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.

OBJECTIVE: 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). METHOD: 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. RESULTS: 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). CONCLUSION: There was no difference between the dressings evaluated. The presence of Pseudomonas aeruginosa significantly impaired wound healing.