The cost‐benefit of using soft silicone multilayered foam dressings to prevent sacral and heel pressure ulcers in trauma and critically ill patients: a within‐trial analysis of the Border Trial

Little is known about the cost‐benefit of soft silicone foam dressings in pressure ulcer (PU) prevention among critically ill patients in the emergency department (ED) and intensive care unit (ICU). A randomised controlled trial to assess the efficacy of soft silicone foam dressings in preventing sacral and heel PUs was undertaken among 440 critically ill patients in an acute care hospital. Participants were randomly allocated either to an intervention group with prophylactic dressings applied to the sacrum and heels in the ED and changed every 3 days in the ICU or to a control group with standard PU prevention care provided during their ED and ICU stay. The results showed a significant reduction of PU incidence rates in the intervention group (P = 0·001). The intervention cost was estimated to be AU$36·61 per person based on an intention‐to‐treat analysis, but this was offset by lower downstream costs associated with PU treatment (AU$1103·52). Therefore, the average net cost of the intervention was lower than that of the control (AU$70·82 versus AU$144·56). We conclude that the use of soft silicone multilayered foam dressings to prevent sacral and heel PUs among critically ill patients results in cost savings in the acute care hospital.     

Soft silicone foam dressing is more effective than polyurethane film dressing for preventing intraoperatively acquired pressure ulcers in spinal surgery patients: the Border Operating room Spinal Surgery (BOSS) trial in Japan

Preventing intraoperatively acquired pressure ulcers (IAPUs) in patients undergoing spinal surgery in the prone position using a Relton‐Hall frame is challenging. We investigated the efficacy of soft silicone foam dressings in preventing IAPUs. A prospective dual‐center sham study was conducted among patients undergoing elective spinal surgery in a general hospital and a university hospital in Japan. The incidence of IAPUs that developed when soft silicone foam dressings and polyurethane film dressings were used was compared on two sides in the same patient. IAPUs developed on the chest in 11 of 100 patients (11%). Polyurethane film dressings were associated with a significantly higher rate of IAPUs than soft silicone foam dressings (11 versus 3, P = 0·027). A multivariate logistic regression analysis revealed that a diastolic blood pressure of <50 mmHg (P = 0·025, OR 3·74, 95% confidence interval [CI] 1·18–13·08) and the length of surgery (by 1 hour: P = 0·038, OR 1·61, 95% CI 1·03–2·64) were independently associated with the development of IAPUs. The use of soft silicone foam dressings reduced the risk of IAPUs (P = 0·019, OR 0·23, 95% CI 0·05–0·79) and was more effective than film dressings for preventing IAPUs in spinal surgery patients.     

The efficacy and safety of Grafix® for the treatment of chronic diabetic foot ulcers: results of a multi‐centre,controlled, randomised,blinded, clinical trial

In a randomised, controlled study, we compared the efficacy of Grafix^®, a human viable wound matrix (hVWM) (N = 50), to standard wound care (n = 47) to heal diabetic foot ulcers (DFUs). The primary endpoint was the proportion of patients with complete wound closure by 12 weeks. Secondary endpoints included the time to wound closure, adverse events and wound closure in the crossover phase. The proportion of patients who achieved complete wound closure was significantly higher in patients who received Grafix (62%) compared with controls (21%, P = 0·0001). The median time to healing was 42 days in Grafix patients compared with 69·5 days in controls (P = 0·019). There were fewer Grafix patients with adverse events (44% versus 66%, P = 0·031) and fewer Grafix patients with wound‐related infections (18% versus 36·2%, P = 0·044). Among the study subjects that healed, ulcers remained closed in 82·1% of patients (23 of 28 patients) in the Grafix group versus 70% (7 of 10 patients) in the control group (P = 0·419). Treatment with Grafix significantly improved DFU healing compared with standard wound therapy. Importantly, Grafix also reduced DFU‐related complications. The results of this well‐controlled study showed that Grafix is a safe and more effective therapy for treating DFUs than standard wound therapy.     

