Effectiveness of papain gel in the treatment of venous ulcers: a clinical trial

The study aimed to evaluate the effectiveness of papain gel at 2% compared to the carboxymethylcellulose gel at 2% in the treatment of patients with chronic venous ulcers and analyze sociodemographic, economic and clinical characteristics of these patients, treated at the Outpatient Wound Repair at Antonio Pedro University Hospital/UFF. METHOD: Randomized Controlled Trial (RCT) with 12 weeks of follow-up. The consecutive sample consisted of 18 volunteers and a total of 28 venous ulcers. The data collection occurred from April 2013 to January 2014. The primary end point was the decrease of the lesion area and the secondary endpoints were devitalized tissue decrease in the ulcer bed and the reduction of the amount of exudate. The study was submitted to the Ethics Committee of the Faculty of Medicine, University Hospital Antonio Pedro/UFF and approved with the number 196/98, CAAE n. 0154.0.258.000-08. RESULTS: The groups were homogenous regarding sociodemographic, economic and clinical characteristics. The volunteers ages ranged from 45 to 85 years old, with a mean of 61.94 years old. Most participants declared married (55.6%), with schooling up to elementary school (66.7%), resident of São Gonçalo (44.4%) and retired (66.7%). All volunteers had chronic venous insufficiency, 61.1% had hypertension and 11.1% diabetes mellitus. Most venous ulcers injuries began more than ten years ago (53.6%) and the most affected location was the malleolar area (53.6%). Regarding the ulcers evolution over the 12 weeks of treatment, the papain group showed a significant decrease in the lesions area, especially in the period between the 5th and the 12th weeks of treatment, with two healed ulcers and significant increase in the amount of epithelialization tissue. In both treatment groups, there was a significant decrease in the amount of devitalized tissue and an increase of the granulation tissue from 1st week to the 12th week (p <0.05). CONCLUSION: The papain gel at 2% was more effective in reducing of the lesions area, however it showed similar to the carboxymethylcellulose gel at 2% in reducing the amount of exudate and devitalized tissue. From the results of the research were highlighted the main nursing care that can help the assistance and treatment of patients with chronic venous ulcers