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5,997 result(s) for "Burns - therapy"
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Efficacy and tolerability of a cocktail of bacteriophages to treat burn wounds infected by Pseudomonas aeruginosa (PhagoBurn): a randomised, controlled, double-blind phase 1/2 trial
Wound infections are the main cause of sepsis in patients with burns and increase burn-related morbidity and mortality. Bacteriophages, natural bacterial viruses, are being considered as an alternative therapy to treat infections caused by multidrug-resistant bacteria. We aimed to compare the efficacy and tolerability of a cocktail of lytic anti-Pseudomonas aeruginosa bacteriophages with standard of care for patients with burns. In this randomised phase 1/2 trial, patients with a confirmed burn wound infection were recruited from nine burn centres in hospitals in France and Belgium. Patients were eligible if they were aged 18 years or older and had a burn wound clinically infected with P aeruginosa. Eligible participants were randomly assigned (1:1) by use of an interactive web response system to a cocktail of 12 natural lytic anti-P aeruginosa bacteriophages (PP1131; 1 × 106 plaque-forming units [PFU] per mL) or standard of care (1% sulfadiazine silver emulsion cream), both given as a daily topical treatment for 7 days, with 14 days of follow-up. Masking of treatment from clinicians was not possible because of the appearance of the two treatments (standard of care a thick cream, PP1131 a clear liquid applied via a dressing), but assignments were masked from microbiologists who analysed the samples and patients (treatment applied while patients were under general anaesthetic). The primary endpoint was median time to sustained reduction in bacterial burden by at least two quadrants via a four-quadrant method, assessed by use of daily swabs in all participants with a microbiologically documented infection at day 0 who were given at least one sulfadiazine silver or phage dressing (modified intention-to-treat population). Safety was assessed in all participants who received at least one dressing according to protocol. Ancillary studies were done in the per-protocol population (all PP1131 participants who completed 7 days of treatment) to assess the reasons for success or failure of phage therapy. This trial is registered with the European Clinical Trials database, number 2014-000714-65, and ClinicalTrials.gov, number NCT02116010, and is now closed. Between July 22, 2015, and Jan 2, 2017, across two recruitment periods spanning 13 months, 27 patients were recruited and randomly assigned to receive phage therapy (n=13) or standard of care (n=14). One patient in the standard of care group was not exposed to treatment, giving a safety population of 26 patients (PP1131 n=13, standard of care n=13), and one patient in the PP1131 group did not have an infection at day 0, giving an efficacy population of 25 patients (PP1131 n=12, standard of care n=13). The trial was stopped on Jan 2, 2017, because of the insufficient efficacy of PP1131. The primary endpoint was reached in a median of 144 h (95% CI 48–not reached) in the PP1131 group versus a median of 47 h (23–122) in the standard of care group (hazard ratio 0·29, 95% CI 0·10–0·79; p=0·018). In the PP1131 group, six (50%) of 12 analysable participants had a maximal bacterial burden versus two (15%) of 13 in the standard of care group. PP1131 titre decreased after manufacturing and participants were given a lower concentration of phages than expected (1 × 102 PFU/mL per daily dose). In the PP1131 group, three (23%) of 13 analysable participants had adverse events versus seven (54%) of 13 in the standard of care group. One participant in each group died after follow-up and the deaths were determined to not be related to treatment. The ancillary study showed that the bacteria isolated from patients with failed PP1131 treatment were resistant to low phage doses. At very low concentrations, PP1131 decreased bacterial burden in burn wounds at a slower pace than standard of care. Further studies using increased phage concentrations and phagograms in a larger sample of participants are warranted. European Commission: Framework Programme 7.
Burn Wound Healing: Clinical Complications, Medical Care, Treatment, and Dressing Types: The Current State of Knowledge for Clinical Practice
According to the World Health Organization (WHO), it is estimated that each year approximately 11 million people suffer from burn wounds, 180,000 of whom die because of such injuries. Regardless of the factors causing burns, these are complicated wounds that are difficult to heal and are associated with high mortality rates. Medical care of a burn patient requires a lot of commitment, experience, and multidirectional management, including surgical activities and widely understood pharmacological approaches. This paper aims to comprehensively review the current literature concerning burn wounds, including classification of burns, complications, medical care, and pharmacological treatment. We also overviewed the dressings (with an emphasis on the newest innovations in this field) that are currently used in medical practice to heal wounds.
