Randomized Controlled Study Comparing Disposable Negative-Pressure Wound Therapy with Standard Care in Bilateral Breast Reduction Mammoplasty Evaluating Surgical Site Complications and Scar Quality.

BACKGROUND: Negative pressure wound therapy (NPWT) for postsurgical incision treatment has demonstrated benefits. A prospective randomized study was developed including 32 patients who underwent bilateral breast reduction mammoplasty. Patients served as their own control and received NPWT to one breast and fixation strips to the other breast. METHODS: The primary outcome was the number of wound healing complications within 21 days when comparing NPWT treatment with fixation strips. The secondary outcome was aesthetic appearance and quality of scarring using questionnaires [visual analogue scale (VAS) and Patient and Observer Scar Assessment Scale (POSAS)] scored at day 42-, 90-, 180- and 365-day follow-up using additional scar measurement modalities, such as viscoelasticity. RESULTS: For the 32 included patients, the number of wound complications was significantly lower (p < 0.004) for the NPWT treated sites compared to fixation strips. POSAS and VAS scores at 42 and 90 days revealed a significantly better quality of scarring in the NPWT treatment breasts than in fixation strips. At 180-day follow-up, there was a significant improvement in total VAS scores, as well as a comparable improvement in POSAS scores. No consistent significant improvement in scar quality was demonstrated with the assays that were used. CONCLUSIONS: Our study showed less complications and a significant improvement in quality of scarring in favor of the NPWT-treated sites. The results indicate NPWT to be an attractive option for these patients. LEVEL OF EVIDENCE II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Correction to: Randomized Controlled Study Comparing Disposable Negative-Pressure Wound Therapy with Standard Care in Bilateral Breast Reduction Mammoplasty Evaluating Surgical Site Complications and Scar Quality.

The second to last sentence in the Results section of the Abstract should be corrected to, "At 180-days follow-up, there was a significant improvement in total VAS scores."

Compression therapy for venous leg ulcers: risk factors for adverse events and complications, contraindications - a review of present guidelines.

INTRODUCTION: The adequate use of compression in venous leg ulcer treatment is equally important to patients as well as clinicians. Currently, there is a lack of clarity on contraindications, risk factors, adverse events and complications, when applying compression therapy for venous leg ulcer patients. METHODS: The project aimed to optimize prevention, treatment and maintenance approaches by recognizing contraindications, risk factors, adverse events and complications, when applying compression therapy for venous leg ulcer patients. A literature review was conducted of current guidelines on venous leg ulcer prevention, management and maintenance. RESULTS: Searches took place from 29th February 2016 to 30th April 2016 and were prospectively limited to publications in the English and German languages and publication dates were between January 2009 and April 2016. Twenty Guidelines, clinical pathways and consensus papers on compression therapy for venous leg ulcer treatment and for venous disease, were included. Guidelines agreed on the following absolute contraindications: Arterial occlusive disease, heart failure and ankle brachial pressure index (ABPI) <0.5, but gave conflicting recommendations on relative contraindications, risks and adverse events. Moreover definitions were unclear and not consistent. CONCLUSIONS: Evidence-based guidance is needed to inform clinicians on risk factor, adverse effects, complications and contraindications. ABPI values need to be specified and details should be given on the type of compression that is safe to use. Ongoing research challenges the present recommendations, shifting some contraindications into a list of potential indications. Complications of compression can be prevented when adequate assessment is performed and clinicians are skilled in applying compression.

Randomized controlled trial comparing treatment outcome of two compression bandaging systems and standard care without compression in patients with venous leg ulcers.

