Efficacy of Prontosan Solution on Chronic Ulcers
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01333670 |
Recruitment Status
:
Completed
First Posted
: April 12, 2011
Last Update Posted
: January 15, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pressure Ulcer Chronic Wound Care Wound Cleansing | Device: Prontosan wound irrigation solution Drug: Isotonic solution (saline or lactated ringer) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 289 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Study Start Date : | April 2011 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Prontosan wound irrigation solution |
Device: Prontosan wound irrigation solution
|
Active Comparator: Standard care |
Drug: Isotonic solution (saline or lactated ringer)
|
- 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) ]
- 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) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01333670
Italy | |
Azienda Ospedaliera Ospedale di Circolo di Busto Arsizio | |
Busto Arsizio, Milan, Italy | |
Home nursing assistance | |
Firenze, Italy | |
Policlinico San Matteo | |
Pavia, Italy | |
Azienda Ospedaliero-Universitaria Ospedali Riuniti | |
Trieste, Italy | |
Azienda Ospedaliero Universitaria San Giovanni Battista | |
Turin, Italy | |
Ospedale di Circolo-Fondazione Macchi | |
Varese, Italy |
Responsible Party: | Associazione Infermieristica per lo studio delle Lesioni Cutanee |
ClinicalTrials.gov Identifier: | NCT01333670 History of Changes |
Other Study ID Numbers: |
AISLeC-001 |
First Posted: | April 12, 2011 Key Record Dates |
Last Update Posted: | January 15, 2014 |
Last Verified: | April 2011 |
Additional relevant MeSH terms:
Wounds and Injuries Pressure Ulcer Skin Ulcer Skin Diseases Pharmaceutical Solutions |