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. Declaration of interest: This study was supported by a grant from Laboratoires Urgo. EB, UM, LT and SB are employees of Laboratoires Urgo. SL, AG, MD, CL and JD provide 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, Bad Durkheim, Germany.