BACKGROUND: In Hong Kong, at the time of the study, compression treatment was not considered usual care for venous leg ulcer patients. AIM: This randomized controlled trial compared quality of life (QOL) aspects in venous leg ulcer patients of over 55-years of age, of short-stretch compression (SSB), four-layer compression bandaging (4LB) and usual care (UC) (moist wound healing dressing, no compression). METHOD: Study period was 24-weeks, the primary outcome was the patient functional status, disease-specific and generic health-related QOL measures and ulcer healing rates, comparing week 1 vs. week 24 (end) results. Assessments included photogrammetry, Brief Pain Inventory, SF-12 Health Survey, Charing Cross Venous Ulcer Questionnaire and Frenchay Activity Index. Data analysis was performed using, where appropriate; Kaplan Meier and log rank chi-square and the repeated measures analysis of variance test. RESULTS: A total of 321 patients participated in the study, 45 (14%) withdrew for various reasons. Compression bandaging in both groups significantly reduced pain (P < 0.0001) and improved functional status and QOL. Healing rate at 24 weeks for both compression groups was significant (P < 0.001); for SSB this was 72.0% (77/107) vs. 67.3% in the 4LB group (72/107) and 29.0% (31/107) with usual care. The reduction in ulcer area from weeks 12 to 24 was significant only for SSB (P < 0.047). CONCLUSION: Compression was shown to be feasible for elderly community care patients in Hong Kong and is currently implemented as part of standard venous leg ulcer treatment.

An RCT to compare a bio-cellulose wound dressing with a non-adherent dressing in VLUs.

OBJECTIVE: To compare the efficacy of a bio-cellulose dressing (BWD) versus a non-adherent wound contact layer in venous leg ulcer (VLU) outpatients. METHOD: In a prospective, randomised, controlled multicentre study, 48 VLU patients were randomised to receive compression bandages and either standard care (non-adherent dressing; n=23) or a BWD (Suprasorb X; n=25). VLUs were evaluated for debridement efficacy, time to 75-100% granulation and ≥ 50% re-epithelialisation, reduction of ulcer size and patient-reported ulcer pain, comparing the status at day 0 and weekly, over a 12-week study treatment period. RESULTS: Thirty-three patients (n=18 BWD and n=15 control dressing) were included in the analysis. Autolytic debridement was significantly faster in the BWD group, with an 84% removal of yellow tissue compared with 26% in the control group, over the 12-week period (p < 0.0001). A median of 25 days were required to achieve 75-100% granulation in the BWD group vs 36 days for controls. A median of 36 days was taken to achieve ≥ 50% re-epithelialisation in the BWD group vs 50 days for controls. Patient-reported ulcer pain reduced significantly faster in the BWD group (p < 0.05), by week 7, 100% of patients reported no pain, compared with 63% of controls. CONCLUSION: Autolytic debridement was faster and more effective in the BWD group compared with standard care, as was pain reduction. Although the time to healing was shorter with the BWD vs standard care, the difference was not statistically significant. DECLARATION OF INTEREST: This study was supported by Xylos Corporation. The study product was called X-Cell at the time, and is now available as Suprasorb X (Lohmann & Rauscher). Each principal investigator (Alvarez, Phillips, Menzoian, Etris-Brown) and respective clinical centre received funding for the conduct of the study. Each site executed a clinical study agreement independently with the sponsor. The sponsors had no role in the design and conduct of the study, in the collection, analysis, or interpretation of data, or in the preparation of the manuscript, review, or approval of the manuscript. None of the authors received administrative, technical or material support for the conduct of this study. The authors have no relevant financial interest in this article.

Randomised, controlled pilot to compare collagen and foam in stagnating pressure ulcers.

