TLC-Ag dressings: a prospective, multicentre study on 728 patients with wounds at risk of or with local infection.

OBJECTIVE: This study aimed to evaluate the management of an unselected cohort of patients with wounds at risk of or with clinical signs of local infection, treated with two antimicrobial contact layers impregnated with silver (TLC-Ag healing matrix), under real-life conditions during the COVID-19 pandemic. METHOD: A large, prospective, multicentre, observational study with two TLC-Ag dressings (UrgoTul Ag/Silver and UrgoTul Ag Lite Border, Laboratoires Urgo, France) was conducted in Germany between May 2020 and May 2021. The main outcomes included a description of the treated patients and their wound management, the changes in wound infection and wound healing outcomes over a maximum period of four weeks of treatment, as well as the overall clinical assessment of the performance, local tolerance and acceptability of dressings. RESULTS: A total of 728 patients with wounds of various aetiologies and wound infection status were treated with the evaluated dressings in 39 centres for a mean duration of 26±19 days, with an intermediate visit conducted in 712 (97.8%) patients after a mean period of 12±9 days. At the initial visit, it was established that the majority of patients (60.4%) had a wound infection, while the remaining cohort presented first clinical signs of a local wound infection (25.1%) or were at risk of wound infection (13.2%) (unclear status in 1.2%). Throughout the study period, all the parameters of wound infection continuously decreased, resulting at the final visit in a reduction by 78.9% of the prevalence of local wound infections and by 72.0% of the clinical signs of wound infection, the most rapidly diminished clinical sign being wound deterioration. Concurrently, in terms of the healing process, 92.1% of the wounds healed or improved, 3.2% remained unchanged and 1.7% worsened (data missing for 3.0%), and an improvement of the periwound skin was reported in 65.7% of the patients. Overall, the two dressings were 'very well accepted' by the majority of patients, with no uncomfortable feeling at wearing and no pain at dressing removal, and were assessed by the physicians as 'very useful' in the majority of the cases with a 'very good' efficacy in terms of antimicrobial activity and promotion of the wound healing process. Similar results were reported regardless of the wound type treated or of the TLC-Ag dressing evaluated. CONCLUSION: These results are consistent with previous clinical evidence on TLC-Ag dressings. They support the good efficacy, good tolerability and usefulness of these antimicrobial dressings in the management of patients with wounds at risk or with clinical signs of local infection, in association with appropriate standard of care.

[Sucrose octasulfate-evidence in the treatment of chronic wounds]. / Sucrose Octasulfat ­ Evidenz in der Behandlung chronischer Wunden.

Patients with chronic wounds should receive wound treatment in addition to causative therapy. In this context, the lack of adequate evidence for wound healing products has been repeatedly discussed. Using the example of TLC-sucrose octasulfate (TLC: technology lipido-colloid), the present review shows that there is significant data with good evidence and comparability in this area. One therapeutic approach to promote wound healing is the inhibition of matrix-metalloproteinases, for example by sucrose octasulfate. For wound products containing TLC-sucrose octasulfate, several sequential clinical studies have been conducted in recent years. The WHAT study was an open randomized controlled trial (RCT) with 117 patients with venous leg ulcers (VLU). The CHALLENGE study was a double-blind RCT with 187 patients with VLU. The SPID study was a pilot study with 33 patients with diabetic foot ulcers (DFU). The two prospective, multicenter clinical pilot studies NEREIDES and CASSIOPEE examined a total of 88 patients with VLU in different phases of healing. In the REALITY study, a pooled data analysis was performed on eight observational studies with 10,220 patients with chronic wounds of different genesis. In the double-blind, two-armed EXPLORER RCT, 240 patients with neuro-ischemic DFU were followed from first presentation until complete healing. In all studies, a significant promotion of wound healing could be shown by the use of wound healing products with TLC-sucrose octasulfate.

Clinical evaluation of polyabsorbent TLC-NOSF dressings on chronic wounds: a prospective, observational, multicentre study of 1140 patients.

OBJECTIVE: The superior wound healing properties and cost-effectiveness of TLC-NOSF dressings in the local treatment of chronic wounds have already been demonstrated by several randomised controlled trials (RCTs) at a high quality level. Therefore, this study aimed to evaluate the efficacy and safety of new TLC-NOSF dressings with polyabsorbent fibres in an unselected population of patients under real-life conditions. METHOD: A large, prospective, multicentre, observational study with two polyabsorbent TLC-NOSF dressings (UrgoStart Plus Pad and UrgoStart Plus Border, Laboratoires Urgo, France) was conducted in Germany between July 2017 and December 2018. Main outcomes included wound healing rate, clinical assessment of wound healing progression, local tolerability and acceptance of dressings. RESULTS: A total of 1140 patients with chronic wounds of various aetiologies (leg ulcers, diabetic foot ulcers, pressure ulcers, etc.) were treated with the investigated dressings in 130 centres, for a mean duration of 56±34 days. By the final visit, 48.5% of wounds had healed and 44.8% had improved. Similar results were reported regardless of wound aetiology or regardless of proportions of sloughy and granulation tissue at the start of treatment. According to the subgroup analysis by wound duration, the sooner the TLC-NOSF treatment was initiated, the better the clinical outcomes for all types of wounds. The dressings were very well tolerated and accepted by the patients. CONCLUSION: These results are consistent with those from RCTs conducted on TLC-NOSF dressings. They complete the evidence on the good healing properties and safety profile of these dressings, especially in non-selected patients treated in current practice, and regardless of the characteristics of wounds and patients. They support the use of the dressings as a first-line intervention and until wound healing in the management of chronic wounds, in association with appropriate standard of care.

