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Clinical Research
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The CONTOP study: a large-scale, comparative, randomized study in patients treated with a sustained silver-releasing foam dressing Munter KC, Beele H, Russell L, Basse PB, Groechenig E, Crespi A, Fraulin F, Rucigaj TP Introduction: Large-scale comparative studies using real-life study settings add to the evidence base from rigorous clinical studies and may be helpful in treatment decision-making. The aim of this study was to assess clinical performance, cost-effectiveness and quality of life of a sustained silver-releasing foam dressing (treatment A) versus "local best practiceÓ (treatment B) in the treatment of ulcers with delayed healing. Methods: This comparative, open, prospective, and block-randomized study includes patients from numerous European woundcare clinics. Main ulcer types included leg, pressure, and diabetic foot ulcers. Inclusion/Exclusion criteria were limited to obtain real-life data. All treatments complied with the products' instructions for use. During a 4-week observation period ulcer area, exudate level, odor, pain, dressing change frequency and ease of use were monitored with 1-week intervals. Results: 619 patients were included. Baseline data were comparable in the two groups and ulcer types were mainly leg ulcers (>70%). Treatment B predominantly comprised of moist-wound healing treatment and a high extent of silver containing dressings. Wound area decreased significantly faster in patients treated with dressing A (50.0% versus 36.6%); progress towards complete healing was achieved to a larger extent (P =0.0001) in group A. Quality of life related aspects (odor and pain) significantly improved with dressing A (P <0.0001). Dressing A was significantly easier to use (P <0.0001). Wear-time was longer for Dressing A (3.1 versus 2.1 days); exudate level improved faster (P=0.006) and exudate handling capabilities were better for dressing A (P <0.0001). Conclusions: Substantial comparative patient data showed Dressing A is more clinically effective than "local best practice", promotes good quality of life as well as being a practical feasible wound management solution due to longer wear-time.Treatment A: Contreet Foam, Coloplast Treatment B: Òlocal best practiceÓ = based on current clinical practice (saline gauze, moist wound healing dressings, dressings containing active components etc.) |
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