Effect of Prontosan Wound Irrigation Solution on Venous Ulcers

Completed · Not applicable

Conditions studied: Wound Care, Venous Ulcer Care, Wound Cleansing, Chronic Wound Care

In brief

Objective: To evaluate the efficacy and safety of Prontosan® Wound Irrigation Solution in the treatment of hard-to-heal venous leg ulcers compared to wound irrigation with saline solution Methodology: Randomised, controlled multi-centre, prospective clinical trial Planned number of subjects: 20 patients in experimental group (Prontosan® Wound Irrigation Solution) 8 patients in control group (wound irrigation with saline) Products under investigation: Prontosan® Wound Irrigation Solution Study Duration: 3-4 weeks

Key facts

Study ID

NCT01048307

Run by

Calvary Hospital, Bronx, NY

People needed

20

Starts

2009-06-01

Expected to finish

2010-07-01

Last updated by the study team

2010-08-17

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• males and females aged at least 18 with wounds of venous aetiology (documented by targeted exams) located in the lower limbs
• Ankle Brachial Index (ABI) ≥ 0.7
• patients who have not had an antimicrobial (systemic antibiotic or topical antiseptic) over the 30 days before joining the study

You may not qualify if…

• Exclusion criteria
• age below 18 years
• presence of clinical infection, or current use of antiseptics or antibiotics
• chronic wounds of long duration (>30cm2 and >1 year duration)
• involvement in other wound related trials within the past 30 days
• sensitivity to any of the components of Prontosan® or dressing material
• intolerance to compression therapy
• active osteomyelitis in the ulceration area
• active rheumatoid arthritis (RA) requiring any immunosuppressive therapy
• collagen vascular disease active treated with steroids
• chronic diseases that could impact the course of the study (malicious cancer, TB, AIDS, mental illnesses)
• plasma protein below 4 g/dl
• anaemia: haemoglobin below 10 g/dl
• both, controlled and uncontrolled diabetics (type 1 or 2)
• patients on any rheological agents (not including aspirin)

Where it is running

• Calvary hospital center for curative and palliative wound care — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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