Acetic Acid 2% Solution for Skin Ulcers

NCT ID: NCT06297967

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-27
• Study Completion Date: 2027-03-31

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.

Conditions

Ulcer, Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Acetic Acid

Intervention Type: DRUG

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.

Control group

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

Group Type: ACTIVE_COMPARATOR

Prontosan

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Acetic Acid 2%; 0,1 % Undecilenamidopropil betaine, 0,1 % Polyhexanide

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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorci Sanitari de l'Alt Penedès i Garraf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marta De Vicente

Role: PRINCIPAL_INVESTIGATOR

CSAPG

Locations

Consorci Sanitari Alt'Pènedes i Garraf

Barcelona, Catalonia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Marta De Vicente

Role: CONTACT

mdevicente@csapg.cat

+34 9389316161

Noemí Casaponsa

Role: CONTACT

recerca@csapg.cat

+34 938960025 ext. 43197

Facility Contacts

Marta De Vicente

Role: primary

mdevicente@csapg.cat

+34 938931616

Noemí Casaponsa

Role: backup

recerca@csapg.cat

+34 938960025 ext. 43197

Other Identifiers

CSAPG-33

Identifier Type: -

Identifier Source: org_study_id