A factorial, randomized trial of pentoxifylline or placebo, four-layer or single-layer compression, and knitted viscose or hydrocolloid dressings for venous ulcers

OBJECTIVES: We evaluated the effectiveness of pentoxifylline, knitted viscose or hydrocolloid dressings, and single-layer or four-layer bandaging for venous ulceration. METHOD: A factorial randomized controlled trial with 24-week follow-up was conducted in leg ulcer clinics in Scotland with blinded allocation to pentoxifylline (1200 mg) or placebo, knitted viscose or hydrocolloid dressings, and single-layer or four-layer bandages. The study enrolled 245 adults with venous ulcers. The main outcome measure was time to complete healing. Secondary outcomes included proportions healed, withdrawals, and adverse events. Analysis was by intention to treat. RESULTS: There was no evidence of interaction between the drug, bandages, and dressings. Pentoxifylline was associated with nonsignificant increased ulcer healing (62% vs 53%; P = .21). Four-layer bandages were associated with significantly higher healing rates (67% vs 49%; P = .009). There was no difference in healing between knitted viscose and hydrocolloid dressings (58% and 57%; P = .88). Cox regression models increased the significance of the pentoxifylline effect (relative risk of healing, 1.4; 95% confidence interval, 1.0 to 2.0). CONCLUSIONS: Pentoxifylline increased the proportion healing compared with placebo to the same extent as shown in recent systematic reviews, although this finding was only statistically significant when a secondary adjusted analysis was conducted. Four-layer bandaging produced higher healing rates than single-layer bandaging. There was no difference in time to healing between knitted viscose and hydrocolloid dressings.     

Prospective,randomized, multicenter study evaluating safety and efficacy of intragastric dual-balloon in obesity

BackgroundIntragastric balloons are designed to occupy space within the stomach and induce satiety. The present study evaluated the safety and efficacy of an intragastric dual balloon as an adjunct to diet and exercise in obese patients compared with diet and exercise alone.MethodsAfter approval from the institutional review board, patients provided written consent and were randomized to the treatment group (TG) or control group (CG) in a 2:1 ratio. Three sites randomized a total of 30 patients to the TG (n = 21) or CG (n = 9). Patients randomized to the TG underwent endoscopic placement of the dual balloon. Both groups received similar diet and exercise counseling. After 24 weeks, the device was removed. Patient weight, adverse events, and quality of life data were evaluated throughout the 48-week study duration.ResultsOur patient population included 26 women and 4 men aged 26–59 years. At 24 weeks, the mean excess weight loss in the TG and CG was 31.8% ± 21.3% and 18.3% ± 20.9%, respectively (P = .1371). At 48 weeks, 24 weeks after device removal, the TG maintained 64% of their weight loss. No deaths, unanticipated adverse effects, early removals, balloon deflations, or balloon migrations occurred. In the TG, 4 patients were readmitted for severe nausea, 1 had asymptomatic gastritis at balloon removal, and 1 patient experienced transient hypoxia during device removal.ConclusionIn the present small study, the dual balloon proved easy to use, was associated with a trend toward greater weight loss than the CG, and demonstrated a good safety profile.     

Diagnosis and management of pressure ulcers

Pressure ulcers represent a significant health issue and cost for the growing number of elderly and debilitated patients. The plastic surgeon, as part of the wound care team, has the ultimate responsibility of forming a plan to allow for the eventual closure of the wound. This plan should start with breaking the cycle and eliminating the risk factors that led to the development of the wound. Simultaneously, the surgeon should order an MRI and erythrocyte sedimentation rate and take a bone biopsy to diagnose the extent of the wound and the bacteria present. If more than 10(5) bacteria are present, surgical debridement should be performed, followed by 6 weeks of intravenous antibiotics. Once the bacterial load has been lessened, a 6-week course of Regranex should be applied. Finally, after the wound bed has been prepared adequately, definitive surgical closure should be planned and performed.     

