Effectiveness of collagen/oxidised regenerated cellulose/silver‐containing composite wound dressing for the treatment of medium‐depth split‐thickness skin graft donor site wounds in multi‐morbid patients: a prospective,non‐comparative,single‐centre study

Split‐thickness skin grafting (STSG) is a widely used method in reconstructive surgery, but donor site wounds (DSWs) are often slow healing and painful. This prospective study evaluated the performance of a composite wound dressing containing collagen/oxidised regenerated cellulose in the treatment of medium‐depth (0·4 mm) DSWs in 25 multi‐morbid patients with chronic leg ulcers requiring STSG. The range of patients' ages was 44–84 years (mean 71·6 years) with DSW sizes ranging between 12 and 162 cm² (mean 78 cm²). Comorbidities included anticoagulation therapy (15 patients), anaemia (11 patients), diabetes (6 patients) and methicillin‐resistant Staphylococcus aureus (MRSA) ulcer colonisation (6 patients). The first dressing change was performed after 10 days. Complete reepithelialisation was observed between the 10th and 34th day (mean 17·2, median 14 days). Postoperative medium to strong bleeding occurred in only five patients (four with anticoagulation). Wound pain levels one day after harvesting were only moderate (range 0–1·5, mean 0·5, median 0·5 on a six‐item scale). No wound infection was observed during the first dressing. The composite dressing used allowed for the fast healing of medium‐depth DSWs with minimal or no postoperative pain and bleeding in older multi‐morbid patients under anticoagulation treatment.     

The use of Urgotul™ in the treatment of partial thickness burns and split‐thickness skin graft donor sites: a prospective control study

The use of paraffin‐impregnated gauze for burns and skin graft donor sites is commonly associated with wound adherence with consequent pain and trauma upon removal. This prospective clinical study was performed to evaluate a new class of lipido‐colloid dressings (Urgotul^?) in promoting healing and in reducing tissue adherence. In a 6‐month period, 25 consecutive patients were recruited. Two separate burn or donor sites on each patient were dressed with tulle‐gras (TG) or Urgotul^? and covered with standard secondary dressings. Objective assessment of wounds by two reviewers, and patients' subjective assessments were recorded. Twenty‐three (92%) patients were followed up for a mean of 3 months. Mean time to complete epithelialisation was 9·6 and 11·9 days for the Urgotul^? and TG sites respectively (P < 0·05). Bleeding was seen in 52% of Urgotul^? sites compared with 100% of the TG sites at first dressing change (P < 0·05). Patients reported ‘moderate pain’ during dressing change in 22% and 57% in the Urgotul^? and TG groups respectively (P < 0·05), with 35% of TG sites being ‘very painful’ requiring extra analgesia. We found that compared with TG, Urgotul^? was associated with faster epithelialisation, less pain and trauma (bleeding) during dressing changes.     

Safety and performance evaluation of a next‐generation antimicrobial dressing in patients with chronic venous leg ulcers

The objective of this study was to investigate the safety and performance of AQUACEL? Ag+ dressing, a wound dressing containing a combination of anti‐biofilm and antimicrobial agents, in the management of chronic wounds. Patients (n = 42) with venous leg ulcers exhibiting signs of clinical infection were treated for 4 weeks with AQUACEL? Ag+ dressing, followed by management with AQUACEL? wound dressings for 4 weeks. Wound progression, wound size, ulcer pain and clinical evolution of the wound were assessed for up to 8 weeks. Adverse events were recorded throughout the study. AQUACEL? Ag+ dressing had an acceptable safety profile, with only one patient discontinuing from the study, because of a non‐treatment‐related adverse event. After 8 weeks, substantial wound improvements were observed: 5 patients (11·9%) had healed ulcers and 32 patients (76·2%) showed improvement in ulcer condition. The mean ulcer size had reduced by 54·5%. Patients reported less pain as the study progressed. Notable improvements were observed in patients with ulcers that were considered to require treatment with systemic antibiotics or topical antimicrobials at baseline (n = 10), with a mean 70·2% reduction in wound area. These data indicate that AQUACEL? Ag+ dressing has an acceptable safety profile in the management of venous leg ulcers that may be impeded by biofilm.     