Manuka honey‐impregnated dressings in the treatment of neuropathic diabetic foot ulcers

In this study, we investigate the effect of manuka honey‐impregnated dressings (MHID) on the healing of neuropathic diabetic foot ulcers (NDFU). A total of 63 Caucasians, type 2 diabetic patients followed up in the diabetic foot outpatient clinic comprised the study population. Patients were randomised in two groups as follows: group I patients were treated with MHID and group II patients were treated with conventional dressings (CD). The patients were followed up on a weekly basis for 16 weeks. Mean healing time was 31 ± 4 days in group I versus 43 ± 3 days in group II (P < 0·05). In group I patients 78·13% of ulcers became sterile during the first week versus 35·5% in group II patients; the corresponding percentages for weeks 2, 4 and 6 were 15·62% versus 38·7%, 6·25% versus 12·9% and 0% versus 12·9% respectively. The percent of ulcers healed did not differ significantly between groups (97% for MHID and 90% for CD). MHID represent an effective treatment for NDFU leading to a significant reduction in the time of healing and rapid disinfection of ulcers.     

Efficacy and safety of a gauze pad containing hyaluronic acid in treatment of leg ulcers of venous or mixed origin: a double‐blind,randomised, controlled trial

Topical hyaluronic acid (HA) is routinely used in the local treatment of chronic wounds, but few data have been reported to date. A 60‐day double‐blind, randomised, controlled superiority trial was designed to investigate the efficacy and safety of a gauze pad containing HA in local treatment of venous leg ulcers, compared with its neutral vehicle. The primary endpoint was the percentage of wound size reduction after 45 days. Totally 89 patients were included. At day 45, the percentage of ulcer surface reduction was significantly greater in the HA group (73 ± 4·6%) versus neutral vehicle group (46 ± 9·6%) (P = 0·011). The number of healed ulcers was significantly higher in the HA group at day 45 (31·1% versus 9·3% respectively) and day 60 (37·8% versus 16·3% respectively; P < 0·05). At day 30, pain intensity based on visual analogue scale was significantly lower in the HA group (12·4 mm ± 2·6 versus 22·8 mm ± 3·8; P = 0·026). Tolerance of both treatments was comparable in the two groups. HA gauze pad, in local treatment of venous leg ulcers, was significantly more effective than the neutral vehicle on wound size reduction, healed ulcers rate and pain management with a good safety profile.     

A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix®) allograft for the treatment of venous leg ulcers

A randomised, controlled, multicentre clinical trial was conducted to evaluate the efficacy of dehydrated human amnion/chorion membrane (EpiFix) allograft as an adjunct to multilayer compression therapy for the treatment of non‐healing full‐thickness venous leg ulcers. We randomly assigned 109 subjects to receive EpiFix and multilayer compression (n = 52) or dressings and multilayer compression therapy alone (n = 57). Patients were recruited from 15 centres around the USA and were followed up for 16 weeks. The primary end point of the study was defined as time to complete ulcer healing. Participants receiving weekly application of EpiFix and compression were significantly more likely to experience complete wound healing than those receiving standard wound care and compression (60% versus 35% at 12 weeks, P = 0·0128, and 71% versus 44% at 16 weeks, P = 0·0065). A Kaplan–Meier analysis was performed to compare the time‐to‐healing performance with or without EpiFix, showing a significantly improved time to healing using the allograft (log‐rank P = 0·0110). Cox regression analysis showed that subjects treated with EpiFix had a significantly higher probability of complete healing within 12 weeks (HR: 2·26, 95% confidence interval 1·25–4·10, P = 0·01) versus without EpiFix. These results confirm the advantage of EpiFix allograft as an adjunct to multilayer compression therapy for the treatment of non‐healing, full‐thickness venous leg ulcers.     

Negative‐pressure wound dressings to secure split‐thickness skin grafts in the perineum

