Effect of Prontosan Wound Irrigation Solution on Venous Ulcers

NCT01048307 | Completed

• 1 other identifier: OPM-I-H-0902
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Wound Care; Venous Ulcer Care; Wound Cleansing; Chronic Wound Care

Keywords

prontosan; wound cleansing; wound irrigation; phmb; polihexanide; betaine

Outcome Measures

Primary Outcomes (1)

• Reduction of bacterial burden (quantitative bacteriology) Reduction in slough and necrotic tissue (clinical score) Amount and quality of granulation tissue (clinical score) Exudate type and amount (clinical score)

  weekly

Secondary Outcomes (1)

• Adverse device effect (s) Adverse events

  volunteered at any time or during weekly evaluation visits

Study Arms (2)

Prontosan wound irrigation solution

EXPERIMENTAL

Prontosan® Wound Irrigation Solution (experimental group): * cleansing the wound bed at dressing change with Prontosan® Wound Irrigation Solution; a sterile gauze dressing impregnated with the Prontosan® solution will be placed on the wound in the form of a moist compress and removed after approx.15 minutes; * placing the primary dressing (Profore® WCL): the dressing will be impregnated with Prontosan® Wound Irrigation Solution; * fixing the dressing to the wound using multilayered elastic compression bandaging (Profore®bandaging system).

Device: Prontosan wound irrigation solution

Saline irrigation (standard care control)

PLACEBO COMPARATOR

Saline (control group): * cleansing the wound bed at dressing change with saline; a sterile gauze dressing impregnated with the saline will be placed on the wound in the form of a moist compress and removed after approx.15 minutes; * placing the primary dressing (Profore® WCL): the dressing will be impregnated with saline; * fixing the dressing to the wound using multilayered elastic compression bandaging (Profore® bandaging system).

Device: Prontosan wound irrigation solution

Interventions

Prontosan wound irrigation solution DEVICE

Prontosan® Wound Irrigation Solution (experimental group): • Active ingredients (Polihexanide 0.1%, Betaine 0.1%) cleansing the wound bed at dressing change with Prontosan® Wound Saline (control group): * cleansing the wound bed at dressing change with saline; a sterile gauze dressing impregnated with the saline will be placed on the wound in the form of a moist compress and removed after approx.15 minutes; * placing the primary dressing (Profore® WCL): the dressing will be impregnated with saline; * fixing the dressing to the wound using multilayered elastic compression bandaging (Profore® bandaging system).

Also known as: Wound irrigation solution containing PHMB, Polihexanide, Betaine, Wound cleanser

Prontosan wound irrigation solution; Saline irrigation (standard care control)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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)

Sponsors & Collaborators

• Calvary Hospital, Bronx, NY: lead
• B. Braun Medical SA: collaborator

Study Sites (1)

Calvary hospital center for curative and palliative wound care

The Bronx, New York, 10461, United States

Location

Study Officials

• Oscar M Alvarez, PhD

  Calvary Hospital, Wound Care

  PRINCIPAL INVESTIGATOR

• Martin Wendelken, RN, DPM

  Calvary Hospital, Wound Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: June 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 17, 2010

Record last verified: 2010-08

Locations

US (1)