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Clinical Investigation to Evaluate the Safety and Efficacy of Dressing CONNETTIVINA HI TECH in the Management of Superficial Cutaneous Lesions

NCT04652752 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-10-18

No results posted yet for this study

Summary

This is an open, single arm, prospective clinical investigation to evaluate the performance of CONNETTIVINA HI TECH, in terms of safety and efficacy in the management of superficial cutaneous lesions. The study will be conducted in one center, in Italy and will enroll 50 subjects . Subjects will be followed until confirmation of complete wound closure, and for a maximum of 26 days, with a follow up of 4 days after re-epithelization will be confirmed.

Conditions

  • Superficial Cutaneous Lesions

Interventions

DEVICE

CONNETTIVINA HI TECH patch

It is a medical device for topical application in the form of a patch with adhesive transparent polyurethane edge and a central pad impregnated with a solution of hyaluronic acid sodium salt, able to create a hydrating environment, such as to favor the natural healing process of tissue repair in case of bruises, abrasions, small cuts, superficial wounds, burns

Sponsors & Collaborators

  • Fidia Farmaceutici s.p.a.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-12
Primary Completion
2022-03-31
Completion
2022-12-30

Countries

  • Italy

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 NCT04652752 on ClinicalTrials.gov