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1.
In chronic wounds, excess levels and activity of proteases such as elastase and plasmin have been detected. Oxidised regenerated cellulose/collagen matrix (ORC/collagen matrix) has been reported to ameliorate the wound microenvironment by binding and inactivating excess proteases in wound exudates. In this study, the levels and activity of elastase and plasmin in wound exudates of pressure sore ulcers were measured to determine the beneficial effect of ORC/collagen matrix treatment compared with control treatment with a foam dressing. A total of 33 patients with pressure sores were enrolled in the study and were followed up for 12 weeks after treatment. Ten control patients were treated with a foam hydropolymer dressing (TIELLE®, Systagenix), and the remaining 23 patients were treated with ORC/collagen matrix plus the foam dressing (TIELLE®, Systagenix) on top. Wound assessments were carried out over 12 weeks on a weekly basis, with dressing changes twice a week. Ulcers were photographed and wound exudates were collected on admission and at days 5, 14 and then every 14 days to provide a visual record of any changes in appearance of the ulcer and healing rate and for biochemical analysis of the wound. The levels and activity of elastase and plasmin were measured in wound exudates. Statistical analysis was performed using ANOVA and Bonferroni's post hoc test with P‐values <0·05 considered to be significant. Compared with controls, ORC/collagen matrix–treated pressure sore wounds showed a significant faster healing rate, which positively correlated with a decreased activity of elastase and plasmin in wound exudates. No signs of infection or intolerance to the ORC/collagen matrix were observed.  相似文献   

2.
In this study, the effects of the wound‐covering materials, Acticoat® and Cutinova Hydro®, on wound healing have been studied in rabbit models with open and tissue‐lost wounds with full‐thickness flank excisions. Rabbits were used as subjects with three groups of four rabbits each, and trial periods of 7, 14 and 21{\uns}days. Four circular wounds, of 1.5 cm diameter were made two on the right (one of them control) and two on the left (one of them control) of the dorsal sides of the abdomen. Acticoat® and Cutinova Hydro® were applied on the wounds with suture for a period of 21 days and one each placed on the right and left sides as control with gauze. Biopsy specimens were taken from the animals at the end of the research period to check the length of the epithelium, epithelial thickness, size of wounds, wound granulation tissue formation and histopathological evaluation for clarity. The Acticoat® group showed better healing and scar formation compared to the Cutinova Hydro® group by macroscopic examination. Epithelial wound length and clarity in terms of statistical difference occurred on day 21 (P <0.05); while the length of the wound epithelium decreased patency, epithelial thickness on days~7, 14 and 21, showed no statistical differences (P >0.05). As a result, the Acticoat® wound dressing was determined as a more reliable for the early wound healing. This study has shown the short‐term clinical benefits of hydroactive, polyurethane dressings in the management of acute wounds. However, longer periods of wound healing procedure should be planned for reliable and safe results of wound dressing. It has also been concluded that microbiological analyses should be included for more robust and reliable comparisons.  相似文献   

3.
This study investigated whether there are differences in the ability of wound dressings to modulate certain factors known to affect wound healing. A selection of antimicrobial dressings (AQUACEL ® Ag Extra, AQUACEL ® Ag+ Extra, IODOFLEX , ACTICOAT 7 and PROMOGRAN PRISMA matrix) were tested for their effect on both bacterial bioburden and human dermal fibroblasts. Some dressings underwent further evaluation for activity against Pseudomonas aeruginosa biofilms using a colony‐drip flow reactor model. The ability of in vitro biofilms to produce proteases, and the effect of PROMOGRAN PRISMA matrix on such proteases, was also investigated. All antimicrobial dressings tested reduced vegetative bacterial load; however, only PROMOGRAN PRISMA matrix was able to significantly reduce biofilm populations (P = 0·01). Additionally, PROMOGRAN PRISMA matrix was the only dressing that did not inhibit dermal fibroblast growth. All other dressings were detrimental to cell viability. In vitro biofilms of Pseudomonas aeruginosa were demonstrated as being capable of releasing bacterial proteases into their surroundings, and incubation with PROMOGRAN PRISMA matrix led to a 77% reduction in activity of such proteases (P = 0·002). The unique ability of PROMOGRAN PRISMA matrix to reduce in vitro vegetative bacteria, biofilm bacteria and bacterial proteases while still allowing dermal fibroblast proliferation may help rebalance the wound environment and reduce the occurrence of infection.  相似文献   