A Randomized Trial of Enteral Glutamine for Treatment of Burn Injuries
Glutamine is thought to have beneficial effects on the metabolic and stress response to severe injury. Clinical trials involving patients with burns and other critically ill patients have shown conflicting results regarding the benefits and risks of glutamine supplementation. In a double-blind, randomized, placebo-controlled trial, we assigned patients with deep second- or third-degree burns (affecting ≥10% to ≥20% of total body-surface area, depending on age) within 72 hours after hospital admission to receive 0.5 g per kilogram of body weight per day of enterally delivered glutamine or placebo. Trial agents were given every 4 hours through a feeding tube or three or four times a day by mouth until 7 days after the last skin grafting procedure, discharge from the acute care unit, or 3 months after admission, whichever came first. The primary outcome was the time to discharge alive from the hospital, with data censored at 90 days. We calculated subdistribution hazard ratios for discharge alive, which took into account death as a competing risk. A total of 1209 patients with severe burns (mean burn size, 33% of total body-surface area) underwent randomization, and 1200 were included in the analysis (596 patients in the glutamine group and 604 in the placebo group). The median time to discharge alive from the hospital was 40 days (interquartile range, 24 to 87) in the glutamine group and 38 days (interquartile range, 22 to 75) in the placebo group (subdistribution hazard ratio for discharge alive, 0.91; 95% confidence interval [CI], 0.80 to 1.04; P = 0.17). Mortality at 6 months was 17.2% in the glutamine group and 16.2% in the placebo group (hazard ratio for death, 1.06; 95% CI, 0.80 to 1.41). No substantial between-group differences in serious adverse events were observed. In patients with severe burns, supplemental glutamine did not reduce the time to discharge alive from the hospital. (Funded by the U.S. Department of Defense and the Canadian Institutes of Health Research; RE-ENERGIZE ClinicalTrials.gov number, NCT00985205.).
Music therapy with adult burn patients in the intensive care unit: short-term analysis of electrophysiological signals during music-assisted relaxation
Burn patients often face elevated pain, anxiety, and depression levels. Music therapy adds to integrative care in burn patients, but research including electrophysiological measures is limited. This study reports electrophysiological signals analysis during Music-Assisted Relaxation (MAR) with burn patients in the Intensive Care Unit (ICU). This study is a sub-analysis of an ongoing trial of music therapy with burn patients in the ICU. Electroencephalogram (EEG), electrocardiogram (ECG), and electromyogram (EMG) were recorded during MAR with nine burn patients. Additionally, background pain levels (VAS) and anxiety and depression levels (HADS) were assessed. EEG oscillation power showed statistically significant changes in the delta ( p  < 0.05), theta ( p  = 0.01), beta ( p  < 0.05), and alpha ( p  = 0.05) bands during music therapy. Heart rate variability tachograms high-frequencies increased ( p  = 0.014), and low-frequencies decreased ( p  = 0.046). Facial EMG mean frequency decreased ( p  = 0.01). VAS and HADS scores decreased − 0.76 ( p  = 0.4) and − 3.375 points ( p  = 0.37) respectively. Our results indicate parasympathetic system activity, attention shifts, reduced muscle tone, and a relaxed state of mind during MAR. This hints at potential mechanisms of music therapy but needs to be confirmed in larger studies. Electrophysiological changes during music therapy highlight its clinical relevance as a complementary treatment for ICU burn patients. Trial registration : Clinicaltrials.gov (NCT04571255). Registered September 24th, 2020. https//classic.clinicaltrials.gov/ct2/show/NCT04571255.
