Acetic Acid 2% Solution for Skin Ulcers

Ulcer, Skin Clinical Trial

— ECA-AA  

Official title:

Acetic Acid in Cutaneous Ulcers. A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06297967
• Other study ID #: CSAPG-33
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 2024
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: Consorci Sanitari de l'Alt Penedès i Garraf
• Contact: Marta De Vicente
• Phone: +34 9389316161
• Email: mdevicente[@]csapg.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: June 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Ulcers with exposed bone tissue.

2. Neoplastic-origin ulcers.

3. 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.

Related Conditions & MeSH terms

• Skin Ulcer
• Ulcer
• Ulcer, Skin

Intervention

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 the nurse's discretion.
• 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.

Locations

Country	Name	City	State
Spain	Consorci Sanitari Alt'Pènedes i Garraf	Barcelona	Cataluña

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de l'Alt Penedès i Garraf

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ulcer area compared to baseline (percentage) at 8 weeks of treatment	The assessment of the ulcer will include measuring its area through digital planimetry.	8 weeks
Secondary	Percentage of participants with ulcer healing at 4 weeks from the start of treatment.	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.	4 weeks
Secondary	Percentage of participants with ulcer healing at 12 weeks from the start of treatment.	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.	12 weeks
Secondary	Time (days) to ulcer healing from the start of treatment.	The lesion will be considered fully healed when the surface is epithelialized. This will be confirmed by the nurse responsible for monitoring the lesion.	up to 12 weeks
Secondary	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.	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.	8 weeks
Secondary	Number of adverse reactions associated with the treatment, collected from the medical record.	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.	12 weeks
Secondary	The healthcare expenditure associated with each branch of the study	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.	12 weeks