Real‑world study of Cerviron^® vaginal ovules in the treatment of cervical lesions of various etiologies

Abstract

Cervical lesions can be caused by pathogens, hormonal changes or by cervical injury. The recommended treatment in all cases is excision. Local re-epithelialization therapy should be initiated preoperatively and postoperatively. The present study assessed the post-market performance and tolerability of Cerviron ® ovules in the treatment and management of cervical lesions postoperatively. The study population included 345 participants aged 20-70 years with either a cervical lesion under treatment or with recent surgical removal of a cervical lesion. The degree of re-epithelialization of the cervical mucosa was improved in 73.17% of the patients evaluated during routine colposcopy exams and 92.73% of patients recorded no bleeding. When adding Cerviron ® either as monotherapy or in association with other antimicrobials in postoperative care of the cervical ectropion, improved postoperative outcomes such as reduced post-interventional bleeding and a superior quality of healing were observed. The study and its details are registered in www.clinicaltrials.gov under ID NCT05668806.

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

“…The study results show that a 45-days treatment (3 treatment sessions of 15 days each) with Cerviron vaginal ovules was beneficial in providing a complete degree of cervical epithelialization and reduced the multitude of vaginal symptoms, including bleeding, inflammation, malodor, dysuria, dyspareunia, pain, and leucorrhea. This result was consistent with previous clinical studies that included the same medical device, NCT04735705, and NCT05668806 [18,19].…”

“…Treatment should be continued for 15 consecutive days. Its adjuvant role in the treatment of non-specific vaginitis was outlined in a recent clinical investigation (NCT04735705) and a real-world study (NCT05668806) revealed its intended use as a treatment for cervical lesions of different etiologies [18][19]. It favors the healing and re-epithelialization processes and reduces the proliferation of endogenous pathogens.…”