Efficacy of Prontosan Solution on Chronic Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcer; Wound Cleansing; Chronic Wound Care
• Intervention / Treatment: Device: Prontosan wound irrigation solution; Drug: Isotonic solution (saline or lactated ringer)

• Study Type: Interventional
• Enrollment (Actual): 289
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Firenze, Italy
    • Home nursing assistance
  • Pavia, Italy
    • Policlinico San Matteo
  • Trieste, Italy
    • Azienda Ospedaliero-Universitaria Ospedali Riuniti
  • Turin, Italy
    • Azienda Ospedaliero Universitaria San Giovanni Battista
  • Varese, Italy
    • Ospedale di Circolo-Fondazione Macchi
  • Milan
    • Busto Arsizio, Milan, Italy
      • Azienda Ospedaliera Ospedale di Circolo di Busto Arsizio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Associazione Infermieristica per lo studio delle Lesioni Cutanee
• Collaborators: B. Braun Medical SA

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: April 6, 2011
• First Submitted That Met QC Criteria: April 11, 2011
• First Posted (ESTIMATE): April 12, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 15, 2014
• Last Update Submitted That Met QC Criteria: January 14, 2014
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Wounds and Injuries; Pressure Ulcer; Pharmaceutical Solutions
• Other Study ID Numbers: AISLeC-001