Comparison of the efficacy and safety of povidone‐iodine foam dressing (Betafoam), hydrocellular foam dressing (Allevyn), and petrolatum gauze for split‐thickness skin graft donor site dressing

We evaluated the efficacy and safety of a povidone‐iodine (PVP‐I) foam dressing (Betafoam) for donor site dressing versus a hydrocellular foam dressing (Allevyn) and petrolatum gauze. This prospective Phase 4 study was conducted between March 2016 and April 2017 at eight sites in Korea. A total of 106 consenting patients (aged ≥ 19 years, scheduled for split‐thickness skin graft) were randomised 1:1:1 to PVP‐I foam, hydrocellular, or petrolatum gauze dressings for up to 28 days after donor site collection. We assessed time to complete epithelialisation, proportion with complete epithelialisation at Day 14, and wound infection. Epithelialisation time was the shortest with PVP‐I foam dressing (12.74 ± 3.51 days) versus hydrocellular foam dressing (16.61 ± 4.45 days; P = 0.0003) and petrolatum gauze (15.06 ± 4.26 days, P = 0.0205). At Day 14, 83.87% of PVP‐I foam dressing donor sites had complete epithelialisation, versus 36.36% of hydrocellular foam dressing donor sites (P = 0.0001) and 55.88% of petrolatum gauze donor sites (P = 0.0146). There were no wound infections. Incidence rates of adverse events were comparable across groups (P = 0.1940). PVP‐I foam dressing required less time to complete epithelialisation and had a good safety profile.     

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.     

An evaluation of five different dressing materials on split‐thickness skin graft donor site and full‐thickness cutaneous wounds: an experimental study

The objective of this study was to investigate the healing effect of five different products on split‐thickness skin graft (STSG) donor sites and full‐thickness cutaneous wounds (FTCWs) using an occlusive dressing model. Six groups were included: 1 control and 5 experimental groups, with a total of 24 rats, using an occlusive dressing model. STSG donor sites and FTCWs were established in two separate areas, to the right and left on the animals' backs. Wound sites were dressed with one of the following materials: fine mesh gauze, microporous polysaccharide hemosphere (MPH), clinoptilolite, alginate, hydrogel or biosynthetic wound dressing (Biobran^®). These materials were compared in terms of healing rate, healing quality and histopathological findings. Occlusive dressings were applied to each wound on days 0, 3, 5, 7, 10 and 14. Area measurements were taken using images of each dressing. The alginate and clinoptilolite groups gave the best healing rate results for both STSG donor sites (P = 0·003) and FTCWs (P = 0·003). MPH came third in each group. The alginate group produced better results in terms of healing quality criteria, followed by hydrogel, MPH, clinoptilolite and Biobran^®, in that order. Statistically significant results were obtained in all groups compared to the control group (P < 0·0007). Rapid and good healing quality for both the STSG donor sites and FTCWs were obtained with alginate. Healing with clinoptilolite and MPH was rapid, but poor quality, while slower but good healing quality was obtained with hydrogel. Slower and worse quality healing was obtained with Biobran^®.     

Clinical efficacy of a silver‐releasing foam dressing in venous leg ulcer healing: a randomised controlled trial

Biatain and Biatain‐Ag are two identical wound dressings except the fact that Biatain‐Ag releases silver. In the present multinational double‐blinded randomised controlled trial the effect of the two dressings were compared for treatment of venous leg ulcers. A total of 181 patients were treated for 6 weeks with either Biatain or Biatain‐Ag followed by 4 weeks treatment with Biatain. Biatain‐Ag showed superior performance in relative wound area reduction after 6 weeks treatment and the estimated treatment difference increased after 10 weeks indicating that the effect of silver continues at least for 4 weeks after treatment. A subgroup of the patients differed significantly from the others with respect to parameters associated with a poor healing prognosis; patients were older, had significant history of venous thrombosis, larger ulcers with longer duration and more often recurrent. For this subgroup of patients Biatain‐Ag showed significant (P < 0·05) better performance in terms of relative ulcer area reduction and healing rate. In conclusion, this study suggests the superior performance of Biatain‐Ag compared with the non silver‐releasing dressing Biatain in particular for patients having ulcers associated with a poor healing prognosis.     

