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

April 6, 2011
January 14, 2014
April 2011
November 2012   (final data collection date for 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) ] [ 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 ]
Same as current
Complete list of historical versions of study NCT01333670 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Efficacy of Prontosan Solution on Chronic Ulcers
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Pressure Ulcer
  • Chronic Wound Care
  • Wound Cleansing
  • 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
  • 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
  • Experimental: Prontosan wound irrigation solution
    Intervention: Device: Prontosan wound irrigation solution
  • Active Comparator: Standard care
    Intervention: Drug: Isotonic solution (saline or lactated ringer)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
289
December 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01333670
AISLeC-001
Yes
Associazione Infermieristica per lo studio delle Lesioni Cutanee
Associazione Infermieristica per lo studio delle Lesioni Cutanee
B. Braun Medical SA
Not Provided
Associazione Infermieristica per lo studio delle Lesioni Cutanee
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP