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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Galiano, Northwestern University
ClinicalTrials.gov Identifier:
NCT01500746
First received: December 23, 2011
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bedside Pulse Lavage Irrigation Project

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Change in Bacterial Counts [ Time Frame: Baseline and at 4 days ] [ Designated as safety issue: No ]
    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.

  • Change in Gene Expression Analysis [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    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:
  • Pain With Lavage Treatments [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 8
Study Start Date: December 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500746

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

Publications:
Responsible Party: Robert Galiano, Assistant Professor of Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT01500746     History of Changes
Other Study ID Numbers: STU00057288
Study First Received: December 23, 2011
Results First Received: January 20, 2014
Last Updated: March 10, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 21, 2014