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Efficacy of Prontosan Solution on Chronic Ulcers

This study has been completed.
Sponsor:
Collaborator:
B. Braun Medical SA
Information provided by (Responsible Party):
Associazione Infermieristica per lo studio delle Lesioni Cutanee
ClinicalTrials.gov Identifier:
NCT01333670
First received: April 6, 2011
Last updated: January 14, 2014
Last verified: April 2011
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Associazione Infermieristica per lo studio delle Lesioni Cutanee:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 289
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Associazione Infermieristica per lo studio delle Lesioni Cutanee
ClinicalTrials.gov Identifier: NCT01333670     History of Changes
Other Study ID Numbers: AISLeC-001
Study First Received: April 6, 2011
Last Updated: January 14, 2014
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014