Management of a complicated colonexposed sacrococcygeal wound after pelvic exenteration: a case report.

DECLARATION OF INTEREST: This work was supported by the Naval Medical University and the University of Shanghai for Science and Technology Joint Projects (2020-RZ04), the Innovative Clinical Research Program of Shanghai Changzheng Hospital (2020YLCYJ-Y16), and the academic project of Naval Medical University (2022QN073). The authors have no conflicts of interest to declare.

Wellbeing, quality of life and satisfaction of patients with hard-to-heal wounds: a descriptive study.

OBJECTIVE: A hard-to-heal wound is defined as a wound that failed to proceed through the normal phases of wound healing in an orderly and timely manner. The purpose of this article is to describe the impact of hard-to-heal wounds on the wellbeing, quality of life (QoL) and satisfaction with QoL of patients in Oman with hard-to-heal wounds. METHOD: A descriptive cross-sectional study of patients with hard-to-heal wounds attending three tertiary care hospitals using a self-reported questionnaire was conducted. RESULTS: A total of 275 patients took part in the study. Patients reported a low wellbeing score (67.06±19.72), moderate QoL score (52.18±25.07) and moderate satisfaction scores (68.91±23.88). Significant mean differences were reported with age, sex, educational level, monthly income and type of wound all at p<0.05. CONCLUSION: The findings of this study demonstrated that hard-to-heal wounds could influence the wellbeing, QoL and overall satisfaction with QoL of patients. DECLARATION OF INTEREST: Funding was received through an internal grant of the Sultan Qaboos University to conduct the research conducting the research (IG/CON/FACN/20/01). The authors have no conflicts of interest to declare.

Pressure ulcers related to prone positioning: a pandemic amidst a pandemic.

OBJECTIVE: To explore the epidemiology and risk factors associated with the development of pressure ulcers (PUs) in patients receiving prone positioning (PP) ventilatory therapy; to compare the inflammatory status of patients who develop PUs with those who do not; and to describe the experience and useful findings that have allowed us to improve the management of these patients to reduce the incidence of PUs. METHOD: An observational, descriptive and longitudinal study was conducted, where sociodemographic and laboratory data were collected from patients who were hospitalised and required PP ventilatory therapy in critical care areas (CCA) during the months of May-October 2020. RESULTS: From the total number of patients who required PP during their CCA stay (n=240), 202 (84.2%) developed a PU. The four most frequent areas where a PU appeared were: the head and neck (n=115); the pinna (n=21); the torso (n=21); and the lower limbs (n=21). Patients who developed PU were more frequently males with higher initial levels of creatinine phosphokinase and ferritin. The incidence for each month of follow-up decreased from 8.3% to 5.8%. CONCLUSION: Regardless of the intervention, a multidisciplinary approach is required to optimise the prevention and treatment of these wounds. While PUs are often the result of other medical conditions or poor health status in general, the vast majority of PUs are avoidable.

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.

Utilization of Split-Thickness Skin Graft as a Treatment Option Following Mohs Micrographic Surgery.

Split-thickness skin grafting (STSG) is a frontline treatment for challenging surgical wounds, including diabetic foot ulcers, venous leg ulcers, and post-surgical defects. This study explores the use of STSG employing the pinch graft technique for hard-to-heal surgical wounds following Mohs micrographic surgery (MMS). An 83-year-old patient with a non-improving post-MMS defect on the left lower leg underwent STSG from the right inner thigh using the pinch graft technique. The grafts were secured with a mesh dressing, adhesive strips, and compression bandaging. The patient experienced complete re-epithelialization and reduced pain within five weeks, emphasizing the efficacy of STSG for challenging cases. This case underscores the importance of considering STSG, especially in challenging locations, as a rapid and efficient treatment with improved quality of life. The pinch graft technique is presented as a useful option following MMS. This study encourages Mohs surgeons to consider STSG for reconstruction in challenging locations, especially on the lower leg.

Evaluation of risk factors associated with hard-to-heal wound infection in a tertiary care hospital.