Aquacel Ag dressing versus Acticoat™ dressing in partial thickness burns: A prospective,randomized, controlled study in 100 patients. Part 1: Burn wound healing

Introduction

Studies comparing contemporary silver dressings in burns are scarce.

Methods

In a prospective, randomized, controlled study, counting 50 patients/research group, we compared two frequently used silver dressings, Acticoat™ and Aquacel^® Ag, in the management of partial thickness burns with a predicted healing time between 7 and 21 days as assessed by laser Doppler imaging between 48 and 72 h after burn. Variables investigated were related to baseline research group characteristics, wound healing, bacteriology, economics, nurse, and patient experience.

Results

Both research groups were comparably composed taking into account gender, age and burn characteristics. Similar results were obtained as to healing time and bacterial control with both silver dressings. A statistically significant difference in favor of the Aquacel^® Ag dressing was found for average ease of use (p < 0.001), average ease of application (p = 0.001), patient pain (p < 0.001), patient comfort with the dressing (p = 0.017), silver staining (p < 0.001), and cost effectiveness (p < 0.001).

Conclusion

Both silver dressings resulted in comparable healing times and bacterial control but the Aquacel^® Ag dressing significantly increased comfort for patients as well as nurses and was significantly more cost-effective than the Acticoat™ dressing for the given indication.     

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.     

Efficacy and cost‐effectiveness of octenidine wound gel in the treatment of chronic venous leg ulcers in comparison to modern wound dressings

The aim of this study was to determine the efficacy, safety and cost‐effectiveness of an octenidine‐based wound gel in the treatment of chronic venous leg ulcers. For this purpose, 49 wounds were treated with either modern wound‐phase‐adapted dressings alone (treatment arm 1; n = 17), octenidine wound gel plus modern wound‐phase‐adapted dressings (treatment arm 2; n = 17) or octenidine wound gel alone (treatment arm 3; n = 15). During the study period of 42 days with dressing changes every 3–5 days, wound healing characteristics and treatment costs of different dressings were analysed. Wound size reduction was significantly better (P = 0·028) in both octenidine wound gel treatment arms compared to modern dressings alone with total reductions of 14·6%, 64·1% and 96·2% in treatment arms 1–3. Early wound healing was merely observed under octenidine wound gel treatment (n = 9), whereby lowest treatment costs were generated by octenidine wound gel alone (€20·34/dressing change). As a result, the octenidine wound gel is cost‐effective and well suitable for the treatment of chronic venous leg ulcers, considering both safety and promotion of wound healing.     

A prospective,randomized trial of silver containing hydrofiber dressing versus 1% silver sulfadiazine for the treatment of partial thickness burns

Silver sulfadiazine has been used as a topical burn wound treatment for many years. Pain associated with dressing changes is a common problem in burn wounds. Aquacel Ag, a hydrofiber dressing coated with ionic silver has been reported to reduce burn wound infection and promote antimicrobial activity. The purpose of this study was to show the benefits of Aquacel Ag for the treatment of partial thickness burns. This prospective randomized study was conducted in 70 patients who had partial thickness burns less than 15% of total body surface area and were treated at Siriraj outpatient burn clinic during December 2006–February 2008. Patients were divided into two groups: Aquacel Ag‐treated group with dressing changes every 3 days (35 patients) and 1% silver sulfadiazine‐treated group, with daily dressing changes (35 patients). There was no difference in demographic data including age, gender, burn percentage between groups. Time‐to‐wound healing pain score during dressing change and cost of treatment were compared between both groups. Time‐to‐wound closure was significantly shorter in the Aquacel Ag‐treated group (10 ± 3 versus 13.7 ± 4 days, P < 0·02) as well as pain scores at days 1, 3 and 7 (4·1 ± 2·1, 2·1 ± 1·8, 0·9 ± 1·4 versus 6·1 ± 2·3, 5·2 ± 2·1, 3·3 ± 1·9, respectively, P < 0·02). Total cost of treatment was 52 ± 29 US dollars for the Aquacel Ag‐treated group versus 93 ± 36 US dollars for the silver sulfadiazine‐treated group. This study showed that Aquacel Ag increased time to healing, decreased pain symptoms and increased patient convenience because of limiting the frequency of replacement of the dressing at lower total cost. This study confirms the efficacy of Aquacel Ag for the treatment of partial thickness burns at an outpatient clinic.     