Several researches have shown that negative‐pressure wound dressings can secure split‐thickness skin grafts and improve graft survival. However, in anatomically difficult body regions such as the perineum it is questionable whether these dressings have similar beneficial effects. In this study, we evaluated the effects of negative‐pressure wound dressings on split‐thickness skin grafts in the perineum by comparing wound healing rate and complication rate with that of tie‐over dressings. A retrospective chart review was performed for the patients who underwent a split‐thickness skin graft to reconstruct perineal skin defects between January 2007 and December 2011. After grafting, the surgeon selected patients to receive either a negative‐pressure dressing or a tie‐over dressing. In both groups, the initial dressing was left unchanged for 5 days, then changed to conventional wet gauze dressing. Graft success was assessed 2 weeks after surgery by a single clinician. A total of 26 patients were included in this study. The mean age was 56·6 years and the mean wound size was 273·1 cm². Among them 14 received negative‐pressure dressings and 12 received tie‐over dressings. Negative‐pressure dressing group had higher graft taken rate (P = 0·036) and took shorter time to complete healing (P = 0·01) than tie‐over dressing group. The patients with negative‐pressure dressings had a higher rate of graft success and shorter time to complete healing, which has statistical significance. Negative‐pressure wound dressing can be a good option for effective management of skin grafts in the perineum.     

Systemic factors and mortality in elderly patients with pressure ulcers

The aim of this article was to identify specific systemic factors associated with existence of pressure ulcers (PUs) and the effect on survival from the time of admission. Patients admitted to the Skilled Nursing Department of the Herzog Hospital, Jerusalem, between 1 July 2008 and 31 December 2011. Of the 174 admitted patients (mean age: 77·4 ± 13·2 years), 107 (61·5%) had pre‐existing PUs and 67 (38·5%) did not have PUs. Major systemic factors were assessed for each patient at the time of admission: sociodemographic characteristics, comorbidities, use of urinary catheter, tube feeding and tracheostomy; nutritional state; Global Deterioration Scale, Glasgow Coma Scale and Norton Scale. Complications such as the number of provided antibiotic courses, and length and outcomes of hospitalisation were identified at the end of the study. In the univariate analysis, patients in the PU group had significantly prevalent characteristics including advanced age, low cognitive and consciousness function, low Norton scale, Parkinson's disease and anaemia due to chronic diseases, low nutritional parameters and higher number of antibiotics provided. Conditions that were associated with PUs in multiple regression analyses included advanced dementia (OR = 3·0, 95% CI: 1·4–6·3; P = 0·002), urinary catheter usage (OR = 2·25, 95% CI: 1·06–4·7; P = 0·03), low body mass index, BMI (OR = 0·92, 95% CI: 0·86–0·99; P = 0·02) and anaemia level (OR = 0·7, 95% CI: 0·58–0·9; P = 0·004). The median survival time of patients with PUs was significantly lower than the non PUs group (94 versus 414 days, respectively) (P = 0·005, log rank test). Length of stay was also significantly lower in the PU group (166 versus 270 days, P = 0·02). The existence of PUs may indicate a final common pathway of various systemic factors (geriatric conditions, diseases and frailty dysfunction).     

Randomized clinical trial of honey-impregnated dressings for venous leg ulcers

Background:

The efficacy of honey as a treatment for venous ulcers has not been evaluated, despite widespread interest. This trial aimed to evaluate the safety and effectiveness of honey as a dressing for venous ulcers.

Methods:

This community‐based open‐label randomized trial allocated people with a venous ulcer to calcium alginate dressings impregnated with manuka honey or usual care. All participants received compression bandaging. The primary outcome was the proportion of ulcers healed after 12 weeks. Secondary outcomes were: time to healing, change in ulcer area, incidence of infection, costs per healed ulcer, adverse events and quality of life. Analysis was by intention to treat.

Results:

Of 368 participants, 187 were randomized to honey and 181 to usual care. At 12 weeks, 104 ulcers (55·6 per cent) in the honey‐treated group and 90 (49·7 per cent) in the usual care group had healed (absolute increase 5·9 (95 per cent confidence interval (c.i.) ? 4·3 to 15·7) per cent; P = 0·258). Treatment with honey was probably more expensive and associated with more adverse events (relative risk 1·3 (95 per cent c.i. 1·1 to 1·6); P = 0·013). There were no significant differences between the groups for other outcomes.

Conclusion:

Honey‐impregnated dressings did not significantly improve venous ulcer healing at 12 weeks compared with usual care. Registration number: ISRCTN 06161544 ( http://www.controlled‐trials.com ). Copyright © 2008 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.     

