Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT04936204
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent.
* Male or female ≥ 18 years
* Having wounds (both chronic or acute wounds regardless of etiology), with the following characteristics:
* Non infected
* Wound Bed Score ≥4 and \<13
* Wound area ≤ 100 cm2
* Patient having one or more factors associated with increased risk of wound infection (IWII, 2016)
* Patient able to read and understand the language and content of the study material, understand the requirements for follow-up visits, is willing to provide information at the scheduled evaluations and is willing, able and ensuring to comply with the study requirements for the whole study period.
Exclusion Criteria:
* Absence of factors associated with increased risk of wound infection
* Infected wounds - where infection is defined by:
For chronic wounds:
A combination of three or more signs or symptoms of local infection: periwound skin erythema, local heat, persistent pain, oedema of wound.s edge, malodour, pus and heavy exudation (Cutting KF, 1994; Trial C, 2010);
For acute wounds:
Cellulitis or pus or abscess, Delayed healing, erythema, hardening of edge, serous-purulent drainage, malodour
* Non-vital tissue greater than 25% of the total wound area
* Heavily exuding wounds
* Presence of fistula
* History of connective tissue disease, e.g., systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
* Active malignant disease
* Active sickle cell disease
* radiation therapy
* Known allergy to any of the devices' constituents
* Pregnant and breastfeeding women
* Subjects unable to understand informed consent or having a high probability of non- compliance with the study procedures and or non-completion of the study according to investigator's judgement.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04936204
Study Brief:
Protocol Section:
NCT04936204