Calcium alginate dressing accelerates split skin graft donor site healing

A prospective controlled trial of calcium alginate compared with traditional dressing of paraffin gauze on split skin graft (SSG) donor sites had to be abandoned after 15 patients as there was consistently better healing under the calcium alginate. The study was continued, on every patient requiring split skin grafting, to assess calcium alginate from the point of view of patient comfort, ease of dressing and quality of regenerated skin. In 107 patients with 130 SSG donor operations, there was a statistically highly significant decrease in average time to complete healing (from 10 down to 7 days), and also significantly better patient comfort. The alginate dressings were easy to use and the quality of the new skin significantly better than that seen under paraffin gauze dressings.     

Split-thickness skin graft donor site management: a randomized controlled trial comparing polyurethane with calcium alginate dressings

Split‐thickness skin grafting (SSG) is a common reconstructive technique for the treatment of patients with deep burns and other traumatic injuries. The management of the donor site after harvesting an SSG remains controversial because of a variety of dressings available for use. The aim of this randomized controlled trial was to compare the effectiveness of a polyurethane dressing, Allevyn?, to a calcium alginate, Kaltostat®. From August 2009 to April 2010, 36 patients were randomized to Allevyn? or Kaltostat® for donor site management following split skin graft surgery. Pain intensity and adverse events were the primary outcomes assessed. Secondary outcome measures included time for wound healing, ease of application and removal and overall patient satisfaction. Time to first dressing change was earlier in those randomized to Allevyn? compared with Kaltostat® (5·5 days versus 8·11 days, P = 0·014). In patients randomized to Allevyn?, excessive exudate lead to a significantly increased number of dressing changes before day 10 (14 days versus 7 days, P = 0·018). The total number of dressing changes applied was also greater in those with Allevyn? compared with Kaltstat® (P = 0·007). There were no significant differences between the two treatment groups with respect to time to wound healing, level of pain intensity, length of stay, staff and patient satisfaction levels. This trial showed Allevyn? to be associated with increase demands on nursing time, increased cost of dressing products, medical consumables and wastes. Kaltostat® remains the dressing of choice for initial donor site dressing in this burns unit.     

Impact of gauze‐based NPWT on the patient and nursing experience in the treatment of challenging wounds

Negative pressure wound therapy is widely used in the treatment of hard‐to‐heal wounds; however, pain during dressing changes, which is often associated with pain on the commencement and cessation of pressure application and because of in‐growth of new granulation tissue into interstices of foam dressings, is often experienced. Anecdotal reports have suggested that choice of gauze as the negative pressure wound therapy dressing may reduce the pain associated with dressing changes. A prospective, multi‐center, non‐comparative clinical investigation was carried out using gauze‐based negative pressure wound therapy in chronic and acute wounds. Over 152 patients were evaluated. Median duration of therapy was 18 days with 91% of patients progressing towards healing at the end of therapy. Wound pain and odour were significantly reduced (P < 0·001) over the course of therapy. Wound pain during dressing changes was reported to be absent in 80% of dressing removals. No damage to the wound bed following dressing removal was observed in 96% of dressing changes. Dressing applications were considered easy in 79% of assessments and took a median of 20 min to complete. In patients susceptible to pain, gauze‐based negative pressure therapy may be a viable option to maximise patient comfort.     

