effects of essential oil mouthrinses on clinical plaque microbiome: a parallel-group, randomized trial.

BACKGROUND: The rich diversity of microorganisms in the oral cavity plays an important role in the maintenance of oral health and development of detrimental oral health conditions. Beyond commonly used qualitative microbiome metrics, such as relative proportions or diversity, both the species-level identification and quantification of bacteria are key to understanding clinical disease associations. This study reports the first-time application of an absolute quantitative microbiome analysis using spiked DNA standards and shotgun metagenome sequencing to assess the efficacy and safety of product intervention on dental plaque microbiome. METHODS: In this parallel-group, randomized clinical trial, essential oil mouthrinses, including LISTERINE® Cool Mint Antiseptic (LCM), an alcohol-containing prototype mouthrinse (ACPM), and an alcohol-free prototype mouthrinse (AFPM), were compared against a hydroalcohol control rinse on clinical parameters and the oral microbiome of subjects with moderate gingivitis. To enable a sensitive and clinically meaningful measure of bacterial abundances, species were categorized according to their associations with oral conditions based on published literature and quantified using known amounts of spiked DNA standards. RESULTS: Multivariate analysis showed that both LCM and ACPM shifted the dysbiotic microbiome composition of subjects with gingivitis to a healthier state after 4 weeks of twice-daily use, resembling the composition of subjects with clinically healthy oral conditions recruited for observational reference comparison at baseline. The essential oil-containing mouthrinses evaluated in this study showed statistically significant reductions in clinical gingivitis and plaque measurements when compared to the hydroalcohol control rinse after 6 weeks of use. CONCLUSIONS: By establishing a novel quantitative method for microbiome analysis, this study sheds light on the mechanisms of LCM mouthrinse efficacy on oral microbial ecology, demonstrating that repeated usage non-selectively resets a gingivitis-like oral microbiome toward that of a healthy oral cavity. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov on 10/06/2021. The registration number is NCT04921371.

Wound healing effect of nutmeg (Myristica fragrans) cream on second-degree burn in animal model.

Second-degree burn, the most common among burn degrees, underscores the importance of timely and proper treatment in influencing prognosis. Nutmeg (Myristica fragrans), renowned for its potent antibacterial and antifungal properties, also serves as an effective antiseptic for open wounds. The aim of this study was to identify the phytochemical constituents of nutmeg essential oil and analyze the wound healing effect of nutmeg cream on second-degree burns in an animal model. An experimental study with a completed randomized design was conducted on Rattus norvegicus strain Wistar rats with second-degree burn. This study had four groups and each group consisting of four rats: B (burn-treated base cream), B+N (burn-treated 3% nutmeg cream), B+SSD (burn-treated silver sulfadiazine (BSS)), and B+N+SSD (burn-treated 3% nutmeg cream and SSD in a 1:1 ratio). The phytochemical analysis of nutmeg essential oil was conducted by gas chromatography and mass spectroscopy (GC-MS). The burn diameter and burn wound healing percentage were measured from day 0 to 18. One-way ANOVA followed by post hoc analysis using the least significant difference (LSD) was employed to analysis the effect. The phytochemical analysis of nutmeg essential oil found that myristicin, terpinene-4-ol, terpinene, safrole and terpinolene were the most abundant putative compounds in nutmeg essential oil. On day 0, the average burn wound diameters were 1.4 cm in all groups and increases were observed in all groups on day 3. The wound diameter decreased until day 18 with the smallest burn wound diameter was found in the B+N group (0.86±0.37 cm), followed by B+SSD (0.93±0.29 cm). The B+SSD group exhibited the highest percentage of burn wound healing (56.80±14.05%), which was significantly different from the base cream (p<0.05). The percentage of burn wound healing in rats given 3% nutmeg cream was 41.88±13.81%, suggesting that nutmeg cream could promote burn wound healing in rats induced by second-degree burns.

Comparison of hydro-fiber silver dressing and 1% silver sulfadiazine dressing for treatment of pediatric burns.

Burn is a debilitating and devastating emergency with many physical and psychological sequelae. Essential steps in burn wound management include cleansing/wound debridement, application of topical antimicrobial and dressing of affected body areas. Objective of this study is comparison in effectiveness of Hydro-fiber Silver dressing and 1% silver sulfadiazine dressing in management of pediatric burn patients in terms of wound healing. After ethical approval, 264 patients were enrolled and divided into two groups. Patients were managed with hydro-fiber silver dressing in group A and 1% silver sulfadiazine dressing in group B. An experienced pediatric surgeon examined the wounds for re epithelialization and efficacy was labeled after 15 days. Out of 264 enrolled patients 148(56.06%) were males and 116(43.94%) were females. Mean age of patients was 3.73±2.34 years. Type of burn was Scald in 215(81.4%) patients and flame in 49(18.6%). Depth of burn was 2nd degree in 185(70.08%) patients and 3rd degree in 79(29.92%) patients. Mean TBSA was 19.93±9.62%. In group A the efficacy was achieved in 91(68.9%) patients whereas in group B the efficacy was achieved in 73(55.3%) patients (p-value<0.05). Hydro-fiber Silver dressing is significantly more efficacious as compared to 1% silver sulfadiazine dressing for treatment of pediatric burn.