A comparison of the in vitro moisture vapour transmission rate and in vivo fluid‐handling capacity of six adhesive foam dressings to a newly reformulated adhesive foam dressing

This study compared moisture vapour transmission rate (MVTR) and wear time or fluid‐handling capacities of six adhesive foam dressings to a reformulated control dressing. Standardised in vitro MVTR methodology and a previously published in vivo artificial wound model (AWM) were used. Mean inverted MVTR for the reformulated dressing was 12 750 g/m²/24 hours and was significantly higher than four of the six comparator dressings (P < 0·0001), which ranged from 830 to 11 360 g/m²/24 hours. Mean upright MVTR for the reformulated dressing was 980 g/m²/24 hours and was significantly different than all of the comparator dressings (P < 0·0001), which ranged from 80 to 1620 g/m²/24 hours (three higher/three lower). The reformulated dressing median wear time ranged from 6·1 to >7·0 days, compared with 1·0 to 3·5 days for the comparator dressings (P = 0·0012 to P < 0·0001). The median fluid volume handled ranged from 78·0 to >87 ml compared with 13·0 to 44·5 ml for the comparator dressings (P = 0·0007 to P < 0·001). Interestingly, inverted MVTR did not correspond well to the AWM. These results suggest that marked differences exist between the dressings in terms of both MVTR and wear time or fluid‐handling capacity. Furthermore, high inverted MVTR does not necessarily predict longer wear time or fluid‐handling capacities of absorbent dressings.     

A prospective,multicentre, randomised controlled study of human fibroblast‐derived dermal substitute (Dermagraft) in patients with venous leg ulcers

This was an open‐label, prospective, multicentre, randomised controlled study to evaluate the efficacy and safety of human fibroblast‐derived dermal substitute (HFDS) plus four‐layer compression therapy compared with compression therapy alone in the treatment of venous leg ulcers. The primary outcome variable was the proportion of patients with completely healed study ulcers by 12 weeks. The number healed was further summarised by ulcer duration and baseline ulcer size. Sixty‐four (34%) of 186 patients in the HFDS group experienced healing by week 12 compared with 56 (31%) of 180 patients in the control group (P = 0·235). For ulcers ≤ 12 months duration, 49 (52%) of 94 patients in the HFDS group versus 36 (37%) of 97 patients in the control group healed at 12 weeks (P = 0·029). For ulcers ≤ 10 cm², complete healing at week 12 was observed in 55 (47%) of 117 patients in the HFDS group compared with 47 (39%) of 120 patients in the control group (P = 0·223). The most common adverse events (AEs) were wound infection, cellulitis and skin ulcer. The frequency of AEs did not markedly differ between the treatment and control groups.     

Length of surgery and pressure ulcers risk in cardiovascular surgical patients: a dose–response meta‐analysis

The aim of this study was to assess the relationship between length of surgery (LOS) and pressure ulcer (PU) risk in cardiovascular surgery patients. PubMed and Web of Science were systematically searched. We compared LOS difference between PU (+) group and PU (‐) group. We also examined the dose–response effect of this relationship. The mean LOS in the PU(+) groups ranged from 252·5 to 335·7 minutes, compared with 233·0 to 298·3 minutes in PU(?) groups. The LOS was higher in PU(+) groups compared with PU(?) groups [weighted mean difference (WMD) = 36·081 minutes; 95% CI: 21·640–50·522 minutes; Z = 4·90, P = 0·000]. The funnel plot showed no publication bias. A significant dose–response association was also found between the LOS and the risk of surgery‐related pressure ulcers (SRPU, model χ² = 9·29, P = 0·000). In the linear model, the PU OR was 1·296 (95% CI 1·097–1·531) for a 60‐minute increase in the LOS intervals and 13·344 (95% CI 2·521–70·636) for a 600‐minute increase. In a spline model, the OR of PU increased almost linearly along with the LOS. Our meta‐analysis indicated that LOS was an important risk factor for pressure ulcers in cardiovascular surgical patients.     