Custom-fit polymeric membrane dressing masks in the treatment of second degree facial burns

Second degree facial burns usually impart high wound site pain levels and patient discomfort due to the abundance of facial sensory innervation, as well as the development of edema and inflammation that accompany wound healing. Frequent changing of adherent dressings causes additional procedural pain and may prolong healing due to recurring damage to the wound bed. We applied face masks, made on-site from a drug free polymeric membrane dressing, to 8 patients with superficial and deep 2nd degree facial burns. Time to full re-epithlialization was recorded during treatment. Pain, overall comfort, and result satisfaction were evaluated using a questionnaire (10-point Likert scales. From 1 = minimum to 10 = maximum) on follow-up (mean follow up 14.4 months, range 9–18). These results were compared to a historical cohort of patients with facial burns that were treated with an antibiotic ointment. Results showed mean re-epithelialization time of 6.5 days (as compared to 8.5 days in the cohort group), low pain ratings (mean: 2.6; range: 4.7 in the control group), mixed comfort levels (mean: 4.7/10; 4 in the control group) and high result satisfaction (mean: 7.8; 6.2 in the control group). Nursing staff described pain-free dressing changes and positively noted non-adherence and high absorbance capacity of the polymer, necessitating less dressing changes. Inflammation was contained to the actual site of injury. No complications in terms of infection or allergic reaction were observed. Overall, the polymeric membrane facial dressing seems to be a promising means of reducing pain and ensuring uninterrupted wound healing in 2nd degree facial burns.     

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.     

Human Amniotic Membrane: A New Option for Graft Donor Sites – Systematic Review and Meta‐analysis

There are currently no standardised guidelines on the optimum dressing used for graft donor sites. The aim was to compare the outcomes of human amniotic membrane (HAM) vs routine dressings in split‐thickness skin graft (STSG) donor site healing. A systematic review and meta‐analysis was performed and a search of electronic information was conducted to identify all randomised controlled trials comparing the outcomes of HAM vs routine dressings in STSG donor sites. Wound healing and infection rate were primary outcome measures. Secondary outcome measures included severity of pain, discharge from donor site, the number of dressing changes, pruritus, and comfort. Fixed effect modelling was used for the analysis. Four studies enrolling 157 patients were identified. There was a significant difference between HAM and routine groups with wound healing time (P < .0001) and proportion of wounds healed by day 12 (P = .01). There was no significant difference between the two groups in infection rates (P = .27). For all secondary outcomes, HAM had improved results. HAM dressings are a superior option when compared with routine dressings used in current clinical practice for STSG donor sites as they improve wound healing and do not increase the infection rate.     

Efficacy of a povidone‐iodine foam dressing (Betafoam) on diabetic foot ulcer

This study aimed to assess the efficacy of a new povidone‐iodine (PVP‐I) foam dressing (Betafoam) vs foam dressing (Medifoam) for the management of diabetic foot ulcers. This study was conducted between March 2016 and September 2017 at 10 sites in Korea. A total of 71 patients (aged ≥19 years) with type 1/2 diabetes and early‐phase diabetic foot ulcers (Wagener classification grade 1/2) were randomised to treatment with PVP‐I foam dressing or foam dressing for 8 weeks. Wound healing, wound infection, patient satisfaction, and adverse events (AEs) were assessed. The PVP‐I foam and foam dressing groups were comparable in the proportion of patients with complete wound healing within 8 weeks (44.4% vs 42.3%, P = .9191), mean (±SD) number of days to complete healing (31.00 ± 15.07 vs 33.27 ± 12.60 days; P = .6541), and infection rates (11.1% vs 11.4%; P = 1.0000). Median satisfaction score (scored from 0 to 10) at the final visit was also comparable between groups (10 vs 9, P = .2889). There was no significant difference in AE incidence (27.8% vs 17.1%, P = .2836), and none of the reported AEs had a causal relationship with the dressings. The results of this study suggest that PVP‐I foam dressing has wound‐healing efficacy comparable with foam dressing, with no notable safety concerns. This study was funded by Mundipharma Korea Ltd and registered at ClinicalTrials.gov (identifier NCT02732886).