Quality of life case series review: wound bed preparation from a UK perspective.

Previous studies have reported that polyhexamethylene biguanide (PHMB) and betaine solution and gels remove biofilm, improve wound healing and reduce infection rates. Quality of life (QoL) outcomes are not commonly reported on when it comes to wound care. This review aims to summarise QoL data from a cohort of case studies previously published on chronic lower limb ulcers using PHMB products (Prontosan® Solution, Prontosan® Wound Gel X and Prontosan® Debridement Pad). Here, we report on and review a total of 38 case studies describing 56 wounds. From these 38 case studies, 36 reported that all the wounds involved had either healed or improved by the end of their respective study period. QoL themes explore malodour, slough, and exudate, pain, mobility, hair growth, antibiotic intake, return to work, social life and mood. This case series demonstrates that treatment with Prontosan® products improves many QoL outcomes for patients with non-healing wounds.

Effect of propolis mouthwash on the incidence of ventilator-associated pneumonia in intensive care unit patients: a comparative randomized triple-blind clinical trial.

OBJECTIVES: Ventilator-associated pneumonia (VAP) increases the length of hospitalization and mortality rate. This study aimed to determine the effect of propolis mouthwash on the incidence of VAP in intensive care unit (ICU) patients. MATERIALS AND METHODS: Triple-blind, comparative randomized, controlled clinical trial was conducted over one year, with 110 ICU patients at Imam-Hossein and Bahar hospitals (Shahroud) and Kowsar Hospital (Semnan) in Iran. The intervention group used 15 cc of 0.06% propolis mouthwash solution twice daily at 8 AM and 4 PM for seven days. The control group used 15 cc of 0.2% chlorhexidine mouthwash at the same times and duration. Data were collected using a demographic questionnaire, APACHE II, Beck Oral Assessment Scale, and Modified Clinical Pulmonary Infection Score (MCPIS). RESULTS: There was no significant difference in demographic information, disease severity, and oral health between the two groups before and after intervention (P > 0.05). The incidence of VAP in the intervention group compared to the control group was 10.9% vs. 30.9% on the third day (P = 0.0166, 95% CI: 0.53-0.83 and RR = 0.35), 23.6% vs. 43.6% on the fifth day (P = 0.0325 and 95% CI: 0.31-0.95 and RR = 0.54), and 25.5% vs. 47.3% on the seventh day (P = 0.0224, 95% CI: 0.32-0.92, and RR = 0.54). The Mann-Whitney indicated the incidence of VAP was significantly lower in the intervention group on the third, fifth, and seventh days. CONCLUSION: Propolis mouthwash can be considered as an alternative to chlorhexidine mouthwash for ICU patients. CLINICAL RELEVANCE: Propolis mouthwash serves as a simple, economical intervention to potentially reduce incidence of VAP. TRIAL REGISTRATION: (IRCT20110427006318N12, date 02.04.2019).

Safety and Efficacy of Ethanol for Catheter Salvage and Central Line-Associated Bloodstream Infection Prophylaxis in Polyurethane Catheters in the PICU.

OBJECTIVES: Ethanol lock therapy (ELT) is a potential method of central catheter salvage following central line-associated bloodstream infection (CLABSI) although there is potential risk of catheter damage in polyurethane catheters. Further, there is limited efficacy data across the spectrum of common pediatric catheters, and published ELT protocols describe dwell times that are not feasible for critically ill children. We sought to evaluate the safety and efficacy of ELT in polyurethane catheters using brief (30 min to 2 hr) dwell times in our PICU. DESIGN: Investigational pilot study using historical control data. SETTING: PICU in quaternary care, free-standing children's hospital. INTERVENTIONS: ELT in polyurethane central venous catheters for catheter salvage. RESULTS: ELT with brief dwell times was used in 25 patients, 22 of whom were bacteremic. Ultimately 11 patients, comprising 14 catheters, were diagnosed with a primary CLABSI. The catheter salvage rate in primary CLABSI patients receiving ELT was 92% (13/14) and significantly higher than the salvage rate in patients receiving antibiotics alone (non-ELT) (62%, 39/64; mean difference 0.32, 95% CI [0.14-0.50], p = 0.03). The rate of catheter fracture in all patients receiving ELT was 8% (2/25) while the rate of fracture in the non-ELT group was 13% (8/64; mean difference -0.05, 95% CI [-0.18 to 0.09], p = 0.72). The rate of tissue plasminogen activator (tPA) use in the ELT group was 8% (2/25), whereas the rate of tPA use in the non-ELT group was significantly higher at 42% (26/64; mean difference -0.34, 95% CI [-0.49 to -0.17], p = 0.002). CONCLUSIONS: The use of ELT for catheter salvage and prophylaxis in the PICU is safe in a variety of polyurethane catheters. Dwell times ranging from 30 minutes to 2 hours were effective in sterilizing the catheters while allowing other therapies to continue. This approach may decrease the need for frequent line changes in a medically fragile pediatric population.

