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

Northwestern University8 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Wounds

Interventions

Pulse lavage treatmentPROCEDURE

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).

Dressing changesOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Northwestern Memorial Hospital

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 4 days

Secondary Outcomes

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.

Time frame: 4 days

Data from ClinicalTrials.gov

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