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. 2023 Jul 7;19(2):54.
doi: 10.3892/br.2023.1618. eCollection 2023 Aug.

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

Izabella Petre  1   2 , Daniela Teodora Sirbu  3 , Ramona Petrita  4 , Andreea-Denisa Toma  5 , Ema Peta  6 , Florentina Dimcevici-Poesina  6
Affiliations

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

Izabella Petre et al. Biomed Rep. .

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.

Keywords: cervical lesions; cervical mucosa; cervix re-epithelialization degree; medical device; vaginal bleeding; vaginal pH; vaginal pain.

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Conflict of interest statement

FD-P and EP are employed at Perfect Care Distribution SRL. All the other authors declare no competing interests. The funder Perfect Care Distribution SRL had no role in the design of the study, or in the collection, analyses, or interpretation of data, or in the writing of the manuscript, or in the decision to publish the results.

Figures

Figure 1
Figure 1
Schematic diagram for the present study.
Figure 2
Figure 2
Clinical performance assessed by the investigator by colposcopy.
Figure 3
Figure 3
Changes in vaginal pH throughout the study (90 days).
Figure 4
Figure 4
Evaluation of pain level between the study visits (90 days).
Figure 5
Figure 5
Evaluation of the level of vaginal bleeding throughout the study (90 days).
Figure 6
Figure 6
Likert Scale evaluation at the end of the study.
See this image and copyright information in PMC

References

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