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

Abstract

Background Laser 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. Objective To investigate the aspect of the cervix by colposcopy after a 3-month treatment with the medical device As secondary objectives, the study analyzed other clinical parameters, such as the presence of primary and secondary inflammation, the presence of ulceration, colpitis, vaginal discharge, and vaginal irritation. Methods The study population included 27 participants with benign, ectopic, cervical ectopy, with or without an associated human papillomavirus infection. The study design included 4 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. Results Cerviron 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%. Other clinical parameters associated with cervical ectopy have certainly improved: vaginal erosion by 70.37%, ulceration by 55.56, colpitis by 81.48%, and vaginal secretion by 66.67%. Conclusions The 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 Keywords: cervical ectopy, postoperative care, cervical epithelialization, human papillomavirus, medical device, cervical polyps, cervical hypertrophy.

Competing Interest Statement

R.P. and R.M.S. are currently employed at MDX Research. A.R.P. provided statistical input while working for MDX Research. MDX Research was involved in the study design, site selection, collection, statistical analysis, and preparation of the manuscript. The authors have indicated that they have no other conflicts of interest regarding the content of this article.

Clinical Trial

NCT04735718

Funding Statement

Perfect Care Distribution provided financial support for the clinical investigation. However, Perfect Care Distribution had no involvement in the study design; collection, analysis, and interpretation of data; writing of the report; and the decision to submit the article for publication.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethics Committee /IRB of CNBMDM (National Ethics Committee from Romania) gave ethical approval of this work.

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