Comparison of prognostic value of Roper Hall and Dua classification systems in acute ocular burns
AimTo compare the predictive outcome of ocular burns using two different prognostic classification systems, that is, Dua and Roper Hall classification.Patients and methodsIn a prospective, randomised, controlled clinical trial, the extent of acute ocular burns in 100 patients was graded by Roper Hall and Dua classifications. Patients were randomised in two groups of 50 each to receive conventional medical therapy alone or additional amniotic membrane transplantation (AMT). Moderate burns were graded similarly (grade II and III) under both systems, while severe burns were classified differently and compared further. Baseline parameters (size of epithelial defect, corneal haze, limbal ischaemia, conjunctival involvement and visual acuity) and outcome variables (healing of epithelial defect, corneal clarity, corneal vascularisation, visual outcome and symblepharon) after 1 year were noted and compared.ResultsThere was no difference in terms of time taken and rate of healing of epithelial defect, but there was a significant difference in extent of corneal vascularisation between grades IV, V and VI (p<0.05). In patients who received AMT in addition to medical therapy, the degree of corneal clarity achieved was significantly better in patients with grade IV burns than either grade V (p=0.045) or grade VI (p=0.024) burns, and final visual acuity was significantly better in these patients (p=0.043). On comparison of patients with grade IV burns (with and without AMT), the outcome in terms of extent of corneal vascularisation was significantly better (p=0.0124) in patients who received AMT.ConclusionsDua classification by providing further subclassification of grade IV ocular burns by Roper Hall into three separate grades has a superior prognostic predictive value in severe ocular burns.
Evaluation of the efficacy, safety, and satisfaction rate of topical latanoprost in patients with hypopigmented burn scars treated with fractional CO2 laser: a double-blind randomized controlled clinical trial
Burn scars present psychological and social challenges for patients, classified into atrophic and hypertrophic types. Treatments like corticosteroid injections, laser therapy, and platelet-rich plasma (PRP) injections are commonly recommended for hypertrophic scars, while regenerative medicine and fractional CO2 lasers are linked to some degree of improvement for atrophic scars. Hypopigmented and depigmented burn scars pose ongoing challenges for healthcare providers and patients, with therapies such as intense pulsed light and fractional CO2 laser showing variable effects in treating these conditions. This study evaluates the effectiveness of latanoprost, a prostaglandin analog, in combination with fractional CO2 laser for repigmentation of hypopigmented burn scar lesions. During the study, patients were treated with 0.005% latanoprost eye drop or normal saline twice a day for 6 months and underwent six monthly fractional CO2 laser sessions. Treatment instructions were provided by the physician, and patients were instructed to report any complications and avoid using other medications in the treatment area. Assessments included photography at the start of the study and in three follow-up sessions at three-month intervals. Improvement was assessed using the Subject Global Aesthetic Improvement Scale (SGAIS) by both the physician and patients. Patient satisfaction was evaluated using a Grade scale, and side effects were monitored in all follow-up sessions. In the third follow-up session, physicians assessing the Subject Global Aesthetic Improvement Scale (SGAIS) observed that a higher proportion (85.7%) of cases in the fractional CO2 laser with latanoprost group achieved a grade of 4 (50–74% improvement). In the placebo group, 0% of patients achieved grade 4, and 71.4% were classified as grade 2 (0–24% improvement), indicating a significant difference (P-value: 0.0001). Patient satisfaction, measured by the \"Grade scale to evaluate patient satisfaction\" index, revealed a notable contrast between the two groups, with average satisfaction scores of 8.50 ± 0.65 and 4.64 ± 1.00 for the fractional CO2 laser with latanoprost and placebo groups, respectively, indicating a statistically significant difference (P = 0.0001). Furthermore, throughout the study, no severe side effects were reported by any of the patients. Prostaglandin analogs, particularly latanoprost, have proven to be effective in promoting repigmentation of hypopigmented and depigmented burn scar lesions. When this topical medication is combined with fractional CO2 laser treatment, it enhances the laser's efficacy and overall effectiveness in treating the lesions. This combination is crucial for improving hypopigmented scar treatment by enhancing both the laser's effectiveness in scar improvement and the delivery of latanoprost through the laser. What is already known about this topic? Hypopigmented burn scars are one of the manifestations of burns that are resistant to treatment. These scars not only cause discomfort for patients but also present a treatment challenge for physicians. In previous studies, latanoprost and bimatoprost, analogs of prostaglandin PGF2a, showed effectiveness in repigmenting vitiligo lesions. However, no study has examined the role of these topical drugs in treating hypopigmented and depigmented burn scars. What does this study add? The fractional CO2 laser caused significant repigmentation in hypopigmented lesions of burn scars. 