Negative pressure and nanocrystalline silver dressings for nonhealing ulcer: A randomized pilot study

Chronic wounds have a high prevalence and wound care, treatment, and prevention consume large quantities of resources. Chronic wounds are a growing challenge for clinicians. A prospective randomized pilot study was conducted to assess the effectiveness in terms of reduction in area and safety of the combined use of negative‐pressure wound therapy and nanocrystalline silver dressings as compared to negative pressure wound therapy (NPWT) alone in the management of outpatients with chronic wounds. A total of 17 patients were included in the study, 10 were treated with the combined method and 7 with NPWT. Patients were followed for 6 weeks, with a final assessment at 3 months. Clinical improvement, microbiologic data, and toxicity of silver were evaluated. The antibacterial effects of ionic silver together with the development of granulation tissue promoted by NPWT reduced significantly the median extension of the wound between weeks 3 and 6 of treatment. The combination with silver also reduced bacterial colonization with Pseudomonas aeruginosa and the bacterial load on the surface of the wound. The silver levels correlated positively with the extension of the wound, although in none of the patients’ toxic levels were reached. The combination of NPWT with nanocrystalline silver dressings was safe and as effective as NPWT alone.     

Systematic review of the use of prophylactic dressings in the prevention of pressure ulcers

This systematic review considers the evidence supporting the use of prophylactic dressings for the prevention of pressure ulcer. Electronic database searches were conducted on 25 July 2013. The searches found 3026 titles and after removal of duplicate records 2819 titles were scanned against the inclusion and exclusion criteria. Of these, 2777 were excluded based on their title and abstract primarily because they discussed pressure ulcer healing, the prevention and treatment of other chronic and acute wounds or where the intervention was not a prophylactic dressing (e.g. underpads, heel protectors and cushions). Finally, the full text of 42 papers were retrieved. When these 42 papers were reviewed, 21 were excluded and 21 were included in the review. The single high‐quality randomised controlled trial (RCT) and the growing number of cohort, weak RCT and case series all suggest that the introduction of a dressing as part of pressure ulcer prevention may help reduce pressure ulcer incidence associated with medical devices especially in immobile intensive care unit patients. There is no firm clinical evidence at this time to suggest that one dressing type is more effective than other dressings.     

Prospective clinical study of a new adhesive gelling foam dressing in pressure ulcers

This prospective, non comparative study evaluated the safety and effectiveness of an adhesive gelling foam dressing in pressure ulcer management. Twenty-three subjects with exuding pressure ulcers were recruited from seven centres in the USA and Canada. Study treatment included an adhesive gelling foam dressing, optional tape/roll bandaging and mandatory pressure-reducing/relieving devices. Subjects were followed until ulcer healing, for up to 28 days, or on patient withdrawal from the study, whichever came first. Dressings were changed at least once every 7 days. Mean percentage change in ulcer area from baseline to final measurement was -13%. Investigators reported healing or subjective improvement of ulcer condition in 61% of patients. Mean dressing wear time was 4.2 days. Subjects found the dressing was comfortable, soothing and cushioning in situ at 80%, 64% and 70% of dressing changes, respectively. Subjects reported pain severity of none or mild for every dressing change. Fourteen subjects experienced adverse events, including seven subjects with study-related maceration, erythema, wound enlargement, blister or infection. A regimen including an adhesive gelling foam dressing proved to be safe and effective for managing exudate, protecting the surrounding skin, minimising pain and supporting healing of pressure ulcers with exudate.     

