Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284538
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-02-13
Brief Title:
Study to Evaluate the Effectiveness of a Medical Device Based on Hyaluronic Acid in Wounds
Sponsor:
Nova Argentia Srl
Organization:
Nova Argentia Srl
Study Overview
Official Title:
Randomized Controlled Study to Evaluate the Performance and Safety of a Linear Hyaluronic Acid-based Medical Device in the Treatment of Wounds
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WOUND-H
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None