Efficacy of Prontosan Solution on Chronic Ulcers

Associazione Infermieristica per lo studio delle Lesioni Cutanee289 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

289

Conditions

Pressure Ulcer Chronic Wound Care Wound Cleansing

Interventions

Prontosan wound irrigation solutionDEVICE

* 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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Azienda Ospedaliera Ospedale di Circolo di Busto Arsizio

Busto Arsizio, Milan, Italy

Home nursing assistance

Florence, Italy

Policlinico San Matteo

Pavia, Italy

Azienda Ospedaliero-Universitaria Ospedali Riuniti

Trieste, Italy

Outcomes

Primary Outcomes

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)

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 Outcomes

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)

Data from ClinicalTrials.gov

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