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

Acetic Acid in Cutaneous Ulcers. A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ulcer, Skin
• Intervention / Treatment: Drug: Acetic Acid; Drug: Prontosan

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Marta De Vicente; Phone Number: +34 9389316161; Email: mdevicente@csapg.cat
• Study Contact Backup: Name: Noemí Casaponsa; Phone Number: 43197 +34 938960025; Email: recerca@csapg.cat

Study Locations

• Spain
  • Cataluña
    • Barcelona, Cataluña, Spain, 08810
      • Consorci Sanitari Alt'Pènedes i Garraf
      • Contact: Noemí Casaponsa; Phone Number: 43197 +34 938960025; Email: recerca@csapg.cat
      • Contact: Marta De Vicente; Phone Number: +34 938931616; Email: mdevicente@csapg.cat
      • Principal Investigator: Marta De Vicente

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.; Other Names: Acetic Acid 2%
Active Comparator: 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	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.; Other Names: 0,1 % Undecilenamidopropil betaine, 0,1 % Polyhexanide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Consorci Sanitari de l'Alt Penedès i Garraf
• Investigators: Principal Investigator: Marta De Vicente, CSAPG

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Skin Ulcer; Biofilms; Acetic Acid
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Ulcer; Skin Ulcer; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Gastrointestinal Agents; Protective Agents; Hypolipidemic Agents; Lipid Regulating Agents; Anti-Bacterial Agents; Adjuvants, Immunologic; Anticarcinogenic Agents; Lipotropic Agents; Betaine; Acetic Acid; Retinol acetate
• Other Study ID Numbers: CSAPG-33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research proposels and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
• IPD Sharing Time Frame: After publication of main results of the study.
• IPD Sharing Access Criteria: IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No