Recruiting NCT06297967
Acetic Acid 2% Solution for Skin Ulcers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acetic Acid, Prontosan.
- Who it may be relevant to
- Registry conditions: Ulcer, Skin. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Acetic Acid in Cutaneous Ulcers. A Randomized Controlled Trial
Overview
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.
Interventions
- Drug Acetic Acid
The intervention treatment will consist of cleaning with water and soap, application of a compress soaked in 2% dilution of glacial acetic acid (CAS 64-19-7) for 15 minutes, irrigation with distilled water, application of peri-ulcer barrier cream or spray, and the application of ActicoatⓇ on the ulcer bed. Depending on the amount of exudate, more or less alginate will be added as a secondary dressing. A tertiary dressing of polyurethane foam or bandage will be applied according to the area and t - Drug Prontosan
The treatment includes ulcer cleansing with water and soap, application of ProntosanⓇ compress for 15 minutes, subsequent irrigation with distilled water, application of peri-ulcer barrier cream or spray, and the application of ActicoatⓇ on the wound bed. More or less alginate will be applied depending on the amount of exudate. A tertiary dressing of polyurethane foam or bandage will be applied according to the area and the nurse's discretion.
Primary outcome measures
- Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment [Time frame: 8 weeks]
Secondary outcome measures (8)
- Percentage of participants with ulcer healing at 4 weeks from the start of treatment. [Time frame: 4 weeks]
- Percentage of participants with ulcer healing at 12 weeks from the start of treatment. [Time frame: 12 weeks]
- Time (days) to ulcer healing from the start of treatment. [Time frame: up to 12 weeks]
- 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. [Time frame: 8 weeks]
- Number of adverse reactions associated with the treatment, collected from the medical record. [Time frame: 12 weeks]
- The healthcare expenditure associated with each branch of the study [Time frame: 12 weeks]
- Change in ulcer area compared to baseline (percentage) at 4 weeks of treatment [Time frame: 4 weeks]
- Change in ulcer area compared to baseline (percentage) at 12 weeks of treatment [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Participants diagnosed with any of the following conditions:
- Ulcers with exposed bone tissue.
- Neoplastic-origin ulcers.
- Ulcers lasting more than 18 months.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Consorci Sanitari Alt'Pènedes i Garraf — Barcelona
Identifiers
NCT: NCT06297967 · CSAPG-33