OBJECTIVE: The incidence of hard-to-heal wound infection, especially as a result of multidrug-resistant Gram-negative organisms, has increased in recent years. The reason for the increase is multifactorial and the ability of these pathogenic isolates to form biofilms is one of the important risk factors in wound infection. This study aimed to evaluate the risk factors associated with such cases. METHOD: This prospective analytical study, conducted over a period of two months, included pus or tissue samples from hospital inpatients with Gram-negative hard-to-heal wound infection. The samples were processed with conventional microbiological techniques. Patient demographic details and the presence of various risk factors were recorded. Biofilm production was detected by tissue culture plate method in the laboratory. The data were analysed using SPSS version 21 (IBM Ltd., US). RESULTS: The experimental cohort comprised 200 patients. Klebsiella spp. was the most common identified organism, followed by Escherichia coli and Pseudomonas spp. Carbapenem resistance was observed in 106 (53%) strains. Almost 66% of the strains showed biofilm formation. On evaluation of associated risk factors, age (p=0.043), presence of biofilms (p=0.0001), diabetes (p=0.002), hypertension (p=0.02) and medical device use (p=0.008) had significant association, whereas sex, previous surgery and prior antibiotic use had no significant impact on the chronicity of the wound. CONCLUSION: In this study, chronicity of wounds was observed to be associated with multiple risk factors, especially the biofilm-forming ability of the strain. Biofilms are difficult to eradicate and additional measures, such as physical debridement, are important for resolving chronicity. Knowledge about specific risk factors would also allow clinicians a better understanding of the healing process and drive appropriate wound care interventions. DECLARATION OF INTEREST: A grant was received from the Indian Council of Medical Research (ICMR) for this work (grant ID: 2017-02686). The authors have no conflicts of interest to declare.

A rare case of a hard-to-heal ulcer caused by pulmonary Nocardia infection.

DECLARATION OF INTEREST: The authors have no conflicts of interest.

A double-blind trial comparing an antimicrobial combination to standard care in hard-to-heal wounds.

OBJECTIVE: Excessive numbers of bacteria in hard-to-heal wounds impede wound healing. Numerous topical antiseptics have demonstrated effectiveness in benchtop studies; however, few clinical studies have demonstrated efficacy in the target population: patients with hard-to-heal wounds. This study addressed the clinical efficacy of a novel antibiofilm cleanser and gel in reducing bacterial load and improving wound outcomes. METHOD: Hard-to-heal wounds were photographed, measured and evaluated for bacterial load using fluorescence imaging weekly for four weeks. The target ulcers were randomised to be cleaned and treated with either a synergistic antibiofilm cleanser and antibiofilm gel with standard of care (AMC-AMG + SoC) or normal saline wash and an amorphous gel with standard of care (NSS-HG + SoC). RESULTS: A Chi-squared test of independence determined that the relationship between the treatment and the patient reaching 40% percentage area reduction (PAR) in four weeks was not significant (χ2(1, n=54)=0.73; p=0.39 at a significance level of 0.05); however, there was a strong trend favouring the antibiofilm cleanser and gel. A significant reduction (p<0.05) in bacterial load was observed in the antibiofilm group. CONCLUSION: This randomised controlled double-blind proof-of-concept study suggests that the performance of antibiofilm agents in vivo is comparable to that in vitro studies.

The role community-based healthcare providers play in managing hard-to-heal wounds.

It is common for community-based healthcare providers (CHPs)-many of whom have not received specialised training in wound care-to deliver initial and ongoing management for various wound types and diverse populations. Wounds in any setting can rapidly transition to a stalled, hard-to-heal wound (HTHW) that is not following a normal healing trajectory. Failure to recognise or address issues that cause delayed healing can lead to increased costs, healthcare utilisation and suffering. To encourage early intervention by CHPs, a panel of wound care experts developed actionable evidence-based recommendations for CHPs delineating characteristics and appropriate care in identifying and treating HTHWs. A HTHW is a wound that fails to progress towards healing with standard therapy in an orderly and timely manner and should be referred to a qualified wound care provider (QWCP) for advanced assessment and diagnosis if not healed or reduced in size by 40%-50% within 4 weeks. HTHWs occur in patients with multiple comorbidities, and display increases in exudate, infection, devitalised tissue, maceration or pain, or no change in wound size. CHPs can play an important initial role by seeing the individual's HTHW risk, addressing local infection and providing an optimal wound environment. An easy-to-follow one-page table was developed for the CHP to systematically identify, evaluate and treat HTHWs, incorporating a basic toolkit with items easily obtainable in common office/clinic practice settings. A flow chart using visual HTHW clinical cues is also presented to address CHPs with different learning styles. These tools encourage delivery of appropriate early interventions that can improve overall healthcare efficiency and cost.

Development and validation of a Chinese version chronic wound health-related quality of life instrument: A methodological study.