4.
In the treatment and monitoring of a diabetic or chronic wound, accurate and repeatable measurement of the wound provides indispensable data for the patient's medical record. This study aims to measure the accuracy of the laser‐assisted wound measurement (LAWM) device against traditional methods in the measurement of area, depth and volume. We measured four ‘healing’ wounds in a Play‐Doh®‐based model over five subsequent states of wound healing progression in which the model was irregularly filled in to replicate the healing process. We evaluated the LAWM device against traditional methods including digital photograph assessment with National Institutes of Health ImageJ software, measurements of depth with a ruler and weight‐to‐volume assessment with dental paste. Statistical analyses included analysis of variance (ANOVA) and paired t‐tests. We demonstrate that there are significantly different and nearly statistically significant differences between traditional ruler depth measurement and LAWM device measurement, but there are no statistically significant differences in area measurement. Volume measurements were found to be significantly different in two of the wounds. Rate of percentage change was analysed for volume and depth in the wound healing model, and the LAWM device was not significantly different than the traditional measurement technique. While occasionally inaccurate in its absolute measurement, the LAWM device is a useful tool in the clinician's arsenal as it reliably measures rate of percentage change in depth and volume and offers a potentially aseptic alternative to traditional measurement techniques.  相似文献   

5.
Non healing wounds present a significant social and economic burden. Chronic non healing wounds are estimated to affect as many as 1–2% of individuals during their lifetime, and account for billions of dollars of expense annually on both a national and global basis. Our purpose is to describe the use of a novel dehydrated amniotic membrane allograft (EpiFix®; MiMedx Group, Inc., Kennesaw, GA) for the treatment of chronic non healing wounds. We describe the results of EpiFix treatment in four patients who had not achieved wound closure with both conservative and advanced measures, and had been referred for a definitive plastic surgery procedure. Healing was observed in a variety of wounds with one to three applications of the dehydrated amniotic membrane material. The material was well tolerated by patients. Healed wounds did not recur in long‐term follow‐up. Further investigation of the use of dehydrated amniotic membrane in broader application to various types of dermal wounds should be considered.  相似文献   

6.
Ankaferd Blood Stopper® (ABS) is a folkloric medicinal plant extract used as a haemostatic agent in traditional Turkish medicine. The aim of this study was to investigate the efficacy of ABS on the healing of dermal wounds in a rat model. Twenty Wistar albino rats were divided into two groups. Standard full‐thickness skin defects were created on the back of the rats. In the control group (group 1), dressings moisturised with saline were changed daily. In the study group (group 2), the wounds were cleaned daily with saline, Ankaferd solution was applied, then the wounds were covered with moisturised dressings. The contraction percentage of wound areas were calculated on the 3rd, 7th, 10th and 14th days using a planimetric programme. On day 14, the wound areas were excised for histopathological examination, inflammatory scoring and evaluation of collagen deposition. The study group was superior to the control group in terms of inflammatory scoring, type I/type III collagen ratio and wound contraction rates. ABS® may be used effectively and safely on full‐thickness wounds as a natural product.  相似文献   

7.
A combination of 0.1% octenidine dihydrochloride and 2% 2‐phenoxyethanol (octenisept®) is a commonly used disinfectant in human medicine. As porcine skin represents an adequate model for human skin, the effect of octenidine dihydrochloride and phenoxyethanol on wound healing is studied in pigs. Furthermore, the in vitro percutaneous permeation of the test substances is studied. The impact of the test formulations on wound healing is examined (A) under non occlusive conditions and (B) in comparison to another disinfectant based on povidone‐iodine under occlusive conditions, while wounds are treated daily with the test substances. The percutaneous permeation of octenidine dihydrochloride and phenoxyethanol is studied in Franz‐type diffusion cells with intact skin as well as barrier disrupted after tape stripping. Compared with povidone‐iodine or vehicle treatment as well as untreated control wounds the treatment of wounds with the test formulation has no influence on the healing rate in pigs and does not induce retardation of wound healing. The in vitro diffusion experiment reveals that octenidine dihydrochloride is only detectable in the acceptor chamber of three‐barrier disrupted skin samples. Phenoxyethanol permeates through intact porcine skin in amounts of 11.3% and through barrier disrupted skin in amounts of 43.9%  相似文献   

