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The Effect of Mucogyne® Gel on Wound Healing

NCT05888194 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2024-03-12

No results posted yet for this study

Summary

The aim of this post-market clinical follow up study is to confirm the efficacy and safety of topical application of Mucogyne® gel in the process of wound healing, when used in accordance with its approved labeling, in the context of postpartum perineal wounds.

Conditions

  • Perineal Tear and Episiotomy

Interventions

DEVICE

Mucogyne® gel

In Mucogyne group, each eligible patient will receive a box of Mucogyne® gel. The patient will apply Mucogyne® gel, 48-hours after delivery, everyday, twice a day, massaging it into the intimate area, for a 10-day period.

Sponsors & Collaborators

  • Biocodex

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-12
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05888194 on ClinicalTrials.gov