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Acetic Acid 2% Solution for Skin Ulcers

NCT06297967 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-06-26

No results posted yet for this study

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

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 the nurse's discretion.

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.

Sponsors & Collaborators

  • Consorci Sanitari de l'Alt Penedès i Garraf

    lead OTHER

Principal Investigators

  • Marta De Vicente · CSAPG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-27
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06297967 on ClinicalTrials.gov