Efficacy of sucrose and povidone-iodine mixtures in peritoneal dialysis catheter exit-site care.

BACKGROUND: Exit-site infection (ESI) is a common recurring complication in patients undergoing peritoneal dialysis (PD). Sucrose and povidone-iodine (SPI) mixtures, antimicrobial ointments that promote wound healing, have been used for the treatment of ulcers and burns, but their efficacy in exit-site care is still unclear. METHODS: This single-center retrospective observational study included patients who underwent PD between May 2010 and June 2022 and presented with episodes of ESI. Patients were divided into SPI and non-SPI groups and followed up from initial ESI onset until PD cessation, death, transfer to another facility, or June 2023. RESULTS: Among the 82 patients (mean age 62, [54-72] years), 23 were treated with SPI. The median follow-up duration was 39 months (range, 14-64), with an overall ESI incidence of 0.70 episodes per patient-year. Additionally, 43.1% of second and 25.6% of third ESI were caused by the same pathogen as the first. The log-rank test demonstrated significantly better second and third ESI-free survival in the SPI group than that in the non-SPI group (p < 0.01 and p < 0.01, respectively). In a Cox regression analysis, adjusting for potential confounders, SPI use was a significant predictor of decreased second and third ESI episodes (hazard ratio [HR], 0.22; 95% confidence interval [CI], 0.10-0.52 and HR, 0.22; 95%CI, 0.07-0.73, respectively). CONCLUSIONS: Our results showed that the use of SPI may be a promising option for preventing the incidence of ESI in patients with PD. TRIAL REGISTRATION: This study was approved by the Keio University School of Medicine Ethics Committee (approval number 20231078) on August 28, 2023. Retrospectively registered.

Assessment between antiseptic and normal saline for negative pressure wound therapy with instillation and dwell time in diabetic foot infections.

Negative pressure wound therapy with instillation and dwell time (NPWTi-d) is increasingly used for a diverse range of wounds. Meanwhile, the topical wound irrigation solution consisting of polyhexamethylene biguanide and betaine (PHMB-B) has shown efficacy in managing wound infections. However, the effectiveness of this solution as a topical instillation solution for NPWTi-d in patients with diabetic foot infections (DFIs) has not been thoroughly studied. The objective of this retrospective study was to evaluate the impact of using PHMB-B as the instillation solution during NPWTi-d on reducing bioburden and improving clinical outcomes in patients with DFIs. Between January 2017 and December 2022, a series of patients with DFIs received treatment with NPWTi-d, using either PHMB-B or normal saline as the instillation solution. Data collected retrospectively included demographic information, baseline wound characteristics, and treatment outcomes. The study included 61 patients in the PHMB-B group and 73 patients in the normal saline group, all diagnosed with DFIs. In comparison to patients treated with normal saline, patients with PHMB-B exhibited no significant differences in terms of wound bed preparation time (P = 0.5034), length of hospital stay (P = 0.6783), NPWTi-d application times (P = 0.1458), duration of systematic antimicrobial administration (P = 0.3567), or overall cost of hospitalization (P = 0.6713). The findings of the study suggest that the use of either PHMB-B or normal saline as an instillation solution in NPWTi-d for DFIs shows promise and effectiveness, yet no clinical distinction was observed between the two solutions.

A novel, reverse-phase-shifting, thermoreversible foaming hydrogel containing antibiotics for the treatment of thermal burns in a swine model - A pilot study.

BACKGROUND: This study compared a novel topical hydrogel burn dressing (CI-PRJ012) to standard of care (silver sulfadiazine) and to untreated control in a swine thermal burn model, to assess for wound healing properties both in the presence and absence of concomitant bacterial inoculation. METHODS: Eight equal burn wounds were created on six Yorkshire swine. Half the wounds were randomized to post-burn bacterial inoculation. Wounds were subsequently randomized to three treatments groups: no intervention, CI-PRJ012, or silver sulfadiazine cream. At study end, a blinded pathologist evaluated wounds for necrosis and bacterial colonization. RESULTS: When comparing CI-PRJ012 and silver sulfadiazine cream to no treatment, both agents significantly reduced the amount of necrosis and bacteria at 7 days after wound creation (p < 0.01, independently for both). Further, CI-PRJ012 was found to be significantly better than silver sulfadiazine (p < 0.02) in reducing bacterial colonization. For wound necrosis, no significant difference was found between silver sulfadiazine cream and CI-PRJ012 (p = 0.33). CONCLUSIONS: CI-PRJ012 decreases necrosis and bacterial colonization compared to no treatment in a swine model. CI-PRJ012 appeared to perform comparably to silver sulfadiazine. CI-PRJ012, which is easily removed with the application of room-temperature water, may provide clinical advantages over silver sulfadiazine.