Study to Evaluate the Effectiveness of a Medical Device Based on Hyaluronic Acid in Wounds (WOUND-H)

Randomized Controlled Study to Evaluate the Performance and Safety of a Linear Hyaluronic Acid-based Medical Device in the Treatment of Wounds

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Healing Disorder
• Intervention / Treatment: Device: NOVA.EMOSTOP RE-EPITHELIZING

Detailed Description

Wound healing is a complex and dynamic process, which is still far from being fully understood. Wounds can be classified based on different characteristics such as the triggering factor, exposure to the external environment, depth of the wound, healing time period, potential risk of infections1. Two main processes are involved in wound healing: regeneration and repair. Regeneration involves the activation of stem cells capable of reconstituting the integrity of the tissue which will be indistinguishable from the tissue before the injury. Many strategies and products have been proposed in order to improve wound healing, reduce pain and morbidity for patients such as wound dressing, growth factors, skin substitutes, collagen dressing, topical insulin , the antioxidant, the hyperbaric chamber, etc. Hyaluronic acid (HA) was discovered in 1934 by Meyer and Palmer in bovine ocular vitreous. It is a naturally occurring glycosaminoglycan that, by virtue of its viscosity, elasticity and other rheological properties, acts as an ocular lubricant and as a lubricating and shock-absorbing fluid in the joints. It is produced by fibroblasts within the cell membrane and then released into the extracellular space. Inside the skin, it plays an important role in hydrating the extracellular space; constitutes a matrix to support the normal functions of cells; it also has functions in space filling, lubrication, wound healing, modulation of inflammatory cells, and scavenging of free radicals. Due to its remarkable biomedical and tissue regeneration potential, HA is widely used in the treatment of wounds under different formulations such as gauzes, creams and gels4, showing significant clinical results.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco Daniele, PI; Phone Number: 0957631997; Email: marcodaniele@email.it
• Study Contact Backup: Name: Salvotore Balsamo; Phone Number: 0957631997; Email: sbalsamo1@hotmail.it

Study Locations

• Italy
  • Catania
    • Acireale, Catania, Italy, 95024
      • Recruiting
      • Casa di cura riabilitativa Villa Sofia
      • Contact: Marco Daniele, PI; Phone Number: 0957631997; Email: marcodaniele@email.it
      • Sub-Investigator: Salvatore Balsamo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WOUND-H; STUDY FOR THE ASSESSMENT OF THE EFFECTIVENESS OF A MEDICAL DEVICE BASED ON HYALURONIC ACID IN WOUNDS	Device: NOVA.EMOSTOP RE-EPITHELIZING; RE-EPITHELIZING GEL BASED ON HYALURONIC ACID
Active Comparator: Braccio controllo; NORMAL STANDARD THERAPIES FOR WOUND TREATMENT (CLEANING AND DISINFECTION)	Device: NOVA.EMOSTOP RE-EPITHELIZING; RE-EPITHELIZING GEL BASED ON HYALURONIC ACID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement in Clinical Healing score at visit 3	improvement in Clinical Healing score at visit 3	30 days

Collaborators and Investigators

• Sponsor: Nova Argentia S.r.l.
• Investigators: Study Chair: Loredana Comito, Monitor, Clinical Research Consulting S.r.l.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: NA-01-23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No