Pressure UlcerPhase 3NCT01333670
Efficacy of Prontosan Solution on Chronic Ulcers
A Phase 3 study testing Prontosan wound irrigation solution and Isotonic solution (saline or lactated ringer) in people with Pressure Ulcer and Chronic Wound Care, run by Associazione Infermieristica per lo studio delle Lesioni Cutanee at 6 sites in Italy.
Trial summary
The purpose of this study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution compared with standard isotonic solution on infammation reduction and wound bed cleansing of chronic pressure or vascular leg ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer, Chronic Wound Care, Wound Cleansing
- What is being tested?
- Prontosan wound irrigation solution and Isotonic solution (saline or lactated ringer)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 6 sitesItaly
- Study dates
- Apr 2011to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and females aged at least 18 with Pressure ulcer stage 2-3 NPUAP (National Pressure Ulcer Advisory Panel 1989)or subcutaneous vascular ulcer with inflammation and/or biofilm and/or slough
- Braden index at baseline>=10
- Ulcer area<80 cm2
- Ability to give an informed consent
Who cannot join
- Braden index at baseline<10
- Current therapy with corticosteroids or immunosuppressor or radiotherapy
- Sensitivity to any of the components of Prontosan® Solution
- Diabetic foot ulcer
- Current use of local antiseptics on the wound bed
- Previous recruitment of another ulcer in the trial
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Azienda Ospedaliera Ospedale di Circolo di Busto Arsizio
Busto Arsizio, Milan
Home nursing assistance
Florence
Policlinico San Matteo
Pavia
Azienda Ospedaliero-Universitaria Ospedali Riuniti
Trieste
Azienda Ospedaliero Universitaria San Giovanni Battista
Turin
Ospedale di Circolo-Fondazione Macchi
Varese
About this study
The purpose of this study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution compared with standard isotonic solution on infammation reduction and wound bed cleansing of chronic pressure or vascular leg ulcers.
- Conditions
- Pressure Ulcer, Chronic Wound Care, Wound Cleansing
- Being tested
- Prontosan wound irrigation solution, Isotonic solution (saline or lactated ringer)
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prontosan wound irrigation solutionDevice
- cleansing wound bed at change with Prontosan Wound Irrigation solution (syringe 20-30 ml, needle 19-20 G)
- positioning of sterile gauze dressing impregnated with Prontosan Wound Irrigation solution on the wound for 10 minutes
- dressing with Prontosan Wound Irrigation solution
Isotonic solution (saline or lactated ringer)Drug
- cleansing wound bed at change with isotonic solution (syringe 20-30 ml, needle 19-20 G)
- positioning of sterile gauze dressing impregnated with isotonic solution on the wound for 10 minutes
- dressing with isotonic solution
| Study group | Role | What they receive |
|---|---|---|
| Prontosan wound irrigation solution | Experimental | Not described Receives: Device: Prontosan wound irrigation solution |
| Standard care | Active comparator | Not described Receives: Drug: Isotonic solution (saline or lactated ringer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of necrotic tissue (Pressure Sore Status Tool-PSST)
Measured: From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly)
Reduction of inflammatory tissue(Pressure Sore Status Tool-PSST)
Measured: From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly)
Secondary outcomes (1)
Frequency of wound dressing (clinical score)
Measured: From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associazione Infermieristica per lo studio delle Lesioni Cutanee
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Medical SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333670
- Sponsor's protocol ID
- AISLeC-001
- Status last verified
- Apr 2011
- First submitted
- 6 Apr 2011
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Prontosan Solution on Chronic Ulcers
- ClinicalTrials.gov ID
- NCT01333670
- Acronym / sponsor ID
- AISLeC-001
- Conditions
- Pressure Ulcer, Chronic Wound Care, Wound Cleansing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Associazione Infermieristica per lo studio delle Lesioni CutaneeUniversity, hospital or other
- Collaborators
- B. Braun Medical SA
- Study start
- Apr 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution compared with standard isotonic solution on infammation reduction and wound bed cleansing of chronic pressure or vascular leg ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prontosan wound irrigation solution | Experimental | Device: Prontosan wound irrigation solution |
| Standard care | Active comparator | Drug: Isotonic solution (saline or lactated ringer) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and females aged at least 18 with Pressure ulcer stage 2-3 NPUAP (National Pressure Ulcer Advisory Panel 1989)or subcutaneous vascular ulcer with inflammation and/or biofilm and/or slough
- Braden index at baseline>=10
- Ulcer area<80 cm2
- Ability to give an informed consent
Key exclusion criteria (6 listed)
- Braden index at baseline<10
- Current therapy with corticosteroids or immunosuppressor or radiotherapy
- Sensitivity to any of the components of Prontosan® Solution
- Diabetic foot ulcer
- Current use of local antiseptics on the wound bed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prontosan wound irrigation solution* cleansing wound bed at change with Prontosan Wound Irrigation solution (syringe 20-30 ml, needle 19-20 G) * positioning of sterile gauze dressing impregnated with Prontosan Wound Irrigation solution on the wound for 10 minutes * dressing with Prontosan Wound Irrigation solution | Device | Prontosan wound irrigation solution |
| Isotonic solution (saline or lactated ringer)* cleansing wound bed at change with isotonic solution (syringe 20-30 ml, needle 19-20 G) * positioning of sterile gauze dressing impregnated with isotonic solution on the wound for 10 minutes * dressing with isotonic solution | Drug | Standard care |
Primary outcome
Reduction of necrotic tissue (Pressure Sore Status Tool-PSST)
Time frame: From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly)
Reduction of inflammatory tissue(Pressure Sore Status Tool-PSST)
Time frame: From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly)
1 secondary outcome
Frequency of wound dressing (clinical score)
Time frame: From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prontosan wound irrigation solution and Isotonic solution (saline or lactated ringer) in people with Pressure Ulcer and Chronic Wound Care, run by Associazione Infermieristica per lo studio delle Lesioni Cutanee at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of necrotic tissue (Pressure Sore Status Tool-PSST) (time frame: From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2014; AzTrials last refreshed its copy on 3 Nov 2026.