Relationship between maceration and wound healing on diabetic foot ulcers in Indonesia: a prospective study

The aim of this study was to clarify the relationship between maceration and wound healing. A prospective longitudinal design was used in this study. The wound condition determined the type of dressings used and the dressing change frequency. A total of 62 participants with diabetic foot ulcers (70 wounds) were divided into two groups: non‐macerated (n = 52) and macerated wounds (n = 18). Each group was evaluated weekly using the Bates–Jensen Wound Assessment Tool, with follow‐ups until week 4. The Mann–Whitney U test showed that the changes in the wound area in week 1 were faster in the non‐macerated group than the macerated group (P = 0·02). The Pearson correlation analysis showed a moderate correlation between maceration and wound healing from enrolment until week 4 (P = 0·002). After week 4, the Kaplan–Meier analysis showed that the non‐macerated wounds healed significantly faster than the macerated wounds (log‐rank test = 19·378, P = 0·000). The Cox regression analysis confirmed that maceration was a significant and independent predictor of wound healing in this study (adjusted hazard ratio, 0·324; 95% CI, 0·131–0·799; P = 0·014). The results of this study demonstrated that there is a relationship between maceration and wound healing. Changes in the wound area can help predict the healing of wounds with maceration in clinical settings.     

A prospective, multi-centre, randomised, open label, parallel, comparative study to evaluate effects of AQUACEL® Ag and Urgotul® Silver dressing on healing of chronic venous leg ulcers

This study compared wound healing efficacy of two silver dressings, AQUACEL^® Ag and Urgotul^® Silver, against venous ulcers at risk of infection, over 8 weeks of treatment. The primary objective was to show non inferiority of AQUACEL^® Ag to Urgotul^® Silver. Patients (281) were randomised into two groups. The AQUACEL^® Ag group had 145 patients treated with AQUACEL^® Ag for 4 weeks followed by AQUACEL for another 4 weeks. TheUrgotul^® Silver group had 136 patients treated with Urgotul^® Silver for 4 weeks followed by Urgotul^® for another 4 weeks. In both groups, ulcer size and depth, safety events and ulcer healing were compared. After 8 weeks of treatment, the AQUACEL^® Ag group had a relative wound size reduction (49·65% ± 52·53%) compared with the Urgotul^® Silver group (42·81% ± 60·0%). The non inferiority of the AQUACEL^® Ag group to the Urgotul^® Silver group was established based on the difference between them (6·84% ± 56·3%, 95% confidence interval ?6·56 to 20·2) and the pre‐defined non inferiority margin (?15%). Composite wound healing analysis showed that the AQUACEL^® Ag group had statistically higher percentage of subjects with better wound progression (66·9% versus 51·9%, P = 0·0108). In general, both dressings were effective at promoting healing of venous ulcers.     

A comparative study to evaluate the effect of limited access dressing (LAD) on burn wound healing

Biochemical and histopathological analyses are commonly used objective parameters in research and clinical fields to assess the healing status of burn wounds. In this study, the effect of newer intermittent negative‐pressure wound therapy in combination with moist environment [limited access dressing (LAD)] on burn wound healing is studied. Various biochemical parameters like hydroxyproline, hexosamine and total protein, and antioxidants like reduced glutathione (GSH), glutathione peroxidase (GPx) and oxidative biomarker malondialdhyde (MDA) were measured in the granulation tissue. Histopathologically, necrotic tissue, amount of inflammatory infiltrate, angiogenesis and extracellular matrix deposition (ECM) were studied to determine wound healing. A total of 55 patients were divided into two groups as follows: LAD group (n = 28) and conventional dressing group (n = 27). Patients treated with LAD have shown significant increase in the mean levels of (±SD) hydroxyproline (75·2 ± 26·30 versus 27·8 ± 15·5; P = 0·010), hexosamine (9·0 ± 1·99 versus 8·0 ± 1·18; P = 0·038), total protein (15·6 ± 8·23 versus 10·26 ± 4·94; P = 0·003), GSH (7·40 ± 1·91 versus 5·1 ± 1·28; P = 0·037), GPx (112·6 ± 46·4 versus 92 ± 32·4; P = 0·016), and decrease in MDA (6·5 ± 2·24 versus 1 0·6 ± 3·8; P = 0·002). Histopathologically, between LAD and conventional dressing groups, there was a significant difference after 10 days of treatment (mean±SE) in necrotic tissue of (LAD versus conventional dressing groups = 10 ± 1·8 versus 11·9 ± 2·6; P = 0·033), inflammatory cells (8·4 ± 1·9 versus 13 ± 3·46; P = 0·021), new blood vessels (12·5 ± 2·87 versus 9·4 ± 1·7; P = 0·047), ECM deposit (12·9 ± 2·41 versus 9·68 ± 1·3; P = 0·018) and showed comparatively fewer inflammatory cells, increased and well‐organised extracellular matrix deposit, more angiogenesis in LAD group as compared with that in conventional dressing group. To conclude, LAD exerts its beneficial effects on wound healing by reducing oxidative stress, decreasing necrotic tissue and amount of inflammatory infiltrate, and increasing ECM deposition and angiogenesis.     

Perioperative corticosteroids administration as a risk factor for pressure ulcers in cardiovascular surgical patients: a retrospective study

The aim of this study was to investigate the relationship between perioperative corticosteroids administration and the incidence of pressure ulcers (PUs) in cardiovascular surgical patients. A retrospective analysis was performed on data from consecutive patients who had cardiac surgery in 2012. Univariate and multivariate logistic regression analyses were performed to evaluate the relationship between perioperative corticosteroid administration and the incidence of surgery‐related PU (SRPU). A total of 286 cardiac surgery patients were included in this study; of these, 47 patients developed 57 SRPUs, an incidence of 16·4% [95% confidence interval (CI): 12·3–21·2%). The SRPU incidence was significantly higher in corticosteroid‐administered group compared with groups not receiving corticosteroids (43·8% versus 14·8%, Pearson's χ² = 9·209, P = 0·002). The crude odds ratio (OR) was 4·472 (95% CI: 1·576–12·694). After performing multivariate logistic regression analysis, the adjusted OR was 2·808 (95% CI: 1·062–11·769). This result showed that perioperative corticosteroid administration was an independent risk factor for PUs in cardiovascular surgical patients. Therefore, it is recommended that in order to prevent PU perioperative corticosteroids should be administered with caution to cardiovascular surgical patients.     

A parallel open-label trial to evaluate microbial cellulose wound dressing in the treatment of diabetic foot ulcers

The purpose of this study was to compare the rate of wound healing in diabetic foot ulcers (DFU) using either a microbial cellulose (MC) wound dressing or Xeroform? Petrolatum gauze. In a parallel, open‐label trial in which the primary outcome was the rate of wound healing and the time to wound closure, 15 ulcers in type II diabetic patients received an MC dressing. Wounds in 19 control patients with type II diabetes were treated with a Xeroform gauze dressing. All wounds were non infected, Wagner stage II or III and received standard care including debridement, non weight bearing limb support and weekly wound evaluation. The mean time to heal in the MC (±SE) treated group was 32 days ± 2·5 and for controls it was 48 days ± 4·7 (P < 0·01). The rate of weekly wound closure (mean ± SE) was 1·7 times faster in the MC‐treated group (cellulose treated, ?5·04% per week ± 0·38 versus control, ?2·93% per week ± 0·19), (P < 0·001). Among covariants tested by univariate regression, only the original wound area correlated with the time to wound closure (P < 0·001). In conclusion, with the provision of current standards of care, the application of an MC dressing to a diabetic ulcer may enhance the rate of wound healing and shorten the time course of epithelisation.     

Clinical evaluation of gauze‐based negative pressure wound therapy in challenging wounds

The aim of this randomised clinical study was to evaluate the effectiveness and safety of gauze‐based negative pressure wound therapy (NPWT) in patients with challenging wounds. A total of 50 consecutive patients who had wound drainage for more than 5 days, required open wound management and had existence of culture positive infection were included the study. In this study, gauze‐based NPWT was compared with conventional dressing therapy in the treatment of patients with difficult‐to‐heal wounds. The patients were randomly divided into two groups. Group I (n = 25) was followed by conventional antiseptic (polyhexanide solution) dressings, and group II (n = 25) was treated with saline‐soaked antibacterial gauze‐based NPWT. The wounds' sizes, number of debridement, bacteriology and recurrence were compared between group I and group II. The mean age of the patients was 59·50 years (range 23–97). In group I, average wound sizes of pre‐ and post‐treatment periods were 50·60 ± 55·35 and 42·50 ± 47·92 cm², respectively (P < 0·001). Average duration of treatment was 25·52 ± 16·99 days, and average wound size reduction following the treatment was 19·99% in this group. In group II, the wounds displayed considerable shrinkage, accelerated granulation tissue formation, decreased and cleared away exudate. The average wound sizes in the pre‐ and post‐treatment periods were 98·44 ± 100·88 and 72·08 ± 75·78 cm², respectively (P < 0·001). Average duration of treatment was 11·96 ± 2·48 days, and average wound size reduction following the treatment was 32·34%. The patients treated with antibacterial gauze‐based NPWT had a significantly reduced recurrence (2 wounds versus 14 wounds, P = 0·001), and increased number of the culture‐negative cases (22 wounds versus 16 wounds, P < 0·047) in a follow‐up period of 12 months. There was a statistically significant difference between two groups in all measurements. As a result, we can say that the gauze‐based NPWT is a safe and effective method in the treatment of challenging infective wounds when compared with conventional wound management.     

IPARZINE‐SKR study: randomized,double‐blind clinical trial of a new topical product versus placebo to prevent pressure ulcers

This study compared the efficacy of a new topical agent (IPARZINE‐4A‐SKR) on preventing category I pressure ulcers (PUs) over a 2‐week period, compared with a placebo. A double‐blind, randomised, multi‐centre, placebo‐controlled clinical trial in two parallel groups was conducted. The primary objective was to compare PU incidence between groups. Hospital and socio‐sanitary centre patients (n = 194) at risk of developing a PU (Braden scale) were randomised into two groups. The intervention group included 99 patients, and the placebo group comprised 95 patients. Patients were comparable in terms of age, sex and PU risk. In both groups, patients had a high risk of developing PUs. The product was applied on the sacrum, trochanters and heels. Six PUs (incidence = 6·1%) were detected in the intervention group versus seven (incidence = 7·4%) in the placebo group. Differences were not statistically significant (z = 0·08; P = 0·94), relative risk = 0·82 (95% confidence interval = 0·29–2·36). The main limitation of the study was the sample size and, therefore, the main difficulty encountered was in determining whether the product is ineffective or simply has not been used with sufficient patients. In conclusion, it is not possible to confirm that there are any differences between the studied and the placebo treatments in the prevention of PUs. The results obtained were similar to those obtained in studies of PU prevention using products based on topical fatty acids.     

The efficacy of removable devices to offload and heal neuropathic plantar forefoot ulcers in people with diabetes: a single‐blinded multicentre randomised controlled trial

Non‐removable offloading is the ‘gold standard’ treatment for neuropathic diabetic plantar forefoot ulcers. However, removable offloading is the common ‘standard of care’. We compared three removable offloading devices for ulcer healing efficacy. In this multicentre, randomised controlled trial, 60 persons with neuropathic diabetic plantar forefoot ulcers were randomly assigned to wear a custom‐made knee‐high cast [BTCC (bivalved TCC)], custom‐made ankle‐high cast shoe or a prefabricated ankle‐high forefoot‐offloading shoe (FOS). Primary outcome was healing at 12 weeks. Dynamic plantar pressures, daily stride count and treatment adherence were assessed on a randomly selected subset (n = 35). According to intention‐to‐treat analysis, 58% of patients healed with BTCC [OR 0·77 (95% CI 0·41–1·45) versus FOS], 60% with cast shoe [OR 0·81 (95% CI 0·44–1·49) versus FOS] and 70% with FOS (P = 0·70). Mean ± SD peak pressure in kPa at the ulcer site was 81 ± 55 for BTCC, 176 ± 80 for cast shoe and 107 ± 52 for FOS (P = 0·005); stride count was 4150 ± 1626, 3514 ± 1380 and 4447 ± 3190, respectively (P = 0·71); percentage of 2‐week intervals that patients wore the device <50% of time was 17·3%, 5·2% and 4·9%, respectively. Non‐significant differences in healing efficacy between the three devices suggest that, when non‐removable offloading is contraindicated or not available, each can be used for plantar forefoot ulcer offloading. Efficacy is lower than previously found for non‐removable offloading maybe because suboptimal adherence and high stride count expose the patient to high repetitive stresses. These factors should be carefully considered in decision making regarding ulcer treatment.