Randomized, double-blind clinical trial comparing the healing of stasis ulcers in lower limbs with standard hydrocolloid gel dressings and with dressings with Syzygium cumini extract

To evaluate the healing of venous ulcers in the lower limbs (VLU) using dressings with hydrocolloid gel associated with Syzygium cumini extract (SHG) compared to standard hydrocolloid gel dressings (HG).This prospective, double-blind, randomized trial recruited 90 patients with VLU divided into: dressings with SHG (n = 44) and dressings with HG (n = 46). Primary endpoint was healing in the 14th visit. Secondary endpoints were healing rate, complete healing during follow-up, and improvement in the pain scale and in quality of life.There were no significant between-group differences in healing (p = 0.15). The wound area made healing difficult (p = 0.008). Age, body mass index, and wound time demonstrated a tendency to worsen the healing. Positive culture for Pseudomonas aeruginosa resulted in 88% reduction in the healing risk (p < 0.0001).There was no difference between the dressings evaluated. The presence of Pseudomonas aeruginosa significantly impaired wound healing.