Back to resultsEfficacy of Prontosan Solution on Chronic Ulcers
Primary Purpose
Pressure Ulcer, Chronic Wound Care, Wound Cleansing
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Prontosan wound irrigation solution
Isotonic solution (saline or lactated ringer)
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcer
Eligibility 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
Sites / Locations
- Azienda Ospedaliera Ospedale di Circolo di Busto Arsizio
- Home nursing assistance
- Policlinico San Matteo
- Azienda Ospedaliero-Universitaria Ospedali Riuniti
- Azienda Ospedaliero Universitaria San Giovanni Battista
- Ospedale di Circolo-Fondazione Macchi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prontosan wound irrigation solution
Standard care
Arm Description
Outcomes
Primary Outcome Measures
Reduction of necrotic tissue (Pressure Sore Status Tool-PSST)
Reduction of inflammatory tissue(Pressure Sore Status Tool-PSST)
Secondary Outcome Measures
Frequency of wound dressing (clinical score)
Full Information
NCT ID
NCT01333670
First Posted
April 6, 2011
Last Updated
January 14, 2014
Sponsor
Associazione Infermieristica per lo studio delle Lesioni Cutanee
Collaborators
B. Braun Medical SA
1. Study Identification
Unique Protocol Identification Number
NCT01333670
Brief Title
Efficacy of Prontosan Solution on Chronic Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Associazione Infermieristica per lo studio delle Lesioni Cutanee
Collaborators
B. Braun Medical SA
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Chronic Wound Care, Wound Cleansing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
289 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prontosan wound irrigation solution
Arm Type
Experimental
Arm Title
Standard care
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Prontosan wound irrigation solution
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Isotonic solution (saline or lactated ringer)
Intervention Description
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
Primary Outcome Measure Information:
Title
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)
Title
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 Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Azienda Ospedaliera Ospedale di Circolo di Busto Arsizio
City
Busto Arsizio
State/Province
Milan
Country
Italy
Facility Name
Home nursing assistance
City
Firenze
Country
Italy
Facility Name
Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Ospedali Riuniti
City
Trieste
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria San Giovanni Battista
City
Turin
Country
Italy
Facility Name
Ospedale di Circolo-Fondazione Macchi
City
Varese
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Prontosan Solution on Chronic Ulcers
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