Efficacy of Prontosan Solution on Chronic Ulcers

Pressure Ulcer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333670
• Other study ID #: AISLeC-001
• Status: Completed
• Phase: Phase 3
• First received: April 6, 2011
• Last updated: January 14, 2014
• Start date: April 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2011
• Source: Associazione Infermieristica per lo studio delle Lesioni Cutanee
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Wound Care
• Pressure Ulcer
• Wound Cleansing

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Associazione Infermieristica per lo studio delle Lesioni Cutanee	B. Braun Medical SA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of necrotic tissue (Pressure Sore Status Tool-PSST)		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)	No
Primary	Reduction of inflammatory tissue(Pressure Sore Status Tool-PSST)		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)	No
Secondary	Frequency of wound dressing (clinical score)		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)	No