NCT01333670

Efficacy of Prontosan Solution on Chronic Ulcers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 289 (actual)
• Sponsor: Associazione Infermieristica per lo studio delle Lesioni Cutanee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-11-01
• Completion: 2012-12-01
• First posted: 2011-04-12
• Last updated: 2014-01-15

Locations

6 sites across 1 country: Italy