Becaplermin gel in the treatment of pressure ulcers: a phase II randomized, double-blind, placebo-controlled study

Pressure ulcers are associated with significant rates of morbidity and mortality, particularly in the geriatric and spinal cord-injured populations. Newer pharmacologically active therapies include the use of topically applied recombinant human platelet-derived growth factor-BB (becaplermin), the active ingredient in REGRANEX) (becaplermin) Gel 0.01%, which has been approved in the United States for treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. In this study, the efficacy of becaplermin gel in the treatment of chronic full thickness pressure ulcers was compared with that of placebo gel. A total of 124 adults (>/= 18 years of age) with pressure ulcers were assigned randomly to receive topical treatment with becaplermin gel 100 microg/g (n = 31) or 300 microg/g (n = 32) once daily alternated with placebo gel every 12 hours, becaplermin gel 100 microg/g twice daily (n = 30), or placebo (sodium carboxymethylcellulose) gel (n = 31) twice daily until complete healing was achieved or for 16 weeks. All treatment groups received a standardized regimen of good wound care throughout the study period. Study endpoints were the incidence of complete healing, the incidence of >/= 90% healing, and the relative ulcer volume at endpoint (endpoint/baseline). Once-daily treatment of chronic pressure ulcers with becaplermin gel 100 microg/g or 300 microg/g significantly increased the incidences of complete and >/= 90% healing and significantly reduced the median relative ulcer volume at endpoint compared with that of placebo gel (p < 0.025 for all comparisons). Becaplermin gel 300 microg/g did not result in a significantly greater incidence of healing than that observed with 100 microg/g. Treatment with becaplermin gel was generally well tolerated and the incidence of adverse events was similar among treatment groups. In conclusion, once-daily application of becaplermin gel is efficacious in the treatment of chronic full thickness pressure ulcers.     

Surgical and reconstructive management of pressure ulcers

Despite significant advances in therapeutic options, pressure ulcers continue to pose a challenge to physicians and surgeons and frequently require multidisciplinary input. In addition, they place huge financial burdens on health care providers. Generally classified as grades I to IV depending on the extent and severity of the ulcer, grades I and II are usually amenable to conservative management. Grades III and IV may require surgical intervention, which could either be simple debridement or complex reconstructive microsurgery. Direct closure or skin grafting is useful in only a small number of early pressure ulcers. For non-healing and advanced pressure ulcers, reconstructive surgery is indicated, which consists of soft tissue flap coverage such as fasciocutaneous, musculocutaneous, perforator, or free flaps. The selection of a particular flap depends on a variety of factors, for instance, the location and grade of the ulcer, vascularity of the surrounding tissue, mobility of the patient, and the experience and expertise of the surgeon. There are no clear guidelines at present regarding the suitability of a particular flap in the management of pressure ulcers at different stages. This article aims to provide an overview of the etiology, pathophysiology, and management of pressure ulcers in various anatomical locations, with particular emphasis on current advances in reconstructive surgical procedures.     

Efficacy of advanced dressings in the treatment of pressure ulcers: a systematic review

A meta-analysis of published research enabled dressing efficacy to be estimated. Comparisons showed greater efficacy of hydrocolloid dressings but failed to confirm advantages of other advanced dressings compared with conventional ones.     

Prospective,multicenter study of managing lower extremity venous ulcers

Seventy patients with 90 venous ulcers were randomly assigned to hydrocolloid or conventional dressing and compression therapy at four study centers. The ulcers had been present for a mean of 47.8 in the control and 46.2 weeks in the treatment group and 42% of all patients had recurrent ulcers. Ulcers treated with hydrocolloid dressings reduced 71% and control treated wounds reduced 43% in area after 7.2 weeks of treatment. Thirty-four percent of all ulcers healed. Mean time to healing was 7 weeks for the hydrocolloid dressing group and 8 weeks for the control group. Most ulcers were less painful at final evaluation, but reduction in pain was more pronounced in hydrocolloid-dressed ulcers (p =0.03). At baseline as well as during follow-up, significant differences between study centers were observed. Ulcers in patients in the United Kingdom were larger and less likely to heal ( p =0.001). Size of the ulcer at baseline was associated with treatment response and time to healing ( p =0.002). Percent reduction in ulcer area after 2 weeks was also correlated with treatment outcome ( p =0.004) and time to healing ( p =0.002). When all treatment outcome predictors were analyzed together, only percent reduction in area after 2 weeks remained statistically significant ( p =0.002), with percent reduction during the first 2 weeks of treatment >30% predicting healing.     

