A Diagnostic-Driven Prospective Clinical Study Evaluating the Combination of an Antibiofilm Agent and Negative Pressure Wound Therapy.

BACKGROUND: Each year, millions of Americans develop truncal pressure ulcers (PUs) which can persist for months, years, or until the end of life. Despite the negative impact on quality of life and escalating costs associated with PUs, there is sparse evidence supporting validated and efficacious treatment options. As a result, treatment is based on opinion and extrapolation from other wound etiologies. The ideal reconstructive plan maximizes the patient's nutritional status, incorporates the basic tenets of wound bed preparation (debridement, offloading, proper moisture balance, reduction of bacterial burden), and employs diagnostics to guide therapeutic intervention. The use of combination therapies can potentially overcome several of the barriers to wound healing. Negative pressure wound therapy (NPWT), a commonly used modality in the management of PUs, facilitates healing by stimulating the formation of granulation tissue and promoting wound contraction; however, NPWT alone is not always effective. Clinical studies examining microbial bioburden in PUs determined that most ulcers contain bacteria at levels that impede wound healing (>104 CFU/g). OBJECTIVE: Thus, we hypothesized that adding an anti-microbial agent to decrease both planktonic and biofilm bacteria in the wound would increase the efficacy of NPWT. METHOD: In this prospective study, twenty patients with recalcitrant PUs that previously failed NPWT were treated with a biofilm-disrupting agent (Blast-X, Next Science, Jacksonville, FL, USA) in combination with NPWT. Fluorescence imaging was used to follow bacterial burden and guide therapy. RESULTS: In total, 45% of the PUs reduced in size over the course of the four-week study, with a resolution of bacterial fluorescence in the NPWT dressing and wound bed seen in an average of three weeks. CONCLUSION: The combination of an antibiofilm agent and NPWT reduced bacterial levels and improved wound healing in recalcitrant PUs.

Inpatient peritoneal dialysis catheters placed across the United States during a 3-year period: Lessons learned from 15,000 patients.

BACKGROUND: Peritoneal dialysis is a popular option for patients with end-stage renal disease. A recent presidential executive order has incentivized in-home end-stage renal disease treatments, leading to an increase in peritoneal dialysis use. Guidelines exist for creating and maintaining peritoneal dialysis access without addressing the optimal technique. This study evaluates nationwide peritoneal dialysis catheter placement practices and their long-term outcomes. METHODS: Retrospective cohort analysis of Nationwide Readmission Database from 2017 to 2019. Patients with end-stage renal disease undergoing inpatient peritoneal dialysis catheter placement were included. Six-month readmissions, mortality, and peritoneal dialysis catheter-specific outcome measures were assessed among survivors of admission, including catheter leakage, mechanical breakdown, displacement, revision or replacement, removal, exit site infections, intra-abdominal abscess, and sepsis. Binary logistic regression analyses were performed. RESULTS: In the study, 14,863 patients with inpatient peritoneal dialysis catheter insertions were identified, of which 7,096 were analyzed (4,150 [59%] laparoscopic, 1,781 [25%] fluoroscopic, 1,165 [16%] open), 847 (12%) had major complications, 931 (13%) were readmitted, and 102 (1.4%) died within 6 months. Univariate analyses demonstrated that laparoscopy had higher mechanical complications, exit-site infections, catheter revision, and removal within 6 months, and fluoroscopy had higher sepsis and mortality. Multivariate analyses showed fluoroscopy was associated with intraabdominal abscess (adjusted odds ratio, 2.36; P = .025), laparoscopy with exit-site infections (adjusted odds ratio, 0.49; P = .005), and open surgery with catheter displacement (adjust odds ratio, 2.95; P = .021). CONCLUSION: This is the first large-scale study on inpatient peritoneal dialysis catheter placement outcomes in the United States. Fluoroscopic and open surgical placements are routinely performed, but laparoscopy remains the mainstay with fewer exit-site infections. Overall, peritoneal dialysis is a safe option, with 1 in 9 patients having an infectious or mechanical complication within 6 months. Furthermore, large-scale prospective studies are warranted to identify the optimal placement technique.

A multicenter clinical trial evaluating the durability of diabetic foot ulcer healing in ulcers treated with topical oxygen and standard of care versus standard of care alone 1 year post healing.

Multiple clinical trials and real-world studies have demonstrated accelerated healing in diabetic foot ulcers (DFU) treated with advanced modalities, such as topical oxygen therapy (TOT). In addition to healing, the durability of wound closure is a crucial long-term endpoint for DFU clinical trials: an advanced treatment that does not confer a reasonable ulcer-free period will have limited clinical benefit and modest economic value. Preclinical studies suggest that DFUs receiving topical oxygen therapy will experience improved quality of healing: increased collagen deposition and angiogenesis. It is postulated that these changes will translate into a more long-lasting closure for ulcers treated with TOT and SOC compared to ulcers treated with SOC alone. At the conclusion of a recently completed randomised controlled DFU clinical trial evaluating the efficacy of TOT and SOC compared to SOC alone, patients with healed ulcers were asked to enrol in a long-term follow-up study. Healed patients completed four questionnaires through text messages or phone calls within 1-year post completion of the trial. Twenty-nine patients consented to participate in the long-term follow-up trial (17 TOT/SOC and 12 SOC). Only seven subjects were lost to follow up (5 TOT and 2 SOC). This is a surprisingly low number when factoring in the disruption caused by the COVID-19 pandemic that continued throughout the entire follow-up period. In the remaining patients, 85% of the TOT patients and 60% of the SOC remained healed at 1 year. There was one major amputation, which occurred in an SOC-treated patient. The numbers in the long-term follow-up were too small to reach statistical significance; however, there is a strong trend toward more durable closure in ulcers treated with TOT.