8.
How differential gene expression affects wound healing is not well understood. In this study, Zucker diabetic fatty (fa/fa) male inbred rats were used to investigate gene expression during wound healing in an impaired wound‐healing model. Whole genome microarray surveys were used to gain insight into the biological pathways and healing processes in acute excisional wounds treated with vacuum‐assisted closure (V.A.C.®) Therapy, moist wound healing (MWH) or gauze under suction (GUS). Global gene expression analyses after 2 days of healing indicated major differences with respect to both number of genes showing fold changes and pathway regulation between the three different wound treatments. Statistical analysis of expression profiles indicated that 5072 genes showed a >1·6‐fold change with V.A.C. Therapy compared with 3601 genes with MWH and 3952 genes with GUS. Pathways and related genes associated with the early phases of wound healing diverged between treatment groups. For example, pathways involving angiogenesis, cytoskeletal regulation and inflammation were associated with elevated gene expression following V.A.C. Therapy. This study is the first to assess wound healing by whole genome interrogation in a diabetic rat model treated with different healing modalities.  相似文献   

9.
Our purpose was to compare healing characteristics of diabetic foot ulcers treated with dehydrated human amniotic membrane allografts (EpiFix®, MiMedx, Kennesaw, GA) versus standard of care. An IRB‐approved, prospective, randomised, single‐centre clinical trial was performed. Included were patients with a diabetic foot ulcer of at least 4‐week duration without infection having adequate arterial perfusion. Patients were randomised to receive standard care alone or standard care with the addition of EpiFix. Wound size reduction and rates of complete healing after 4 and 6 weeks were evaluated. In the standard care group (n = 12) and the EpiFix group (n = 13) wounds reduced in size by a mean of 32·0% ± 47·3% versus 97·1% ± 7·0% (P < 0·001) after 4 weeks, whereas at 6 weeks wounds were reduced by ?1·8% ± 70·3% versus 98·4% ± 5·8% (P < 0·001), standard care versus EpiFix, respectively. After 4 and 6 weeks of treatment the overall healing rate with application of EpiFix was shown to be 77% and 92%, respectively, whereas standard care healed 0% and 8% of the wounds (P < 0·001), respectively. Patients treated with EpiFix achieved superior healing rates over standard treatment alone. These results show that using EpiFix in addition to standard care is efficacious for wound healing.  相似文献   

10.
Chronic wounds are commonly associated with high morbidity rates due to the patient's need of frequent dressing changes and repeated visits to the outpatient wound clinic. Furthermore, chronic wounds are often characterised by severe pain, which can cause significant disability to the patient. New technologies aim to develop an optimal device to reduce discomfort of the patient and to heal wounds. The device Rexon‐age® is introduced for the first time in wound healing, and preliminary data on clinical and histological results are shown. From April 2014 to April 2015, 11 patients – 7 females and 4 males – were enrolled in the present study. The study was conducted at the Plastic and Reconstructive Institute of the Università degli Studi di Torino, Città della Salute e della Scienza of Torino, Italy. For histological characterisation, pre‐ and post‐treatment biopsies on the wound bed were performed. Data regarding age, gender, weight, height, comorbidity, drug therapy and topical pre‐treatment and dressings of the wound were collected as well. Moreover, local factors regarding the wound data were as follows: aetiology, time of the wound formation until first Rexon‐age treatment, wound dimensions, wound bed, moisture, margins and anatomical region of the wound. A visual analogue scale (VAS) was used to monitor the pain before and after each treatment. Rexon‐age treatment resulted in improvement in granulation tissue and wound contraction. Moreover, a significant reduction of pain was observed with the reduction of painkillers drug usage. Among these Rexon‐age‐treated patients, three patients displayed 60–80% reduction in pain intensity, and two patients showed complete pain relief. In outpatient follow‐up appointments, we registered long‐term durability of pain relief. As assessed by histological analyses, post‐treatment biopsies of all nine patients revealed a decreased amount of inflammatory cells and lower expression levels of metalloproteinases (e.g. MMP9). We observed increased capillary thrombosis as well as up‐regulation of vascular endothelial growth factor (VEGF) expression. The current study presents the first evidence that Rexon‐age‐based therapy can significantly ameliorate and accelerate the healing process of chronic wounds. Although this study analysed only a small number of patients, we could consistently observe positive effects on both the clinical aspect of the lesions, which underwent size reduction and wound reactivation, and the quality of life of our patients due to long‐term pain relief.  相似文献   