OBJECTIVE: To compare the clinical efficacy of a collagen dressing covered with a foam dressing with the same foam used as a primary dressing in stagnating granulating pressure ulcer patients. METHOD: Patients were randomised to receive either a foam dressing (Suprasorb P; Lohmann & Rauscher) as a primary dressing (group A), or a combination of a collagen dressing (Suprasorb C; Lohmann & Rauscher) covered with the same foam dressing (group B).Wound fluid was collected and evaluated prior to treatment (day 0), and on days 3,7, 14 and 21 .The level and expression of matrix metalloproteinases (MMPs) MMP-2 and MMP-9, and tissue inhibitors of metalloproteinases (TIMPs) TIMP- I and TIMP-2,as well as elastase content in wound fluid and angiogenesis,were evaluated, comparing results on day 0 and day 2 I.Time to ulcer healing, reduction in ulcer area, safety of treatment, patient-reported ulcer pain and comfort of the dressing regimen were evaluated as secondary outcomes. Patients received standard preventive measures, in line with the pressure ulcer prevention guidelines. RESULTS: Ten patients were included in the pilot; five were treated with the foam dressing (group A) and five patients received the collagen dressing, using the foam as a secondary dressing (group B).Wound fluid from group B displayed a significant positive effect on angiogenesis (p < 0.05) compared with group A. In the collagen and foam groupTIMP- I and -2 increased faster and levels were higher than in group A. Furthermore, MMP-2, MMP-9 (p < 0.04) and elastase in group B showed faster and greater decrease in levels, compared with group A, indicating a faster and superior reduction of inflammation. In both groups the ulcers started to heal, with a faster onset of healing for group B. CONCLUSION: The results of this pilot support published data on the use of collagen dressings compared with foam for stagnating wounds, shown in clinical studies. DECLARATION OF INTEREST: This study was supported with an educational grant by Lohmann & Rauscher GmbH.Apart from DrAbel, the sponsors had no role in the design or conduct of the study, in the collection, analysis and interpretation of the data, or in the preparation, review or approval of the manuscript. DrAbel gave input to the study design from a scientific perspective. None of the authors received administrative, technical or material support for the conduct of this study.The authors have no other relevant financial interests to declare.

Comparison of the interface pressure and stiffness of four types of compression systems.

OBJECTIVE: To compare interface pressure (IP) and static stiffness index (SSI) of four different compression systems currently in use for the treatment of patients with venous leg ulcer. METHOD: Fifty-two ambulatory adults with healthy legs were recruited at random at a study centre after they had consented. The evaluated systems were: short-stretch system (SSB), Rosidal sys (Lohmann & Rauscher), multilayer bandaging (LSB) Profore (Smith & Nephew), Vari-stretch (VSB) ProGuide (Smith & Nephew) and tubular compression (CS) Rosidal Mobil (Lohmann & Rauscher). Interface pressure was measured using Kikuhime (Harada Corp.), placing a 3 cm-diameter probe at the B1 point. IP recording took place in the supine and standing positions, while sitting and during walking, on application of the compression systems and every 15 minutes thereafter for 4 hours. RESULTS: The IPs of SSB, LSB and VSB, measured immediately after bandage application, were significantly higher than that of CS (all p < 0.05). During the 4-hour study period, the IP for both VSB and LSB measured in the supine position initially increased to > 60 mmHg. Their overall mean IPs in the supine position were 48.96 ± 3.99 mmHg and 48.12 ± 4.57 mmHg, respectively. SSB and CS demonstrated more tolerable IP levels in this position of < 40 mmHg, which was similar to those when sitting. All systems maintained at least 40 mmHg in walking. SSB had a high SSI of 20 throughout the study. LSB followed with an SSI of 18 at the start, which reduced to 13, while the SSI for VSB decreased from 17 to 12 and CS, with an SSI of 6, lagged behind. CONCLUSION: These results may contribute to the understanding of IP and SSI of the four different compression systems evaluated. The IP and SSI data presented give clinicians an indication of the appropriate frequency of re-application of compression, and preliminary data on choosing a safe and effective compression treatment for their patients. DECLARATION OF INTEREST: The investigators received an educational grant from Lohmann & Rauscher GmbH & Co KG for this study.

A cohort study on the efficacy of a polyhexanide-containing biocellulose dressing in the treatment of biofilms in wounds.