Interim analysis of a prospective,randomized trial of vacuum-assisted closure versus the healthpoint system in the management of pressure ulcers

Twenty-eight patients with 41 full-thickness decubitus ulcers were randomized to compare the Vacuum-Assisted Closure device (VAC) with the Healthpoint System (HP) of wound gel products in promoting ulcer healing. A total of 22 patients with 35 full-thickness ulcers completed the 6-week trial of treatment, during which time 2 patients (10%) in the VAC group (N =20) and 2 patients (13%) in the HP group (N = 15) healed completely. The mean percent reduction in ulcer volume was 42.1% with HP and 51.8% with VAC (p = 0.46). The mean number of PMNs and lymphocytes per high-power field decreased in the VAC group and increased in the HP group (p = 0.13, p = 0.41 respectively). The mean number of capillaries per high-power field was greater in the VAC group (p = 0.75). There were 15 cases of biopsy-proven osteomyelitis underlying the ulcers; three (37.5%) improved with VAC and none improved with HP (p = 0.25). VAC promotes an increased rate of wound healing and favorable histological changes in soft tissue and bone compared with HP.     

The efficacy of negative pressure wound therapy on chemotherapeutic extravasation ulcers: An experimental study

Context:

The extravasation of the chemotherapeutic agents is not an unusual phenomenon. Necrosis of the skin and underlying structures has been reported, depending on the cytotoxicity of the extravasating drug. Despite the presence of some antidotes, such wounds tend to enlarge with time and are likely to resist the treatment.

Aims:

The objective of this study was to investigate the efficacy of negative pressure wound therapy (NPWT) on extravasation ulcers.

Settings and Design:

Animals were separated into two groups; conventional dressing group and NPWT group.

Materials and Methods:

Extravasation necrosis was established by intradermal doxorubicin injection. Following the debridement of the necrotic areas, one group of animals was treated with the conventional dressing while NPWT was applied to the other group. The wound areas were measured, and then biopsies were taken on the 3^rd, 7^th and 14^th days after the debridement.

Statistical Analysis Used:

SPSS 11.5 for Windows was used. Two-way ANOVA test was used to compare wound areas between groups. Willcoxon sign test with Bonferroni correction was used to compare histological scores between groups. Chi-square test with Bonferroni correction was used to compare histological scores within the group between the days.

Results:

There is no significant difference in terms of inflammatory cell count, neovascularisation, granulation tissue formation between the groups. Contrary to these results wound areas at the end of the treatment were smaller in the NPWT group compared with the dressing group.

Conclusion:

There is the superiority of NPWT over conventional dressing in chemotherapeutic extravasation wounds as well as the wound area is concerned, but it is not proven histologically.KEY WORDS: Chemotherapeutic extravasation, extravasation ulcer, negative pressure wound therapy, rabbit     

The efficacy of hydrogel dressings as a first aid measure for burn wound management in the pre‐hospital setting: a systematic review of the literature

The aim of this systematic review was to determine the supporting evidence for the clinical use of hydrogel dressings as a first aid measure for burn wound management in the pre‐hospital setting. Two authors searched three databases (Ovid Medline, Ovid Embase and The Cochrane Library) for relevant English language articles published through September 2014. Reference lists, conference proceedings and non‐indexed academic journals were manually searched. A separate search was conducted using the Internet search engine Google to source additional studies from burns advisory agencies, first aid bodies, military institutions, manufacturer and paramedic websites. Two authors independently assessed study eligibility and relevance of non‐traditional data forms for inclusion. Studies were independently assessed and included if Hydrogel‐based burn dressings (HBD) were examined in first aid practices in the pre‐hospital setting. A total of 129 studies were considered for inclusion, of which no pre‐hospital studies were identified. The review highlights that current use of HBD in the pre‐hospital setting appears to be driven by sources of information that do not reflect the paramedic environment. We recommend researchers in the pre‐hospital settings undertake clinical trials in this field. More so, the review supports the need for expert consensus to identify key demographic, clinical and injury outcomes for clinicians and researchers undertaking further research into the use of dressings as a first aid measure.     

