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

Not Applicable

Completed

• Conditions: Chronic Wounds
• Interventions: Procedure: Pulse lavage treatment; Other: Dressing changes

• Registration Number: NCT01500746
• Lead Sponsor: Northwestern University

Brief Summary

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

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-23
• Study First Submitted QC: 2011-12-23
• Study First Posted: 2011-12-28
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Results First Submitted: 2014-01-20
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-10
• Last Update Submitted: 2014-03-10
• Results First Posted: 2014-04-14
• Last Update Posted: 2014-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lavage arm	Pulse lavage treatment	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.
Moist dressings	Dressing changes	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.

Primary Outcome Measures

Name	Time	Method
Change in Gene Expression Analysis	4 days	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.
Change in Bacterial Counts	Baseline and at 4 days	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.

Secondary Outcome Measures

Name	Time	Method
Pain With Lavage Treatments	4 days	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.

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States