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

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

Detailed Description
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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.

Official Title
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Bedside Pulse Lavage Irrigation Project

Conditions
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Chronic Wounds

Intervention / Treatment
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* Procedure: Pulse lavage treatment
* Other: Dressing changes


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lavage arm<br>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<br>* 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).<br>* Other names: Wound containment apparatus;|
| Active Comparator: Moist dressings<br>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<br>* Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bacterial Counts | 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. | Baseline and at 4 days | 
| Change in Gene Expression Analysis | 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. | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain With Lavage Treatments | 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. | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic wound treatment, pulse lavage, serial pulse lavage, wounds, bacterial colonization of wounds