Clinical Performance and Safety of Cerviron Vaginal Ovules in the Management of Cervical Lesions Postoperative Care: A National, Multicentric Study

BackgroundLaser conization and electrocautery are the preferred surgical options for the management of benign cervical erosions. Local re-epithelialization therapy should be initiated preoperatively and postoperatively to prevent severe bleeding, wound inflammation, and infection. ObjectiveTo investigate the aspect of the cervix by colposcopy after a 3-month treatment with the medical device. As secondary objectives, the study analyzed the presence of primary and secondary inflammation, the presence of ulceration, colpitis, vaginal discharge, and vaginal irritation. MethodsThe study population included 27 participants with benign, ectopic, cervical ectopy that consented their participation in 3 research sites from Romania. The treatment protocol consisted of the delivery of the medical device intravaginally, for 15 consecutive days, with a total study duration of 3 months. ResultsCerviron had a positive impact on cervical epithelialization. After 3 months of treatment with Cerviron, for 100.00% of the participants, the colposcopy result was normal. Cerviron seems to exert a beneficial effect in reducing primary inflammation correlated with cervical erosions. It was observed that after 90 days of treatment primary inflammation was reduced by 85.19% (p < 0.001; 95% CI [58.74 - 98.35]). Other clinical parameters associated with cervical ectopy have certainly improved: vaginal erosion by 70.37% (p < 0.001, 95% CI [48.30 - 93.23]), ulceration by 55.56% (p < 0.001, 95% CI [33.22 - 83.67]), colpitis by 81.48% (95% CI [62.52 - 100.00], and vaginal secretion by 66.67% (95% CI [44.26 - 90.74]). ConclusionsThe medical device reduced inflammation and other symptoms related to non-malignant cervical disease. Moreover, our study findings suggest that supportive treatment with Cerviron can be recommended for cervical wound healing in patients with human papillomavirus infection. ClinicalTrials.gov identifier: NCT04735718