Use of a TLC-Ag dressing on 2270 patients with wounds at risk or with signs of local infection: an observational study.

OBJECTIVE: A description of wounds treated with a poly-absorbent silver dressing (with technology lipido-colloid with silver ions, TLC-Ag), and evaluation of the short-term clinical impact of the dressing on the wound healing process, under real-life conditions. METHOD: A large, prospective, multicentre, observational study of patients in 81 centres in Germany, presenting with an exuding wound at risk or with clinical signs of local infection for whom the evaluated TLC-Ag dressing (UrgoClean Ag, Laboratoires Urgo, France) has been prescribed. Main outcomes included: reduction in number of wound infections diagnosed and clinical signs of local infection, wound healing rate, clinical assessment of wound healing progression, relative wound area reduction (RWAR), local tolerability, handling and acceptance of the dressing. RESULTS: A total of 2270 patients with acute and chronic wounds of various aetiologies were treated with the evaluated dressing for a mean duration of 22±13 days. All clinical signs of local infection and the diagnosed wound infections were substantially reduced at two weeks after the treatment initiation. All wound infection parameters continued to reduce until the last visit. In the meantime, clinical improvement in wound healing was reported in 98.9% of acute wounds, with a wound closure rate of 68.5%. In chronic wounds, a median RWAR of 57.4% was achieved, with an improvement in healing process documented by clinicians in 90.6% of cases, stabilisation in 6.1% and worsening in 3.2%. Similar results were reported, regardless of exudate level and proportion of sloughy and granulation tissues in the wound bed at baseline. The dressing was well tolerated and well accepted by both patients and health professionals. CONCLUSION: These results, documented in a large cohort of patients treated in current practice, support and complete the clinical evidence on the healing properties and safety profile of the TLC-Ag dressing in the management of wounds at risk or with clinical signs of local infection, regardless of wound and patient characteristics. Declaration of interest: This study was supported by a grant from Laboratoires Urgo. UM, EB, LT and SB are employees of Laboratoires Urgo. JD, KCM and MD provided advisory and speaking services to pharmaceutical and other healthcare organisations including, but not limited to, Laboratoires Urgo. Data management and statistical analyses were conducted independently by INPADS GmbH, Germany.

Efficacy of MMP-inhibiting wound dressings in the treatment of chronic wounds: a systematic review.

OBJECTIVE: Matrix metalloproteinases (MMPs) substantially contribute to the development of chronicity in wounds. Thus, MMP-inhibiting dressings may support healing. A systematic review was performed to determine the existing evidence base for the treatment of hard-to-heal wounds with these dressings. METHODS: A systematic literature search in databases and clinical trial registers was conducted to identify randomised controlled trials (RCTs) investigating the efficacy of MMP-inhibiting dressings. Studies were analysed regarding their quality and clinical evidence. RESULTS: Of 721 hits, 16 relevant studies were assessed. There were 13 studies performed with collagen and three with technology lipido-colloid nano oligosaccharide factor (TLC-NOSF) dressings. Indications included diabetic foot ulcers, venous leg ulcers, pressure ulcers or wounds of mixed origin. Patient-relevant endpoints comprised wound size reduction, complete wound closure, healing time and rate. Considerable differences in the quality and subsequent clinical evidence exist between the studies identified. Substantial evidence for significant improvement in healing was identified only for some dressings. CONCLUSION: Evidence for the superiority of some MMP-inhibiting wound dressings exists regarding wound closure, wound size reduction, healing time and healing rate. More research is required to substantiate the existing evidence for different types of hard-to-heal wounds and to generate evidence for some of the different types of MMP-inhibiting wound dressings.

Treatment with a potassium-iron-phosphate-citrate complex improves PSE scores and quality of life in patients with minimal hepatic encephalopathy: a multicenter, randomized, placebo-controlled, double-blind clinical trial.

OBJECTIVE: Minimal hepatic encephalopathy (MHE) is one of the possible complications of liver cirrhosis. In this study, a potassium-iron-phosphate-citrate complex was analyzed for its efficacy and safety in the treatment of MHE, as this complex is supposed to bind to the major pathogenic factor of MHE: intestinal ammonia. MATERIALS AND METHODS: In this placebo-controlled, double-blind clinical trial, 51 patients with MHE were randomized into two groups at a ratio of 1 : 1 and treated for 4 weeks either with a potassium-iron-phosphate-citrate complex or a placebo. The efficacy of treatment was assessed according to changes in the portosystemic encephalopathy (PSE) score. Further assessments included alterations in quality of life and safety evaluations. RESULTS: Significantly more patients showed improvements in the PSE syndrome test from pathological to nonpathological PSE scores in the potassium-iron-phosphate-citrate-treated group (72.0%) than in the placebo group (26.9%; P=0.0014). Furthermore, quality of life improved at a higher grade in the verum group (by 0.7 ± 0.6 U) compared with the placebo group (by 0.2 ± 0.6 U; P=0.0036). Adverse events occurring in 28.0% of potassium-iron-phosphate-citrate-treated patients were generally mild or moderate and affected mainly the gastrointestinal tract. CONCLUSION: Treatment with potassium-iron-phosphate-citrate significantly improved PSE scores and quality of life in patients with MHE. The potassium-iron-phosphate-citrate complex is a well-tolerated treatment option in MHE.