11.
To create a moist environment for rapid wound healing, a hydrosheet composed of alginate, chitin/chitosan, and fucoidan (ACF‐HS) has been developed as a functional wound dressing. The aim of this study was to evaluate the accelerating effect of ACF‐HS on wound healing for rat mitomycin C‐treated healing‐impaired wounds. Full‐thickness skin defects were made on the back of rats and mitomycin C was applied onto the wound for 10 minutes to prepare a healing‐impaired wound. After thoroughly washing out the mitomycin C, ACF‐HS was applied to the healing‐impaired wounds. The rats were later euthanized and histological sections of the wounds were prepared. The histological examinations showed significantly advanced granulation tissue and capillary formations in the healing‐impaired wounds treated with ACF‐HS on days 7 and 14, in comparison with that in alginate fiber (Kaltostat®), hydrogel wound dressing (DuoACTIVE®), and nontreatment (negative control). Furthermore, in cell culture studies, ACF‐HS‐absorbed serum and fibroblast growth factor‐2 was found to be proliferative for fibroblasts and endothelial cells, respectively, and ACF‐HS‐absorbed serum was found to be chemoattractive for fibroblasts. However, our results may not be strictly comparable with general healing‐impaired wound models in humans because of the cell damage by mitomycin C. In addition, more biocompatibility studies of fucoidan are essential due to the possibility of renal toxicity.  相似文献   

12.
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.  相似文献   

13.
Oxygen‐based therapies have proven effective in treating chronic and difficult‐to‐heal skin wounds, but the current therapeutic approaches suffer from major limitations and they do not allow for continuous wound treatment. Here we examined whether the continuous treatment of wounds with pure oxygen at low flow rates accelerates wound closure and improves wound healing in a murine model of diabetic skin wounds. Two full‐excisional dorsal skin wounds were generated on 15‐week‐old diabetic db/db mice and treated for 10 weeks continuously with pure oxygen (>99·9%) at low flow rates (3 ml/h). After 6 days, oxygen treatment resulted in a mean reduction of the original wound size by 60·2% as compared with only 45·2% in wounds on control mice that did not receive pure oxygen.(P = 0·022). After 10 days, oxygen‐treated wounds were 83·1% closed compared with 71·2% in wounds on control mice. While reepithelialisation was complete after 10 days in over 57% of wounds receiving low flow oxygen treatment, significant epithelial gaps remained in 75% wounds from mice that did not receive oxygen. Continuous low flow oxygenation significantly improves healing of diabetic skin wounds in mice and may therefore be an effective treatment for chronic cutaneous and possibly other slow‐healing wounds in diabetic patients.  相似文献   

14.
ObjectiveAcceleration of wound healing promises advantages for patients and caregivers in reducing the burden of disease, avoiding complications such as wound infections, and improving the long-term outcome. However, medicines that can accelerate wound healing are lacking. The objective of this open, blindly evaluated, randomized, multicenter phase III study was to compare intra‐individually the efficacy and tolerability of Oleogel‐S10 with fatty gauze dressing versus Octenilin® wound gel with fatty gauze dressing in accelerating the healing of superficial partial thickness burn wounds.MethodsAcute superficial partial thickness burn wounds in adults caused by fire, heat burn or scalding were divided into 2 halves and randomly assigned to treatment with Oleogel‐S10 or Octenilin® wound gel. Photos for observer‐blinded analysis of wound healing were taken at each wound dressing change. Percentages of reepithelialization were assessed at defined intervals. Efficacy and tolerability were evaluated based on a 5‐point Likert scale.ResultsOf 61 patients that were enrolled, 57 received the allocated intervention and 48 completed treatment. The percentage of patients with earlier wound healing was significantly higher for Oleogel‐S10 (85.7%, n = 30) compared to Octenilin® wound gel (14.3%, n = 5, p < 0.0001). The mean intra‐individual difference in time to wound closure was −1.0 day in favour of Oleogel‐S10 (−1.4, −0.6; 95% CI, p < 0.0001). Most investigators (87.0%) and patients (84.8%) evaluated the efficacy of Oleogel‐S10 to be ‘better’ or ‘much better’ than that of Octenilin® wound gel. Long-term outcome 3 months and 12 months post injury was improved in some patients.ConclusionsOleogel‐S10 (Episalvan) significantly accelerated the healing of superficial partial thickness burn wounds. It was safe and well tolerated.  相似文献   

15.
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.  相似文献   

16.
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.  相似文献   

17.
Various types of wound dressings have been designed for different purposes and functions. Controlling bacterial burden in a wound during the early phase is important for successful wound repair. Once bacterial burden is under control, the active promotion of wound healing is another important factor for efficient wound healing. This study investigated the potential of three silver‐containing dressings, namely KoCarbonAg®, Aquacel® Ag and Acticoat 7, in reducing bacterial survival and promoting wound healing. The ability of these dressings to block the entry of bacteria from external environment and retain intrinsic bacteria was studied in vitro. In addition, the study used a rat model to compare the healing efficiencies of the three dressings and investigate the quantity of collagen synthesis in vivo. In vitro results indicated that the silver‐containing dressings prevented bacterial growth in wounds by blocking the entry of external bacteria and by retaining the bacteria in the dressing. In vivo study indicated that reduction in bacterial burden accelerated wound healing. Wounds treated by the silver‐containing dressings showed better healing than those treated with gauze. Moreover, KoCarbonAg® further accelerated wound healing by promoting collagen synthesis and arrangement.  相似文献   

