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Study to Evaluate the Effectiveness of a Medical Device Based on Hyaluronic Acid in Wounds

NCT06284538 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-02-29

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the safety and performance of a Class IIB medical device based on linear hyaluronic acid used in the treatment of post-surgical wounds. The outcomes of the study are the improvement of wound healing assessed through the Clinical Healing score (score from 0 to 5), which includes the evaluation of: redness, edema, suppuration, healthy granulation tissue and signs of re-epithelialization; the percentage of patients with completely healed wounds at day 30 post-treatment; the pain perceived by the patient when changing the dressing; the frequency of adverse events.

Conditions

  • Wound Healing Disorder

Interventions

DEVICE

NOVA.EMOSTOP RE-EPITHELIZING

RE-EPITHELIZING GEL BASED ON HYALURONIC ACID

Sponsors & Collaborators

  • Nova Argentia S.r.l.

    lead INDUSTRY

Principal Investigators

  • Loredana Comito, Monitor · Clinical Research Consulting S.r.l.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2024-07-31
Completion
2024-09-30

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 NCT06284538 on ClinicalTrials.gov