A wound, i.e., a break in the skin, can result from several reasons. Pressure ulcers (also called pressure sores, bed sores and decubitus ulcers) are localized damage to the skin and underlying soft tissue usually over a bony prominence or related to a medical or other device, occurring as a result of intense and/or prolonged pressure or pressure in combination with shear. Burn wounds result from traumatic injuries to the skin or other tissues primarily caused by heat, electrical discharge, friction, chemicals, or radiation. Burns are acute wounds caused by an isolated, non-recurring insult. The Medical Device Argogen® (adsorbing spray powder for exudates with silver ions) consists of silver zeolite powder, combining in a single physical form the adsorbing properties of the zeolite structure and the antimicrobial properties of silver. Its action is due to the porous structure of zeolite that actively absorbs and control wounds exudate, keeping clean and dry the environment of small skin lesions, as wounds, abrasions, minor burns and bedsores. The association with silver ions gives to the medical device the additional property of an antimicrobial effect. The present study is to confirm that in a population of men and women presenting minor burn wounds (superficial or superficial / deep partial thickness) or chronic pressure ulcers stage 2 or 3 - NPUAP Classification (partial-thickness skin loss with exposed dermis or full-thickness skin loss) the medical device already CE marked Argogen® (adsorbing spray powder for exudates with silver ions) safely attests its capacity to promote wound healing, evaluated as percentage (%) of subjects with objective signs of wound healing (evaluated by mean of VSS score reduction for burn wounds or PUSH tool score reduction for pressure ulcers), results observed after 2 and 4 weeks after the beginning of the treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
The medical device will be self-administered by each patient twice daily without interruption for the duration of the study (4 weeks) or until complete healing. Application is carried out by spraying at short intervals, lightly pressing the dispenser button and directing the spray onto the area to be treated.
MC Medica SRL
Craiova, Dolj, Romania
SC Salvosan Ciobanca SRL
Zalău, Sălaj County, Romania
To evaluate the overall performance of Argogen spray® in safely promoting wound healing according to following evaluations
of pressure ulcers: percentage of subjects with objective signs of wound healing, assessed through the validated Pressure Ulcer Scale for Healing tool (PUSH ver. 3.0score) evaluated by Investigator and burn wounds: percentage (%) of subjects with objective signs of wound healing, assessed through the validated Vancouver Scar Scale (VSS), evaluated by Investigator.
Time frame: 2 - 4 weeks
To evaluate the overall safety of Argogen spray® in safely promoting wound healing according to following evaluations
Adverse Events, Serious Adverse Events, Adverse Device Events, Serious Adverse Device Events, Anticipated Serious Adverse Device Events, Unanticipated Serious Adverse Device Events incidence assessed by Investigator and reported according to the current legislation.
Time frame: 2 - 4 weeks
Assessment of wound bed, wound edge, periwound skin status, performed by the Investigator
Assessment of wound bed, wound edge, periwound skin status, performed by the Investigator at 2 and 4 weeks after the initiation of treatment, compared to day 0 (baseline), based on skin appearance. The lower the percentage and affected surface - cm, the better evolution of healing compared to baseline.
Time frame: 2 - 4 weeks
Time to healing evaluated by the Investigator
The investigator will assess the time of healing
Time frame: 2 - 4 weeks
Pain assessment assessed by the Subject
Evaluation of pain due to burn wound or pressure ulcer will be done according to a Visual Analogue Scale. The rating will be made on 100 mm line/scale in which 0 is meaning no pain and 100 is meaning very severe pain. The subject has to place a vertical mark on a 100mm line to indicate how bad does he/she feels the pain at the moment of completing the questionnaire.
Time frame: 2 - 4 weeks
To assess the subject satisfaction with the treatment
The subject will assess the satisfaction with the treatment by means of the treatment satisfaction questionnaire using the four-point scale in which the subject has to place an "X" mark in the box that fits with his/ her situation: Very Satisfied, Satisfied, Moderately satisfied, Not satisfied.
Time frame: 2 - 4 weeks
To evaluate the global performance of Argogen
To evaluate the global performance of Argogen® by means of the Investigator Global Assessment of Performance, assessed by Investigator, through photos taken at each visit and by the performance of the treatment questionnaire using a 4-point scale: * 1= very good performance * 2 = good performance * 3 = moderate performance * 4 = poor performance
Time frame: 2 - 4 weeks
To evaluate the global safety of Argogen
To evaluate the global safety of Argogen® by means of the Investigator / Patient Global Assessment of Safety assessed by the Investigator and by the patient using a 4-point scale: * 1= very good safety * 2 = good safety * 3 = moderate safety * 4 = poor safety
Time frame: 2 - 4 weeks
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