Efficacy of Prontosan Solution on Chronic Ulcers

NCT01333670 | Completed Phase 3 DMC

• 1 other identifier: AISLeC-001
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 6

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.

Conditions

Pressure Ulcer; Chronic Wound Care; Wound Cleansing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Prontosan wound irrigation solution

EXPERIMENTAL

Device: Prontosan wound irrigation solution

Standard care

ACTIVE COMPARATOR

Drug: Isotonic solution (saline or lactated ringer)

Interventions

Prontosan wound irrigation solution DEVICE

* 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

Prontosan wound irrigation solution

Isotonic solution (saline or lactated ringer) DRUG

* 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

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Associazione Infermieristica per lo studio delle Lesioni Cutanee: lead
• B. Braun Medical SA: collaborator

Study Sites (6)

Azienda Ospedaliera Ospedale di Circolo di Busto Arsizio

Busto Arsizio, Milan, Italy

Location

Home nursing assistance

Florence, Italy

Location

Policlinico San Matteo

Pavia, Italy

Location

Azienda Ospedaliero-Universitaria Ospedali Riuniti

Trieste, Italy

Location

Azienda Ospedaliero Universitaria San Giovanni Battista

Turin, Italy

Location

Ospedale di Circolo-Fondazione Macchi

Varese, Italy

Location

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Isotonic Solutions; Sodium Chloride; Ringer's Lactate

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 12, 2011
• Study Start: April 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 15, 2014

Record last verified: 2011-04

Locations

IT (6)