18.
It is important for caregivers and patients to know which wounds are at risk of prolonged wound healing to enable timely communication and treatment. Available prognostic models predict wound healing in chronic ulcers, but not in acute wounds, that is, originating after trauma or surgery. We developed a model to detect which factors can predict (prolonged) healing of complex acute wounds in patients treated in a large wound expertise centre (WEC). Using Cox and linear regression analyses, we determined which patient‐ and wound‐related characteristics best predict time to complete wound healing and derived a prediction formula to estimate how long this may take. We selected 563 patients with acute wounds, documented in the WEC registry between 2007 and 2012. Wounds had existed for a median of 19 days (range 6–46 days). The majority of these were located on the leg (52%). Five significant independent predictors of prolonged wound healing were identified: wound location on the trunk [hazard ratio (HR) 0·565, 95% confidence interval (CI) 0·405–0·788; P = 0·001], wound infection (HR 0·728, 95% CI 0·534–0·991; P = 0·044), wound size (HR 0·993, 95% CI 0·988–0·997; P = 0·001), wound duration (HR 0·998, 95% CI 0·996–0·999; P = 0·005) and patient's age (HR 1·009, 95% CI 1·001–1·018; P = 0·020), but not diabetes. Awareness of the five factors predicting the healing of complex acute wounds, particularly wound infection and location on the trunk, may help caregivers to predict wound healing time and to detect, refer and focus on patients who need additional attention.  相似文献   

19.
In stalled, chronic wounds, more aggressive and proactive wound closure efforts are needed. We describe adjunctive use of epidermal grafting in patients with chronic wounds. Wound bed preparation consisted of surgical necrotectomy or sharp debridement, hyperbaric oxygen therapy, negative pressure wound therapy, compression therapy, platelet‐rich plasma therapy and/or heparan sulphate agents. Epidermal grafts were harvested from the patient's thigh and applied to the wound. Wound and donor site healing was monitored. A total of 78 patients (average age = 64·1 ± 15·6 years) were included in the study. Common comorbidities included hypertension (47·4%), venous insufficiency (37·2%) and obesity (28·2%). Average wound duration was 13·2 months (range: 0·3–180 months). The most common wound types were dehiscence (29·5%), radiation ulcer (24·4%) and venous ulcer (17·9%). Total time from epidermal grafting to wound closure was 10·0 ± 7·3 weeks. Of the 78 wounds, 66 (84·6%) reached full wound closure (49 < 3 months, 16 > 3 months, 1 without time data). Of 78 wounds, 10 (12·8%) underwent partial wound healing, while 2 wounds (2/78; 2·6%) remained unhealed. These results suggest that wound surface reduction can be achieved by proactive early application of biological therapies and epidermal skin grafts, which may help decrease time to wound healing.  相似文献   

20.
The purpose of this study was to compare the ultraportable mechanically powered Smart Negative Pressure (SNaP®) Wound Care System to the traditional electrically powered Vacuum‐Assisted Closure (VAC®) Therapy System in the treatment of chronic lower extremity wounds. This 12‐center randomized‐controlled trial of patients with noninfected, nonischemic, nonplantar lower extremity wounds had enrolled 65 patients, as of January 5, 2010, at the time of a planned interim analysis. Subjects were randomly assigned to treatment with either the SNaP® or VAC® Systems. The trial evaluated treatment for up to 16 weeks or till complete closure was achieved. Fifty‐three patients (N=27 SNaP®, N=26 VAC®) completed at least 4 weeks of therapy. Thirty‐three patients (N=18 SNaP®, N=15 VAC®) completed the study with either healing or 16 weeks of therapy. At the time of planned interim analysis, no significant differences (p=0.99) in the proportion of subjects healed between the two devices evaluated were found. In addition, the percent wound size reduction between treatment groups was not significantly different at 4, 8, 12, and 16 weeks, with noninferiority analysis at 4 weeks of treatment reaching the p‐value <0.05 significance level (*p=0.019). These interim data suggest no difference in wound closure between the SNaP® System and the VAC® System in the population studied. We look forward to the final analysis results.  相似文献   

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