64.3% of the patients who received this intervention showed grade 2 improvement (0-24% improvement), 7.1% showed grade 3 improvement (25-49% improvement), and 28.6% showed no improvement (grade 1) in the third follow-up session based on the SGAIS criteria as evaluated by the patients. The combination of CO2 fractional laser and latanoprost caused significant repigmentation in hypopigmented burn scar lesions. 85.7% of patients showed grade 4 improvement (50-74% improvement), and 14.3% showed grade 3 improvement (25-49% improvement) and 0% showed no improvement (grade 1) in the third follow-up session based on the SGAIS criteria as evaluated by the patients. The combination of CO2 fractional laser and latanoprost was significantly more effective than CO2 fractional laser alone based on the SGAIS criteria, as evaluated by physicians and patients in all three follow-up sessions. Additionally, the satisfaction of the patients in the combined treatment group was significantly higher than that of the CO2 fractional laser treatment group.
Smartphone virtual reality for pain management during pediatric burn care transition: study protocol for a randomized controlled trial
Background Burn injuries severe enough to result in emergency department visits are a large burden for US children. Treatment for these injuries often involves daily dressing changes at home, which can be very painful and anxiety-inducing. This trial aims to evaluate the efficacy of a virtual reality therapeutic for pain and anxiety alleviation during repeated at-home burn dressing changes among pediatric patients. Methods Two hundred children with burn injuries requiring daily dressing changes will be recruited from two American Burn Association-verified burn centers in the USA for this randomized, controlled, two-arm clinical trial with a 1:1 allocation ratio. During each dressing change at home, the intervention group will play the Virtual Reality Pain Alleviation Therapeutic (VR-PAT) game and answer questions about their pain, anxiety state, pain medication usage, simulator sickness symptoms, and experience playing the game. The control group will perform their dressing as usual without the VR-PAT and answer questions about their pain, anxiety state, and pain medication usage. The primary outcome is the difference in self-reported pain and anxiety between the two groups over their week of dressing changes. Discussion The transition of burn injury treatment from the medical center to the home can increase anxiety for children and their parents. Virtual reality is a promising digital technology that can improve wound care for these children. Findings from this trial will provide data on the efficacy of the VR-PAT for reducing self-reported pain and anxiety during daily home dressing changes for pediatric burn care. The results from this trial will serve as evidence for a large-scale implementation study. Trial registration ClinicalTrials.gov NCT05673551. Registered on December 21, 2022.
Implementation of negative pressure for acute pediatric burns (INPREP): A stepped-wedge cluster randomized controlled trial protocol
Acute application of adjunctive negative pressure wound therapy (NPWT) significantly improves time to re-epithelialization in pediatric burn patients. This adjunctive treatment has not yet been broadly or routinely adopted as a standard primary burns dressing strategy. The Implementation of Negative PRessurE for acute Pediatric burns (INPREP) trial will implement and evaluate the impact of adjunctive NPWT in parallel with co-designed implementation strategies and resources across four major pediatric hospitals. We will conduct a multi-center, prospective, stepped-wedge cluster randomized controlled trial to implement adjunctive NPWT for acute pediatric burns. Participants will include pediatric burn patients presenting to one of four Australian tertiary pediatric hospitals for burn treatment. The intervention is adjunctive NPWT in parallel with co-designed and tailored implementation strategies and a suite of NPWT implementation resources, which form the INPREP toolkit. Using a hybrid type III design, this trial aims to evaluate the effectiveness of NPWT implementation in parallel with the INPREP toolkit using (i) implementation outcomes (e.g., adoption, appropriateness, acceptability, feasibility, and sustainability) and (ii) clinical outcomes (e.g., days to re-epithelialization, scar management requirements, skin grafting requirements). The primary outcome of this trial is treatment adoption-the proportion of eligible patients who receive NPWT. This manuscript outlines a protocol for a hybrid type III stepped-wedge cluster randomized controlled trial of adjunctive NPWT implementation in acute pediatric burn care. We anticipate that NPWT implementation in parallel with the INPREP toolkit will be generalizable to emergency departments and burn services across Australia, and evidence generated will inform pediatric burn care internationally. Australian and New Zealand Clinical Trials Registry: ACTRN12622000166774. Registered 1 February 2022.