OBJECTIVE: This cohort study evaluated the clinical efficacy of a polyhexanide-containing biocellulose dressing, Suprasorb X+PHMB (Lohmann & Rauscher GmbH), for the eradication of biofilms in non-healing wounds. Polyhexanide (PHMB) has been shown to have microbicidal activity when applied to chronic wounds and burns. METHOD: Twenty-eight patients, aged over 18 years, who presented at an outpatient wound clinic with non-healing locally infected and/or critically colonised wounds of various aetiologies that showed clinical signs of biofilm were included in the study. Sixteen patients (nine females), with a mean age of 60.9±21.6 years, were included in the analysis. The patients were prospectively followed for a maximum of 24 weeks or until healing for analysis of safety and efficacy endpoints. Evolution of wound size was conducted with tracings and standardised digital photographs as well as for determining healing rates. RESULTS: At 24 weeks,12 wounds (75%) had healed (complete epithelialisation with no drainage). Of those wounds that had not closed, the mean wound area had reduced by 61% at week 24. Ten patients (63%) had a good reduction of the biofilm, five (32%) scored moderate and one (6%) had no reduction noted at week 24. The mean percentage of granulation tissue had increased significantly (p<0.04) when comparing day 0 (38%) with week 24 (77%). Yellow tissue present in the wound bed decreased (p<0.01): 62% (day 0) versus 23% (week 24). All patients reported reduced pain after dressing change. CONCLUSION: The results suggest that continuous application of PHMB, using a biocellulose wound dressing, reduced biofilm in the stagnating wounds treated, thus promoting healing. The treatment was comfortable, safe and reduced wound pain at dressing change. The PHMB-containing biocellulose dressing seems to be suitable for lightly to moderately exuding wounds. DECLARATION OF INTEREST: This study was supported by a scientific grant from Lohmann & Rauscher.

A clinical evaluation of the efficacy and safety of singlet oxygen in cleansing and disinfecting stagnating wounds.

OBJECTIVE: This cohort study evaluated the clinical efficacy of singlet oxygen, ActiMaris (AM) a hypertonic (3%) ionised (pH 9.8) sea water solution. It was assumed that when used for wound cleansing, disinfection and the reduction of inflammation, AM would be safe and effective. METHOD: Between May 2008 and May 2009, ambulant patients presenting at one of four wound healing centres were included in the study. Patients had critically colonised and/or infected, malodorous wounds, covered with slough/fibrin or wounds showing inflammation of the periwound skin. Wounds were assessed in terms of percentage changes in fibrin, slough and granulation tissue, they were assessed clinically and high resolution digital photographs were scored by a physician who was blinded to treatment allocation. Results were compared at baseline (week 0) and following 42 days of AM treatment (week 6). RESULTS: Seventy-three patients were included in the analysis. Dressing changes were at 2-day intervals on average, and the median treatment period was 46.04 days (range: 3-197). At 42 days, 33% (n=24) of included wounds had healed, 57% (n=42) had improved and 10% (n=7) remained stagnant. Cleansing and wound disinfection with AM was effective. In 31 patients (42%) wounds had showed clinical signs and symptoms of critical colonisation and/or infection at day 0, whereas at day 42 the infection was completely eradicated. Inflammation was reduced in 60% (n=44) of cases and patients did not report pain or discomfort when using AM. CONCLUSION: The use of singlet oxygen was shown to be safe and the results of this study indicate AM to be useful for wound cleansing, disinfection, reducing inflammation and promoting wound healing. CONFLICT OF INTEREST: The centres were supplied with the study product by the sponsor. The authors have no financial interest in writing this article.

Clinical evaluation of a PHMB-impregnated biocellulose dressing on paediatric lacerations.

