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Effect of Prontosan Wound Irrigation Solution on Venous Ulcers

NCT01048307 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-08-17

No results posted yet for this study

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

Interventions

DEVICE

Prontosan wound irrigation solution

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).

Sponsors & Collaborators

  • B. Braun Medical SA

    collaborator INDUSTRY

  • Calvary Hospital, Bronx, NY

    lead OTHER

Principal Investigators

  • Oscar M Alvarez, PhD · Calvary Hospital, Wound Care

  • Martin Wendelken, RN, DPM · Calvary Hospital, Wound Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01048307 on ClinicalTrials.gov