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Evaluation of the Effectiveness of Daily Pulse Lavage Therapy in Chronic Wounds (PLI2)

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ClinicalTrials.gov Identifier: NCT01500746
Recruitment Status : Completed
First Posted : December 28, 2011
Results First Posted : April 14, 2014
Last Update Posted : April 14, 2014
Information provided by (Responsible Party):
Robert Galiano, Northwestern University

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

Condition or disease Intervention/treatment
Chronic Wounds Procedure: Pulse lavage treatment Other: Dressing changes

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bedside Pulse Lavage Irrigation Project
Study Start Date : December 2011
Primary Completion Date : October 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lavage arm
This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.
Procedure: Pulse lavage treatment
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
Active Comparator: Moist dressings
This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.
Other: Dressing changes
Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments).

Primary Outcome Measures :
  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 Outcome Measures :
  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.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500746

United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: Robert D Galiano, MD Northwestern University

Responsible Party: Robert Galiano, Assistant Professor of Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT01500746     History of Changes
Other Study ID Numbers: STU00057288
First Posted: December 28, 2011    Key Record Dates
Results First Posted: April 14, 2014
Last Update Posted: April 14, 2014
Last Verified: March 2014

Keywords provided by Robert Galiano, Northwestern University:
chronic wound treatment
pulse lavage
serial pulse lavage
bacterial colonization of wounds

Additional relevant MeSH terms:
Wounds and Injuries