Clinical effect of bovine amniotic membrane and hydrocolloid on wound by laser treatment: Prospective comparative randomized clinical trial

Bovine amniotic membrane (BAM) has been regarded as an ideal dressing material because it accelerates epithelization and has anti‐inflammatory, anti‐angiogenic, and strong analgesic effects. To evaluate the clinical effects of BAM and compare them to that of hydrocolloid dressings on wounds created by ablative laser treatments, 49 subjects with nevi or scars requiring ablative laser treatment were evaluated. To compare efficacy, we divided the body into six areas and included patients with two or more similar skin lesions in the same body area. After ablative laser treatments, BAM and hydrocolloid dressing were applied to the wounds with random allocation. Clinical assessments were performed at baseline, 1, 4, 6, 8, 11, and 13 days after treatment. Histologic changes were assessed by skin biopsy. BAM treatment induced faster epithelization than hydrocolloid treatment (6.7 vs. 9.2 days). Erythema and oozing faded more quickly, and the satisfaction score was higher in BAM‐treated sites than it was in hydrocolloid‐treated sites, without severe adverse effects. Histologic analysis confirmed epithelization and immunohistochemistry revealed different growth factor profiles between the two treatment modalities. BAM benefits wound healing following ablative laser treatment.     

Effect of electrolyzed oxidizing water and hydrocolloid occlusive dressings on excised burn,wounds in rats

Objective: To study the efficacy of electrolyzed oxidizing water (EOW) and hydrocoHoid occlusive dressings in the acceleration of epithelialization in excised burn-wounds in rats. Methods: Each of the anesthetized Sprague-Dawley rats (n = 28 ) was subjected to a third-degree burn that covered approximately 10 % of the total body surface area.Rats were assigned into four groups: Group I (no irrigation), Group Ⅱ (irrigation with physiologic saline ),Group Ⅲ (irrigation with EOW ) and Group IV(hydrocolloid occlusive dressing after EOW irrigation ).Wounds were observed macroscopically until complete epithelialization was present, then the epithelialized wounds were examined microscopically. Results: Healing of the burn wounds was the fastest in Group IV treated with hydrocolloid occlusive dressing together with EOW. Although extensive regenerative epidermis was seen in each Group, the proliferations of lymphocytes and macrophages associated with dense collagen deposition were more extensive in Group Ⅱ, Ⅲ and IV than in Group I. These findings were particularlyevident in Group Ⅲ and IV. Conclusions: Wound Healing may be accelerated by applying a hydrocolloid occlusive dressing on burn surfaces after they are cleaned with EOW.     

Effect of hydrogel grafting,water and surfactant wetting on the adherence of PET wound dressings

Traditional wound dressings, including cotton gauze, absorbent pads and bandages, can cause trauma and pain to wounds during dressing changes, leading to a variety of physical and psychosocial sequelae. The aim of this study was to adapt an in vitro model of adherence to evaluate the effects of various methods to theoretically reduce the adherence of wound dressings. Gelatin in liquid form was cast onto poly(ethylene terephthalate) (PET) fabric and allowed to solidify and progressively dry to simulate wound desiccation in the clinical setting. A 180° peel test of PET from the gelatin slab yielded adherence data of peeling energy. The peeling energy of PET increased with the drying time. It was possible to reduce the force by drying at 75% relative humidity (RH). After drying for 24 h, either 500 μL of water or surfactant solution was added onto the PET surface (16 × 60 mm²). The peeling energy decreased dramatically with wetting and there was no significant difference between water and surfactant. As a long-term strategy for decreasing adherence, a thin layer of polyacrylamide (PAM) hydrogel was deposited onto PET fabric via UV irradiation. This resulted in a much lower peeling energy without severely compromising fabric flexibility. This hydrogel layer could also serve as a reservoir for bioactive and antimicrobial agents which could be sustainably released to create a microbe-free microenvironment for optimized wound healing.