Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06284538
Study type Interventional
Source Nova Argentia S.r.l.
Contact Marco Daniele, PI
Phone 0957631997
Email marcodaniele@email.it
Status Recruiting
Phase N/A
Start date January 15, 2024
Completion date September 30, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05608187 - Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers Phase 2
Completed NCT05101473 - Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study N/A
Completed NCT05098314 - Impact of Personalized Interventions to Raise Teleconsultation Awareness in EHPAD
Recruiting NCT03314350 - Prevalence of Wound Healing Disturbances in Geriatric Inpatients (WONDER Study)
Completed NCT04446767 - Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer N/A
Completed NCT05509673 - Lipofilling for Healing of Chronic Wounds N/A
Not yet recruiting NCT06420323 - NovoX®Cup as Primary Dressing After Breast Reduction
Completed NCT03720119 - Multicentre Observational Study on the Wound Pain Relief Properties of ORTODERMINA®
Completed NCT01528033 - Treatment Study of Vacuum Assisted Closure for Postsurgical Subcutaneous Abdominal Wound Healing Impairments N/A
Completed NCT06371430 - Bone Bioactive Liquid Efficiency in Improving Dental Implant Osteointegration Oral Soft Tissue Hellingand Oral Surgery N/A