2% acetic acid solution for chronic skin ulcers with biofilm
Acetic Acid in Cutaneous Ulcers. A Randomized Controlled Trial
This trial will try a 2% topical acetic acid solution to see if it heals chronic skin ulcers with biofilm better than the current Prontosan® treatment in adults cared for at the center.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Consorci Sanitari de l'Alt Penedès i Garraf Academic / other |
| Locations | 1 site (Barcelona, Catalonia) |
| Trial ID | NCT06297967 on ClinicalTrials.gov |
What this trial studies
This Phase 3 randomized interventional trial will assign adult patients with chronic cutaneous ulcers containing biofilm to receive either a 2% acetic acid topical solution or the center's standard treatment, Prontosan®. Eligible ulcers must be under 120 cm², not located on the face, and patients must be followed at the study center for at least eight weeks. Key exclusions include ulcers with exposed bone, ulcers of neoplastic origin, and ulcers present for more than 18 months. The primary aim is to determine whether the acetic acid arm is superior to Prontosan® for managing biofilm-associated chronic ulcers at this center.
Who should consider this trial
Good fit: Adults receiving care at Consorci Sanitari Alt Penedès i Garraf who have a non-facial cutaneous ulcer with biofilm under 120 cm², can attend follow-up visits, and can provide informed consent are ideal candidates.
Not a fit: Patients with ulcers exposing bone, ulcers of neoplastic origin, ulcers present for more than 18 months, or those unable to receive follow-up at the study center are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could provide a low-cost topical option that more effectively clears biofilm and promotes healing of chronic skin ulcers.
How similar studies have performed: Smaller clinical reports and observational data suggest topical acetic acid can reduce wound bacteria and biofilm, but large randomized Phase 3 comparisons against products like Prontosan® are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Barcelona, Catalonia
- Consorci Sanitari Alt'Pènedes i Garraf — Barcelona, Catalonia, Spain (Recruiting)
Study contacts
- Principal investigator: Marta De Vicente — Csapg
- Study coordinator: Marta De Vicente
- Email: mdevicente@csapg.cat
- Phone: +34 9389316161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.