Hospital-to-home care transition program for deep partial-thickness burns: improved scar outcomes and quality of life
Scar formation, the most common complication of burns, significantly impacts patients’ quality of life. This study evaluates how the hospital-to-home care transition program reduces scar-related complications and improves health-related quality of life in patients with deep partial-thickness burns. This semi-experimental study involved 80 patients with deep partial-thickness burns, selected through convenience sampling and randomly assigned—by coin flipping—to the intervention group ( n  = 40) or the control group ( n  = 40). We used the Patient and Observer Scar Assessment Scale and the Burn Specific Health Scale-Brief to assess outcomes. The hospital-to-home care transition program was delivered to the intervention group through three face-to-face educational sessions during discharge from the emergency department and clinic visits, along with two telephone counseling and follow-up sessions in the second and third weeks post-discharge. Data collection occurred at three time points: baseline, the third week after emergency department discharge, and the 12th week post-discharge. We analyzed the data using SPSS v.22 with a significance level set at 0.05. The findings showed that time and group each contributed to reducing scars by 5.71 and 8.81 units, respectively, with an interactive effect of 5.22 units ( P  < 0.001). Similarly, time and group individually improved health-related quality of life by 21.68 and 26.74 units, respectively, with an interactive improvement of 24.71 units ( P  < 0.001). The results indicate that the hospital-to-home care transition program helped prevent excessive scar complications and promoted a more favorable scar maturation process, thereby enhancing health-related quality of life in patients with deep partial-thickness burns. Nurses and healthcare planners can apply these findings to improve outcomes for this patient group.
Efficacy and safety of platelet-rich plasma as an adjunct therapy to split thickness skin graft in burn patients with granulating raw wounds: a prospective, randomized, double-blind study—study protocol
Background Burn wounds are commonly encountered in clinical settings and the management aims at the prevention of mortality and morbidity due to disability. The platelet-rich plasma (PRP) is blood-derived biomaterial that is enriched with growth factors and cytokines that facilitate wound healing. The PRP has proven its efficacy in various other wounds, but its role in post-burn raw areas and graft take has not been validated. This proposed multicentre randomized controlled trial aims to evaluate the efficacy and safety of platelet-rich plasma as an adjunct therapy to split-thickness skin graft in burn patients with granulating raw wounds. Method/design This trial is an investigator-initiated, double-blind multicentre, randomized controlled parallel arm trial alongside trial cost-effectiveness analysis. Granulating deep second-degree and third-degree burns affecting 3–20% of total body surface area (TBSA) at 10–14th post-burn day will be included in the study. A total of 550 patients (275 in each group) will be randomized to receive either standard skin graft or allogenic PRP with skin graft treatment. The primary endpoint will be the mean percentage of graft-take on the 14th postoperative day. The result will be analyzed by two independent assessors who are blinded to the study. Secondary endpoints include (a) time taken for complete wound healing; (b) frequency of adverse events; (c) follow-up with scar index at 3 months, 6 months, and 1 year using the Patient and Observer Scar Assessment Scale (POSAS) score; (d) cost-effectiveness analysis of the intervention compared to the comparator; and (e) to estimate in a subset of participants the association between growth factor levels (PDGF BB and TGF ß-1) of activated PRP and clinical response. Discussion The proposed trial will be expected to verify the efficacy and safety of PRP for split-thickness skin graft (STSG) in deep second-degree or third-degree granulating wounds of burn patients based on the outcome of the study.