The efficacy of sodium hypochlorite antiseptic: a double-blind, randomised controlled pilot study.

OBJECTIVE: According to a recent clinical trial, 82% of hard-to-heal wounds harbour levels of bacteria that impede healing. A follow-up analysis of trial data revealed that the use of antiseptic cleansers did not correlate with bacterial burden. At a minimum, these findings suggest the need for clinical research into the efficacy of antiseptics in reducing bacterial burden. Evidence supporting the bacterial killing ability of antiseptics is largely derived from preclinical and laboratory studies. Few clinical trials have examined bacterial levels and healing rates in hard-to-heal wounds. Fortunately, the advent of fluorescence imaging to detect bacterial burden has simplified the conduct of clinical research examining the effectiveness of antiseptics in the clinic setting. The aim of this study was to evaluate the efficacy of a modified sodium hypochlorite (NaOCl) solution in reducing wound size and bacterial load in hard-to-heal wounds. METHOD: In this randomised, double-blind pilot study, patients were randomised to one of two groups: daily wound cleansing with either normal saline solution (NSS) or NaOCl. Patients and investigators were blinded to the allocation. All wound types were included. RESULTS: A total of 16 patients consented to participate. At the initial visit, the target ulcer was measured and a fluorescence image to evaluate bacterial load obtained. The wound was then cleansed with either NSS or NaOCl and fluorescence imaging repeated. Patients cleansed the wound daily in accordance with the randomisation schedule. They returned to the clinic weekly for four weeks, and on each visit the wound was measured and a fluorescence image captured. Patients receiving NaOCl had a greater percent reduction in wound area versus NSS; although the first phase of the study was not powered for statistical significance, there was a strong trend favouring NaOCl. In addition, there was greater bacterial reduction in the NaOCl group. CONCLUSION: Based on the results of this pilot study, enrolment has continued in order to increase the study's power. This pilot study suggests that sodium hypochlorite is efficacious in reducing bacterial burden and promoting healing.

Uncovering the high prevalence of bacterial burden in surgical site wounds with point-of-care fluorescence imaging.

Detection of bacterial burden within or near surgical wounds is critical to reducing the occurrence of surgical site infection (SSI). A distinct lack of reliable methods to identify postoperative bioburden has forced reliance on clinical signs and symptoms of infection (CSS). As a result, infection management has been reactive, rather than proactive. Fluorescence imaging of bacterial burden (FL) is positioned to potentially flip that paradigm. This post hoc analysis evaluated 58 imaged and biopsied surgical site wounds from the multi-centre fluorescence imaging assessment and guidance clinical trial. Diagnostic accuracy measures of CSS and FL were evaluated. A reader study investigated the impact of advanced image interpretation experience on imaging sensitivity. Forty-four of fifty-eight surgical site wounds (75.8%) had bacterial loads >104  CFU/g (median = 3.11 × 105  CFU/g); however, only 3 of 44 were CSS positive (sensitivity of 6.8%). FL improved sensitivity of bacterial detection by 5.7-fold compared with CSS alone (P = .0005). Sensitivity improved by 11.3-fold over CSS among clinicians highly experienced with FL interpretation (P < .0001). Surgical sites that reach the stage of referral to a wound specialist frequently harbour asymptomatic high bacterial loads that delay healing and increase infection risk. Advanced imaging of pathological bacterial burden improves surgical site monitoring and may reduce the rate of SSIs.

A novel debridement device for the treatment of hard-to-heal wounds: a prospective trial.

OBJECTIVE: Debridement, the removal of nonviable tissue, forms the foundation of wound care practice. Clinicians have a variety of debridement methods at their disposal: sharp, biologic, enzymatic, autolytic and mechanical. The choice of debridement technique depends on the patient care setting, ulcer type and the clinician's experience, training, comfort level and licensure. This prospective study evaluated a novel debridement instrument, EZ-Debride (MDM Ventures, US). Cutting flutes on the head of the tool permit uniform removal of dead tissue while lessening the risk of deeper injury. It may also minimise pain during the debridement procedure. METHOD: Subjects with hard-to-heal wounds, drawn from a single wound care centre, participated in this institutional review board-approved prospective clinical study. Pain was measured before, during and after debridement using a numerical scale. Assessment of bacterial burden using fluorescence imaging (MolecuLight, Canada) was performed before and after debridement. RESULTS: Enrolment of 10 male and 12 female subjects, with a total of 28 wounds, was carried out over a two-month period by two investigators at a single institution. The average age of subjects was 64 years (range: 22-95 years). The average wound duration was 29 weeks (range: 6-142 weeks). Wound types included diabetic foot, venous leg and pressure ulcers, post-surgical and traumatic wounds. The average pain score at the time of enrolment was 3.9. Subjects reported an average increase in pain with debridement of 0.6 points (range: 0-8). Fluorescence imaging demonstrated a reduction in bacterial load in 69% of cases, with complete resolution in 19% of wounds. Haemostasis was achieved with direct pressure in all cases and the only adverse event was a wound infection that occurred four days after debridement. CONCLUSION: The results suggest that this novel debridement tool can safely remove nonviable tissue with minimal discomfort and reduce bacterial burden similar to results achieved by sharp debridement.