AIMS AND OBJECTIVES: To develop a Chinese version of a chronic wound health-related quality of life (QoL) instrument and to examine the psychometric properties of this instrument. BACKGROUND: Existing QoL instruments are not tailored to the linguistic and cultural characteristics of Chinese-speaking patients; a version addressing this gap will increase clinical understanding of their healthcare experience and may help guide chronic wound care. DESIGN: A methodological study. METHODS: The method advanced by DeVellis (2017) was used to develop the instrument. An initial pool of 38 items was created. To optimize scale length and test reliability and validity, exploratory and confirmatory factor analyses were conducted. A total of 23 items formed the final pool. After two rounds of expert discussions, the average content validity index of the final 23 items was .89. RESULTS: A total of 226 patients completed the instrument and were divided into two groups for further analysis. Exploratory factor analysis revealed that 15 items remained in four factors (social activity restrictions, physical and psychological disturbance, wound burden and daily life limitation), which accounted for 64.87% of the variance. Confirmatory factor analysis revealed an acceptable fit of the hypothesized factor structure and the convergent and discriminant validities were achieved. Cronbach's α coefficients for each factor were .807, .773, .799 and .713, respectively. CONCLUSION: The Chinese version of a chronic wound health-related QoL instrument consists of 15 items in four subscales and demonstrates good reliability and validity. RELEVANCE TO CLINICAL PRACTICE: This instrument can be used intermittently or continuously to evaluate the treatment effect of chronic wounds by assessing health-related QoL. Scholars in Chinese-speaking regions may find this culturally compatible instrument useful when conducting studies related to chronic wounds. PATIENT OR PUBLIC CONTRIBUTION: Two hundred twenty-six participants provided their perspectives on health-related QoL.

Hard-to-Heal Wound Healing: Superiority of Hydrogel EHO-85 (Containing Olea europaea Leaf Extract) vs. a Standard Hydrogel. A Randomized Controlled Trial.

Chronic wounds, especially those that are hard-to-heal, constitute a serious public-health problem. Although progress has been made in the development of wound dressings for healing, there is little high-quality evidence of their efficacy, with no evidence of superiority in the use of one hydrogel over another. To evaluate the superiority of a hydrogel (EHO-85), containing Olea europaea leaf extract (OELE), over a standard hydrogel (SH), the promotion and/or improvement of healing of difficult-to-heal wounds was compared in a prospective, parallel-group multicenter, randomized, observer-blinded, controlled trial ("MACAON"). Non-hospitalized patients with pressure, venous or diabetic foot-ulcers difficult-to-heal were recruited and treated with standard care, and EHO-85 (n = 35) or VariHesive (n = 34) as SH. Wound-area reduction (WAR; percentage) and healing rate (HR; mm2/day) were measured. EHO-85 showed a statistically significant superior effect over VariHesive. At the end of the follow-up period, the relative WAR decreased by 51.6% vs. 18.9% (p < 0.001), with a HR mean of 10.5 ± 5.7 vs. 1.0 ± 7.5 mm2/day (p = 0.036). EHO-85 superiority is probably based on its optimal ability to balance the ulcer bed, by modulating pH and oxidative stress. That complements the wetting and barrier functions, characteristics of conventional hydrogels. These results support the use of EHO-85 dressing, for treatment of hard-to-heal ulcers. Trial Registration AEMPS:PS/CR623/17/CE.

Use of chitosan wound dressing for the treatment of surgical site infection: a case report.

Surgical site infections (SSIs) are treated using topical antiseptics and systemic antibiotics, but some cases are unresponsive to such regimens. This case study reports the effective healing of an SSI by a chitosan wound dressing (MaxioCel; Axio Biosolutions Private Limited, India) in a 63-year-old female patient. The patient presented with an infected, hard-to-heal wound in the abdominal region, developed after a hernia surgery, and was initially treated with standard procedures. However, due to the continuous progression of infection, a highly absorbent, bioactive microfibre dressing was selected for the treatment and was continued for two months with alternate-day dressing changes. After 60 days of treatment, wound healing was observed, along with remission from the infection, as well as reduction in exudate level and pain. The use of chitosan wound dressing in management of hard-to-heal infected wounds provides efficient remission of SSI and a faster healing rate.

An observational study of wounds treated with hydro-responsive wound dressings.

