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Completed

NCT Number: NCT01333670

Efficacy of Prontosan Solution on Chronic Ulcers

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.

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Key information

Conditions

Pressure Ulcer Chronic Wound Care Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Wound Cleansing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Azienda Ospedaliera Ospedale di Circolo di Busto Arsizio, Busto Arsizio, Milan, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prontosan wound irrigation solution

Device
  • 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

Isotonic solution (saline or lactated ringer)

Drug
  • 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

Primary outcomes

  1. Reduction of necrotic tissue (Pressure Sore Status Tool-PSST)

    Time frame: From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly)

  2. Reduction of inflammatory tissue(Pressure Sore Status Tool-PSST)

    Time frame: From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly)

Secondary outcomes

  1. Frequency of wound dressing (clinical score)

    Time frame: From basaline visit to the final visit, that is between a minimum of 1 visit (10 days later) or a maximum of 4 visits (1 month later, weekly)

Sponsors and collaborators

Lead sponsor

Associazione Infermieristica per lo studio delle Lesioni Cutanee

Other

Collaborators

  • B. Braun Medical SA

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 12, 2011
Registry last updated
Jan 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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