Efficacy and Tolerance of URGO AWC_008 and URGO AWC_022 Dressings (EXPANSION) (NCT05772507) | Clinical Trial Compass
UnknownNot Applicable
Efficacy and Tolerance of URGO AWC_008 and URGO AWC_022 Dressings (EXPANSION)
France85 participantsStarted 2023-08-22
Plain-language summary
Evaluation of the efficacy (wound epithelialization and time to closure) and tolerance (emergence and nature of adverse event) of the new URGO AWC\_008 and URGO AWC\_022 dressings in local management of acute and chronic wounds at risk of local infection or with clinical signs of local infection
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria :
Related to all wounds :
* Adult patient having given free, informed and written consent
* Patient affiliated to a social security insurance scheme (applicable For France),
* Inpatient or outpatient who can be followed by the same investigative team throughout the investigation,
* Acute wound (burn, traumatic wound, unstitched surgical wound) or chronic wound (leg ulcer, pressure ulcer, diabetic foot ulcer),
* Wound whose surface can be covered by a single dressing,
* Wound at least 3 cm from any edge of another wound.
Related to acute wounds, leg ulcer, pressure ulcer:
Patient whose studied wound presents a risk of local infection (based on modified W.A.R. score ≥ 3 points) or with at least 3 of the following clinical signs:
* Pain (spontaneous, pressure pain or increased pain),
* Peri-wound erythema,
* Oedema, induration or swelling,
* Odour (increase, change),
* Exudate (colour modification or increase of exudate),
* Local warmth,
* Hypergranulation,
* Bleeding, friable granulation tissue,
* Stagnant healing/wound deterioration.
Related to diabetic foot ulcer :
Patient whose studied wound presents a risk of local infection (based on modified W.A.R. score ≥ 3 points) or with at least 2 of the following clinical signs:
* Pain (spontaneous, pressure pain or increased pain),
* Peri-wound erythema between 0.5-2.0 cm around the wound,
* Oedema, induration or swelling,
* Odour (increase, change),
* Exudate (colour modification or increase of exudate),
…