OBJECTIVE: Acute and hard-to-heal wounds are a significant burden to both a patient's quality of life and resources in healthcare systems. Here, we evaluate the outcomes of a non-comparative case series study in which Ringer's solution-preactivated polyacrylate dressings were used to treat acute and hard-to-heal wounds (the presence of Ringer's solution provides a wound dressing that allows, upon application, the immediate hydration of the underlying wound tissue). METHOD: Patients with acute and hard-to-heal wounds were enrolled into an open-labelled, non-comparative observational study. Patients were treated with Ringer's solution-preactivated polyacrylate dressings to enable wound debridement and wound cleansing for up to 12 weeks. RESULTS: A total of 303 patients were enrolled in the study and 278 were included in the analysis. Wound size decreased, from a median of 3.6cm2 (interquartile range (IQR): 1.2-9.3] at baseline to a median of 2.6cm2 (IQR: 1.1-7.8] at 84 days. Relative wound area reduction (WAR) was 43.1% at 84 days and estimated probability of achievement of a WAR of ≥40% and ≥60% was 68.7% and 53.4%, respectively. Median time to achieve a WAR of ≥40% and ≥60% was 54 days and 75 days, respectively. The median percentage of wound area covered by fibrin had decreased from 50.0% to 10% and granulation tissue had increased from 25% to 50% after 84 days. In addition, periwound skin condition, local signs of infection and pain all showed improvement. The majority of the wounds were assessed as 'healed' or 'better' at the conclusion of the evaluation period. CONCLUSION: Based on the findings of this study, the use of Ringer's solution-preactivated polyacrylate dressings in daily practice has the potential to improve clinical outcomes, including healing, in patients with acute and hard-to-heal wounds.

Pyoderma gangrenosum and dehydrated human amnion/chorion membrane: a potential tool for an orphan disease.

OBJECTIVE: Pyoderma gangrenosum (PG) is an often-misdiagnosed, painful, inflammatory and ulcerative skin disorder. It is an orphan disease, where standard wound treatments such as sharp surgical debridement are contraindicated. This retrospective case series sought to evaluate the application of dehydrated human amnion/chorion membrane (DHACM) as a skin substitute in cases that were refractory to a range of standard-of-care techniques. METHOD: This retrospective case series involved wounds which failed to close with standard escalating treatments, including anti-inflammatory and immunosuppressive therapies. Subjects were transitioned to DHACM and wound sizes were monitored until closure. RESULTS: Wounds (n=5) for all three subjects had stalled with standard therapies for at least 2.5 months but responded quickly to routinely applied DHACM treatments, and closure was achieved in each case. CONCLUSION: This retrospective pilot case series examined the use of DHACM as an alternative wound treatment for PG patients failing standard therapies. DHACM treatments re-initiated the trajectory towards wound closure for each stalled PG ulcer. The results suggest a treatment algorithm starting with early recognition, wound closure via treatment escalation, and lastly a gradual reduction in treatment for durable closure. DHACM treatment should be formally evaluated as an adjunct to PG ulcers that have remained refractory to more commonly used immunomodulating therapies.

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.

Effectiveness of combined modulated ultrasound and electric current stimulation to treat diabetic foot ulcers.

OBJECTIVE: The use of combined ultrasound and electrostimulation (CUSECS) as an adjunct therapy for diabetic foot ulcers (DFUs) is a relatively new concept. This study aimed to investigate if combined ultrasound and electrostimulation is an effective adjunctive treatment for hard-to-heal DFUs when compared with standard wound care. METHODS: A randomised controlled pilot study design was used. Patients with hard-to-heal DFUs from two centres were sequentially randomised. For 8 weeks, the experimental group received CUSECS and standard wound care treatment twice a week. The control group received standard wound care treatment once a week. Wound changes were documented using photography, which also facilitated wound size measurement. Self-efficacy, economic cost, quality of life and reoccurrence rates were analysed as secondary objectives. RESULTS: The experimental group (n=6) achieved a higher rate of mean wound healing (mean difference (MD): 0.49) when compared to the control group (n=5, MD: 0.01). Two participants completed full healing in the experimental group and one in the control group. There were no statistically significant findings because of the small sample size. There were no direct adverse reactions to this therapy. Quality of life scores improved in the treatment group. There was no significant change in self-efficacy scores. Costs were higher in the experimental group; however, the healing rate was quicker, which could be extrapolated to cost reductions over time. CONCLUSION: Results suggest that CUSECS may be a useful adjunctive therapy for treatment of hard-to-heal DFUs. Further large-scale studies are needed to ascertain the effectiveness of CUSECS. The findings here are inconclusive but indicate that CUSECS may offer promise as a treatment.

Wound bed preparation with hypochlorous acid oxidising solution and standard of care: a prospective case series.

