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Completed

NCT Number: NCT01500746

Evaluation of the Effectiveness of Daily Pulse Lavage Therapy in Chronic Wounds

This study evaluates the effectiveness of pulse lavage therapy in decreasing bacterial counts in chronic wounds.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

Pulse lavage irrigation is an effective method of cleaning both acute and chronic wounds. The major drawback to pulse irrigation is that it is extremely messy and can easily contaminate the patient's surroundings, putting other patients and the person operating the device at risk. In order to obtain the benefits of pulse lavage, we have created a device that will contain the water spray from the lavage and protect both the patient and their surroundings. Due to the fact that frequent (multiple times daily) pulse lavage therapy has not been possible previously, it is unknown how effectively serial pulse lavage irrigation reduces bacterial counts. This study evaluates the effectiveness of serial pulse lavage therapy in decreasing bacterial counts in chronic wounds.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must have a chronic wound (as defined by the wound being present for >30 days) located on any part of their body
  • The wound must be smaller than 10cm in greatest diameter.
  • Patients must have an expected remaining hospital duration of 4 days
  • Patients must be willing and able to comply with all study procedures

Exclusion criteria

  • Patients must not have undergone any surgical excisions or debridements of the wound in the past 30 days
  • The wound may not undergo any surgical procedures or other treatments other than the study treatments during the course of the study.
  • The wound may not require any immediate surgical intervention or debridement
  • Patients may not start any new antibiotic therapy during the course of the study
  • Must not have an allergy to skin adhesives.
  • Patients must not be taking any immunosuppressive medications.
  • Subjects who, in the opinion of the investigator, may not complete the study for any reason.

Treatment and study plan

Pulse lavage treatment

Procedure

A pulse lavage machine will be used to irrigate the wound with a total of 4 liters of water, twice daily, for a total of 4 days (8 treatments).

Other names: Pulsed lavage (Stryker Pulsavac Plus), Wound containment apparatus

Dressing changes

Other

Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments).

Primary outcomes

  1. Change in Bacterial Counts

    Time frame: Baseline and at 4 days

    A punch biopsy of the wound will be taken once the subject is enrolled in the study. A repeat biopsy will be taken after the 8th lavage treatment or the 8th dressing change. These will be sent for bacterial count analysis and the difference in bacterial counts will be evaluated. The lavage fluid from baseline measurements will be filtered and sent for bacterial counts and will be compared to the filtered fluid from the last lavage treatment. In addition, surface swabs will be taken at the beginning and end of the study and will be sent for bacterial counts as well. Bacterial counts from these lavage, biopsy specimen, and swabs will be averaged and analyzed.

  2. Change in Gene Expression Analysis

    Time frame: 4 days

    A punch biopsy will be taken at the beginning of the study. this will be sent for gene expression analysis. A repeat biopsy at the end of the study will also be sent at the end of the study, and a change in gene expression in analysis will be evaluated.

Secondary outcomes

  1. Pain With Lavage Treatments

    Time frame: 4 days

    After each lavage treatment, the subjects will complete a visual analogue scale that will determine the level of discomfort that they experienced during the study.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Bedside Pulse Lavage Irrigation Project

Acronym: PLI2

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 28, 2011
Registry last updated
Apr 14, 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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