Acetic Acid 2% Solution for Skin Ulcers

Last updated: January 2, 2025
Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
Overall Status: Active - Not Recruiting

Phase

3

Condition

Ulcers

Pressure Ulcer

Treatment

Acetic Acid

Prontosan

Clinical Study ID

NCT06297967
CSAPG-33
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients over 18 years of age.

  • Continued care (hospital or outpatient) in one of the Consorci Sanitari Alt Penedesi Garraf (CSAPG) units.

  • Presence of a cutaneous ulcer with biofilm, with an area of less than 120 cm2, andin any location (except the facial region).

  • Plan to undergo treatment and follow-up of the lesion (at least 8 weeks) at thestudy center.

  • Ability to cooperate in necessary evaluations.

  • Informed consent for inclusion in the study, either from the participant themselvesor from their legal representative.

Exclusion

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 interventionduring the period of the current trial and/or establishing a visit frequencyincompatible with the current trial.

Study Design

Total Participants: 104
Treatment Group(s): 2
Primary Treatment: Acetic Acid
Phase: 3
Study Start date:
March 01, 2025
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Consorci Sanitari Alt'Pènedes i Garraf

    Barcelona, Cataluña 08810
    Spain

    Site Not Available

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