OBJECTIVE: To evaluate the clinical benefits, primarily tolerability and reduction in pain levels, associated with the use of a PHMB-impregnated biosynthetic cellulose dressing (Suprasorb X + PHMB) on paediatric heel lacerations. METHOD: These lacerations were caused when children, who were being transported on their parents' bicycles, got their heels trapped in the wheel spokes. Where these injuries just comprised skin contusion and laceration, treatment had previously comprised cleansing followed by application of conventional dressings and moist wound healing dressings. However, the high incidence of infection necessitated regular dressing changes, which caused parents and children stress and anxiety. This clinical evaluation assessed the benefits of a new treatment protocol, where the PHMB-impregnated biocellulose dressing was applied and left in situ until epithelialisation occurred. A cork splint was used for 3 days to prevent pes equinus and to let the ankle joint rest. Change in wound size (cm²), incidence of local infection, wound bed characteristics and pain levels (measured on a 0-10 paediatric pain scale) were assessed at 3-day intervals during the 14-day treatment period. Satisfaction with the dressing was also evaluated. RESULTS: Twenty children (mean age 5.6 years (± 1.33) were recruited into the study and included in the analysis. The mean baseline wound area was 8.60cm² (± 6.57). The mean time to complete wound closure was 12.95 days (± 7.69) with a mean total of 4.70 visits (± 1.56). The mean VAS pain score was 9.55 (± 0.69), compared with 0.15 (± 0.37) on day 14 (p<0.003). At the second visit (after 3 days) 17 of the 20 children were reported to be free of pain. No cases of local infection were noted. CONCLUSION: The dressing was found to be child and parent friendly. The evaluation also showed that it was well tolerated and achieved good healing outcome. It has now been incorporated into the clinic's treatment protocol for these wounds. CONFLICT OF INTEREST: None. The authors have no relevant financial interest in this article. All authors were involved in the critical revision of the manuscript for important intellectual content.

Monitoring the microcirculation to evaluate dressing performance in patients with venous leg ulcers.

OBJECTIVE: To compare the effect on the microcirculation in venous leg ulcers (VLUs) of two treatment regimens that promote a moist wound environment versus paraffin gauze. The hypothesis is that moist wound dressings are more likely to stimulate the microcirculation and therefore angiogenesis. METHOD: Patients with non-healing VLUs were randomised to receive either a foam dressing (Suprasorb P), a collagen dressing (Suprasorb C) plus the foam dressing, or paraffin gauze (control). All patients wore short-stretch high compression bandages. Parameters used to measure the effects of the treatments on the microcirculation were: TcPO2 measurements, video laser Doppler measurements and the number of capillaries in the wound bed. The progression towards healing was measured by the reduction in ulcer area and formation of granulation tissue. The treatment period was four weeks. RESULTS: Significant increases in TcPO2 values were reported between baseline and week 4 for patients receiving the foam dressing only or the collagen plus foam dressing combination (p<0.008 versus p<0.003 respectively). There was also a significant increase in the number of capillaries for the collagen plus foam treatment only (p<0.002). CONCLUSION: This pilot study suggests that a moist wound environment stimulates perfusion of blood and oxygen to the wound tissue, thereby promoting angiogenesis. The collagen and foam dressing combination demonstrated superior results to the control and the foam dressing only. Monitoring the microcirculation may help to assess the effect of dressings on VLU healing, although more research is needed. DECLARATION OF INTEREST: This pilot study was supported by a limited grant from Lohmann & Rauscher GmbH, Germany.

Fibreoptic bronchoscopy in routine clinical practice in confirming the diagnosis and treatment of inhalation burns.

Fibreoptic bronchoscopy has been recently introduced to our practice, its value in the diagnosis and management of respiratory tract burns has been well established. The aim of the prospective study was to ascertain whether, in our routine clinical practice, a correlation could be shown between clinical and bronchoscopic diagnosis. The outcome of the study could support a rationale for introduction of this tool in other centers in Poland. In the period between 1 October 2001 and 30 June 2004, of the 1247 burn patients, that were hospitalized in our centre and admitted directly after burn, N=292 patients (59 women and 233 men) were included in the study. For clinical diagnosis, a clinical pathway was used, which includes a questionnaire probing for signs and symptoms of inhalation trauma. When on initial assessment there was a suspicion of inhalation trauma (>3/11 points), a prompt fibreoptic bronchoscopy was performed. Diagnoses of an inhalation burn was confirmed in 261/292 patients, of whom upon initial assessment an inhalation trauma was suspected. Clinical assessment showed that 62/261 scored 5/11, 57/261 scored 6/11, 122/261 had a score of 7/11 and 20/261 scored >7/11. In this group an upper respiratory tract burn was diagnosed in 111/261 cases, damage of the main respiratory tract in 130/261 cases, and an inhalation trauma of the lower respiratory tract was confirmed in 20/261 cases. Based on our findings we concluded that fibreoptic bronchoscopy was shown to be a useful method in our routine clinical practice to confirm diagnosis and treatment of inhalation burns. The high agreement between the clinical suspicion of inhalation injury and the incidence confirmed by bronchoscopy and biopsies, suggest that the clinical indicators we use are reliable. We noted that performing fibreoptic bronchoscopy in patients with acute breathing insufficiency, who are intubated and require high concentrations of oxygen, is not recommended.

