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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

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 Design

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
Primary Completion Date : November 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Prontosan wound irrigation solution Device: 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
Active Comparator: Standard care Drug: 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


Outcome Measures

Primary Outcome Measures :
  1. 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) ]
  2. 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) ]

Secondary Outcome Measures :
  1. 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) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Associazione Infermieristica per lo studio delle Lesioni Cutanee
B. Braun Medical SA
More Information

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