OBJECTIVE: This prospective case series aims to evaluate the clinical impact of a hypochlorous acid oxidising solution (AOS) in association with usual standard of care (SoC) on wound bed preparation (WBP) in patients with hard-to-heal ulcers of various aetiologies. The AOS (Nexodyn, APR Applied Pharma Research S.A., Switzerland) comprises three main features: highly pure and stabilised hypochlorous acid, acidic pH and high reduction-oxidation potential. METHOD: Between February 2015 and February 2017, patients who met the inclusion criteria were treated with AOS and usual SoC. Data collection ran for 70 days: T0-T70. A baseline assessment was undertaken at T0; parameters assessed at fortnightly visits included: WBP score, area and depth of ulcer, duration, pain, Bates-Jensen score and infection status. RESULTS: A total of 60 patients took part in the study. By T70, 68.3% of wounds had healed or improved and a significant wound size reduction of 21% was observed (p<0.001), despite a mean wound duration of 20.6 months. All wounds were free of local infection and cellulitis; 10% were colonised. WBP scores improved, while Bates-Jensen and pain scores fell significantly over time. CONCLUSION: This evaluation suggests that AOS might represent a valuable therapeutic addition for an optimal WBP in the routine management of hard-to-heal ulcers of different aetiologies. DECLARATION OF INTEREST: ER worked as a consultant for APR Applied Pharma Research S.A. The authors have no other conflicts of interest.

Hard-to-heal ulcers treated with hypochlorous acid oxidising solution and standard of care: a 32-week follow-up.

OBJECTIVE: Immediately following a two-year prospective case series in which the wounds of 60 patients with hard-to-heal ulcers were treated with a hypochlorous acid oxidising solution (AOS) in addition to standard of care (SoC) for 70 days (T0-T70), a subset of 31 patients (51.7%) whose wounds had not fully healed by T70 opted to continue with treatment for a further 22 weeks (days T70-T224, a total treatment time of 32 weeks (224 days). The objective was to provide long-term evidence on the clinical performance and safety of AOS when used in association with the usual SoC in patients with stalled, hard-to-heal ulcers of various aetiologies. METHOD: As per the main study, wounds were formally assessed by the study lead at 28 days (±14 days, depending on patient attendance). Parameters assessed at fortnightly visits included area, depth and duration of ulcer; pain; wound bed preparation (WBP) score; and infection status. Wounds were managed in accordance with the SoC protocol. RESULTS: By T224, 35.5% (n=11) of wounds healed completely and 83.9% showed some types of improvement. All wounds were free of infection and colonisation, the WBP score improved (100% A1-A2 at T196), and pain scores fell. Use of AOS in combination with several types of dressing (SoC) for such a long period confirmed a good safety profile. CONCLUSION: This follow-up evaluation, coupled with the primary study, suggests that AOS might represent a valuable therapeutic addition for the management of hard-to-heal ulcers for long periods of treatment. DECLARATION OF INTEREST: ER worked as a consultant for APR Applied Pharma Research S.A. The authors have no other conflicts of interest.

Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled clinical trial.

OBJECTIVES: Perfusion and blood oxygen levels are frequently insufficient in patients with hard-to-heal wounds due to poor circulation, vascular disruption and vasoconstriction, reducing the wound's capacity to heal. This study aimed to investigate the effect of topical oxygen on healing rates in patients with hard-to-heal diabetic foot ulcers (DFUs) (i.e., non-responsive over four weeks). METHOD: This multicentre, open-label, community-based randomised clinical trial compared standard care (SOC) with or without continuous topical oxygen therapy (TOT) for 12 weeks in patients with DFUs or minor amputation wounds. SOC included debridement, offloading with total contact casting (TCC) and appropriate moisture balance. Primary endpoints were the number of patients to achieve complete wound closure and percentage change in ulcer size. Secondary endpoints were pain levels and adverse events. RESULTS: For the study, 145 patients were randomised with index ulcers graded Infectious Diseases Society of America (IDSA) 1 or 2, or Wagner 1 or 2. In the intention-to-treat analysis, 18/64 (28.1%) patients healed in the SOC group at 12 weeks compared with 36/81 (44.4%) in the SOC plus TOT group (p=0.044). There was a statistically significant reduction in wound area between the groups: SOC group mean reduction: 40% (standard deviation (SD) 72.1); SOC plus TOT group mean reduction: 70% (SD 45.5); per protocol p=0.005). There were no significant differences in changes to pain levels or adverse events. CONCLUSION: This study suggests that the addition of TOT to SOC facilitates wound closure in patients with hard-to-heal DFUs.

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.