Acetic Acid 2% Solution for Skin Ulcers (ECA-AA)

Consorci Sanitari de l'Alt Penedès i Garraf

Status and phase: Enrolling; Phase 3

Conditions: Ulcer, Skin

Treatments: Drug: Prontosan; Drug: Acetic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06297967

CSAPG-33

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Acetic Acid

Experimental group

Description:

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

Treatment:

Drug: Acetic Acid

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Prontosan