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

Northwestern University

Status: Completed

Conditions: Chronic Wounds

Treatments: Other: Dressing changes; Procedure: Pulse lavage treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01500746

STU00057288

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Lavage arm

Experimental group

Description:

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.

Treatment:

Procedure: Pulse lavage treatment

Moist dressings

Active Comparator group

Description:

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.

Treatment:

Other: Dressing changes