Efficacy of Prontosan Solution on Chronic Ulcers

Associazione Infermieristica per lo studio delle Lesioni Cutanee

Status and phase: Completed; Phase 3

Conditions: Chronic Wound Care; Pressure Ulcer; Wound Cleansing

Treatments: Drug: Isotonic solution (saline or lactated ringer); Device: Prontosan wound irrigation solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01333670

AISLeC-001

Details and patient eligibility

About

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.

Enrollment: 289 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

289 participants in 2 patient groups

Prontosan wound irrigation solution

Experimental group

Treatment:

Device: Prontosan wound irrigation solution

Standard care

Active Comparator group

Treatment:

Drug: Isotonic solution (saline or lactated ringer)