Acetic Acid 2% Solution for Skin Ulcers
- Registration Number
- NCT06297967
- Lead Sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Brief Summary
The objective of this clinical trial is to assess the effectiveness of acetic acid in patients suffering from chronic cutaneous ulcers with biofilm. The primary question it seeks to address is whether acetic acid (as a 2% topical solution) is superior to the current standard treatment for chronic cutaneous ulcers with biofilm at our center (Prontosan®).
Participants will be randomly assigned to receive either the acetic acid solution treatment or the standard current treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 104
- Patients over 18 years of age.
- Continued care (hospital or outpatient) in one of the Consorci Sanitari Alt Penedes i Garraf (CSAPG) units.
- Presence of a cutaneous ulcer with biofilm, with an area of less than 120 cm2, and in any location (except the facial region).
- Plan to undergo treatment and follow-up of the lesion (at least 8 weeks) at the study center.
- Ability to cooperate in necessary evaluations.
- Informed consent for inclusion in the study, either from the participant themselves or from their legal representative.
-
Participants diagnosed with any of the following conditions:
- Ulcers with exposed bone tissue.
- Neoplastic-origin ulcers.
- Ulcers lasting more than 18 months.
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Participation in another clinical trial involving an experimental intervention during the period of the current trial and/or establishing a visit frequency incompatible with the current trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Prontosan Topic application of Prontosan® for 15 min, typically administered every 24h. The frequency of the treatments may be modified according to the evolution of the lesion at the discretion of the nurse in charge of the treatments Acetic Acid Acetic Acid Topic application of a Acetic Acid 2% solution for 15 min, typically administered every 24h. The frequency of the treatments may be modified according to the evolution of the lesion at the discretion of the nurse in charge of the treatments
- Primary Outcome Measures
Name Time Method Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment 8 weeks The assessment of the ulcer will include measuring its area through digital planimetry.
- Secondary Outcome Measures
Name Time Method Percentage of participants with ulcer healing at 12 weeks from the start of treatment. 12 weeks The assessment of the ulcer will performed by the nurse responsible for monitoring the ulcer. The ulcer will be considered fully healed when the surface is epithelialized.
Number of adverse reactions associated with the treatment, collected from the medical record. 12 weeks The number of adverse reactions will be evaluated through the review of the participant's medical records by a trained member of the research team.
Percentage of participants with ulcer healing at 4 weeks from the start of treatment. 4 weeks The assessment of the ulcer will performed by the nurse responsible for monitoring the ulcer. The ulcer will be considered fully healed when the surface is epithelialized.
Time (days) to ulcer healing from the start of treatment. up to 12 weeks The lesion will be considered fully healed when the surface is epithelialized. This will be confirmed by the nurse responsible for monitoring the lesion.
Changes in the wound bed at 8 weeks according to score of section 6 of the RESVECH2.0 ("Expected Results of the Assessment and Evaluation of Healing of Chronic Wounds" scale. 8 weeks The evaluation of changes will be conducted by a trained nurse to apply the RESVECH 2.0 scale. The scores in Section 6 of the RESVECH scale range from 0 to 14. The higher the score, the greater the severity of the injury.
The healthcare expenditure associated with each branch of the study 12 weeks A descriptive analysis of healthcare expenditure associated with each study branch will be conducted using billing data from the center, which is linked to the insured individual's resource utilization.
Change in ulcer area compared to baseline (percentage) at 4 weeks of treatment 4 weeks The assessment of the ulcer will include measuring its area through digital planimetry.
Change in ulcer area compared to baseline (percentage) at 12 weeks of treatment 12 weeks The assessment of the ulcer will include measuring its area through digital planimetry.
Trial Locations
- Locations (1)
Consorci Sanitari Alt'Pènedes i Garraf
🇪🇸Barcelona, Cataluña, Spain