Efficacy of Prontosan Solution on Chronic Ulcers

Phase 3

Completed

• Conditions: Pressure Ulcer; Chronic Wound Care; Wound Cleansing
• Interventions: Device: Prontosan wound irrigation solution; Drug: Isotonic solution (saline or lactated ringer)

• Registration Number: NCT01333670
• Lead Sponsor: Associazione Infermieristica per lo studio delle Lesioni Cutanee

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-04
• Study Start: 2011-04
• Study First Submitted: 2011-04-06
• Study First Submitted QC: 2011-04-11
• Study First Posted: 2011-04-12
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prontosan wound irrigation solution	Prontosan wound irrigation solution	-
Standard care	Isotonic solution (saline or lactated ringer)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (6)

Policlinico San Matteo; 🇮🇹 Pavia, Italy

Azienda Ospedaliera Ospedale di Circolo di Busto Arsizio; 🇮🇹 Busto Arsizio, Milan, Italy

Azienda Ospedaliero Universitaria San Giovanni Battista; 🇮🇹 Turin, Italy

Ospedale di Circolo-Fondazione Macchi; 🇮🇹 Varese, Italy

Home nursing assistance; 🇮🇹 Firenze, Italy

Azienda Ospedaliero-Universitaria Ospedali Riuniti; 🇮🇹 Trieste, Italy