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

NCT06284538 | Recruiting

• 1 other identifier: NA-01-23
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• improvement in Clinical Healing score at visit 3

  improvement in Clinical Healing score at visit 3

  30 days

Study Arms (2)

WOUND-H

EXPERIMENTAL

STUDY FOR THE ASSESSMENT OF THE EFFECTIVENESS OF A MEDICAL DEVICE BASED ON HYALURONIC ACID IN WOUNDS

Device: NOVA.EMOSTOP RE-EPITHELIZING

Braccio controllo

ACTIVE COMPARATOR

NORMAL STANDARD THERAPIES FOR WOUND TREATMENT (CLEANING AND DISINFECTION)

Device: NOVA.EMOSTOP RE-EPITHELIZING

Interventions

NOVA.EMOSTOP RE-EPITHELIZING DEVICE

RE-EPITHELIZING GEL BASED ON HYALURONIC ACID

Braccio controllo; WOUND-H

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients with post-surgical wounds
• subjects capable of complying with the protocol procedures
• signing of informed consent

You may not qualify if:

• Pregnancy or breastfeeding
• inadequate contraceptive procedures in fertile women
• chronic concomitant treatment with local antiseptics, use of anti-inflammatory drugs (steroids and non-steroids), analgesics, antineoplastics or immunosuppressants
• non-therapeutic use of psychoactive substances, drug and/or alcohol abuse
• immunodeficiencies (including HIV infection)
• Oncology patients;
• known allergies, hypersensitivity or intolerance to any of the substances administered in this study
• any medical or non-medical condition that may significantly reduce the possibility of obtaining reliable data and achieving the objectives of the study
• Participation in clinical trials with devices or drugs within 3 months prior to the screening visit.

Sponsors & Collaborators

• Nova Argentia S.r.l.: lead

Study Sites (1)

Casa di cura riabilitativa Villa Sofia

Acireale, Catania, 95024, Italy

RECRUITING

Study Officials

• Loredana Comito, Monitor

  Clinical Research Consulting S.r.l.

  STUDY CHAIR

Central Study Contacts

Marco Daniele, PI

CONTACT

0957631997; marcodaniele@email.it

Salvotore Balsamo

CONTACT

0957631997; sbalsamo1@hotmail.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 29, 2024
• Study Start: January 15, 2024
• Primary Completion: July 31, 2024
• Study Completion: September 30, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

IT (1)