A Topical Agent Based on Recombinant Human Epidermal Growth Factor and Silver Sulfadiazine Accelerates the Healing of Venous (Chronic) Ulcers: A Prospective Comparative Non-Randomized Study ESKIZ

Treatment of venous stasis ulcer is challenging. Data on the use of topical agents to promote wound healing are extremely limited. The objective of the study was to evaluate the effectiveness of a topical agent based on recombinant human epidermal growth factor and silver sulfadiazine in accelerating the healing of venous stasis (chronic) ulcers. Materials and methods. A prospective, comparative, non-randomized study was conducted, including 180 patients with venous stasis ulcers. Wound coverings and compression therapy were used in all patients. In the test group, the studied agent was applied to the ulcer under the wound covering; in the control group, topical ointments/gels were not used. Results. The studied agent provided the best outcome for ulcer reduction. The relative decrease in area (% of baseline) after 1 month of follow-up was (Me [Q1; Q3]) –43.3% [–59.2; –29.9] and –36.2% [–52.0; –21.0] (p=0.021) in the study and control groups, respectively. The absolute change in area (cm2) after 1 month was –2.1 [–4.4; –1.1] and –1.0 [–2.1; –0.2] (p≤0.001), and after 2 months, –4.2 [–6.8; –2.9] and –2.2 [–4.3; –0.8] (p≤0.001), respectively. The proportion of patients with a fully healed ulcer, re-weighted by the initial ulcer area, was 2.3% and 0.4% (p=0.025) at 1 month, and 39.4% and 27.6% (p≤0.001) at 2 months, respectively. For ulcers with an initial area of more than 5 cm2, the relative decrease in area (% of the initial area) at 1 month was –49.1% [–60.0; –40.0] and –30.5% [–40.0; –20.0] (p≤0.001), respectively, and the absolute decrease (cm2) was –4.3 [–6.4; –2.7] and –2.8 [–3.4; –1.6] (p≤0.001), respectively. In patients with varicose veins, no differences were found between the groups in the relative decrease in the area of ulcers after 1 month (p=0.256), but differences were found in the absolute change in area (cm2): –2.1 [–4.7; –1.1] and –0.7 [–1.3; –0.2] (p≤0.001), respectively. Conclusions. A topical agent based on recombinant human epidermal growth factor and silver sulfadiazine accelerates the healing of venous stasis (chronic) ulcers.