Role of the wet-to-dry phase of cleansing in preparing the chronic wound bed for dressing application.

The wet-to-dry phase is a method of cleansing that acts as an alternative to rinsing prior to the application of a modern wound dressing. Debris, exudate and pathogens are removed from the wound, reducing itching and inflammation.

Developing a tool to diagnose cases of necrotising fasciitis.

The rising incidence and high mortality of this soft-tissue disease means it is vital to make a speedy diagnosis. The study described in this paper set out to develop a protocol to aid clinicians to make a rapid diagnosis and initiate prompt treatment.

Measurement of breast skin viscoelasticity and a pilot study on the potential radioprotective effect of a zinc-based cream.

Radiation-induced late skin effects were studied in patients with breast cancer in relation to different protocols of fractionated radiotherapy in three different medical centres, in Israel, the UK and the USA. The mechanical properties of skin were evaluated in breasts of healthy volunteers, and non-irradiated and irradiated breasts of patients, using a newly developed viscoelasticity skin analyser (VESA). The increase of the dose of radiation per fraction was found to have more impact on the development of radiation-induced late skin effects than the elevation of the total dose given. In addition, a pilot study on the possible radioprotective effect of external application of a cream containing zinc oxide on radiation-induced early skin changes in patients with breast cancer was initiated. Non-invasive measurement of trace elements and zinc pharmacokinetics in the skin of healthy controls following the application of the zinc oxide cream were performed by unique diagnostic X-ray spectrometry (DXS). Application of the cream, followed by thorough skin cleansing, significantly increased the amount of residual zinc in the skin, but continuous daily treatment did not cause further build-up of the dermal zinc level. The radioprotective effect of the zinc oxide cream on the skin is now being studied.

Comparison of two dressings in the management of partial-thickness donor sites.

This study evaluated and compared the performance of an adhesive hydro-cellular dressing with that of a paraffin gauze dressing in the treatment of partial-thickness skin-graft donor site wounds. Fifty patients were included in the study, each acting as his/her own control. Donor site area ranged from 20 cm2 to 71 cm2; half the area of each patient's donor site was treated with the trial dressing, the other half with paraffin gauze. Outcome measures assessed were: time to complete epithelialisation; ease of dressing removal; pain on removal; and appearance of the wound bed. The trial dressing demonstrated a significantly faster healing time (p < 10(-6)) and enhanced patient comfort.

Randomized controlled single center study comparing a polyhexanide containing bio-cellulose dressing with silver sulfadiazine cream in partial-thickness dermal burns.

OBJECTIVE: A prospective, randomized, controlled single center study was designed to evaluate clinical efficacy of a polyhexanide containing bio-cellulose dressing (group B) compared to a silver-sulfadiazine cream (group A) in sixty partial-thickness burn patients. PATIENTS AND METHODS: Local ethics committee approval was obtained and patients consented. Parameters were: pain reduction (VAS), healing time and wound bed condition, comparing day 0 (start) versus day 14 (end), as well as, ease of dressing use and treatment costs. RESULTS: All completed the study (n=30/n=30) and were included in the ITT analysis, with a total of 72 burns (group A: n=38, group B: n=34). We noted no differences in healing time. Pain reduction was significantly faster and better in group B (p<0.01). There were fewer dressing changes in group B, compared to group A. Ease of use for the bio-cellulose dressing was rated better compared to group A. In group B, € 95.20 was saved for a 10 day treatment period, compared to group A. CONCLUSION: Group B demonstrated a better and faster pain reduction in the treated partial-thickness burns, compared to group A. The results indicate the polyhexanide containing bio-cellulose dressing to be a safe and cost effective treatment for partial-thickness burns.