Evaluation of the Effectiveness of Daily Pulse Lavage Therapy in Chronic Wounds (PLI2)
This study evaluates the effectiveness of pulse lavage therapy in decreasing bacterial counts in chronic wounds.
|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|
- 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.
- 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.
|Study Start Date:||December 2011|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
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).
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500746
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Robert D Galiano, MD||Northwestern University|