Acetic Acid 2% Solution for Skin Ulcers
ConditionUlcer, Skin
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorConsorci Sanitari de l'Alt Penedès i Garraf
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Ulcers with exposed bone tissue.
Neoplastic-origin ulcers.
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
Design model
Parallel
Treatments tested in this trial
Acetic Acid
DrugThe 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.
Prontosan
DrugThe 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.
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Acetic AcidExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
8 weeksSecondary outcomes
1
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.
Time frame
4 weeks2
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.
Time frame
12 weeks3
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.
Time frame
up to 12 weeks4
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.
Time frame
8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov