Evaluation of the Effectiveness of Daily Pulse Lavage Therapy in Chronic Wounds - Full Text View

Purpose

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

Condition	Intervention
Chronic Wounds	Procedure: Pulse lavage treatment Other: Dressing changes

Study Type:	Interventional
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

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Change in bacterial counts [ Time Frame: 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 the first treatment 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.
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.

Secondary Outcome Measures:

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.
change in bacterial distribution [ Time Frame: 4 days ] [ Designated as safety issue: No ]
a small sample of the biopsy specimen from before and after treatment will be analyzed histologically to evaluate if the bacterial distribution in the wound changed over the course of treatment

Estimated Enrollment:	30
Study Start Date:	December 2011
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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). Other Names: Pulsed lavage (Stryker Pulsavac Plus) Wound containment apparatus
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).

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500746

Locations

United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Baxter Healthcare Corporation

Investigators

Principal Investigator:

Robert D Galiano, MD

Northwestern University

More Information

Publications:

Brown LL, Shelton HT, Bornside GH, Cohn I Jr. Evaluation of wound irrigation by pulsatile jet and conventional methods. Ann Surg. 1978 Feb;187(2):170-3.

Granick MS, Tenenhaus M, Knox KR, Ulm JP. Comparison of wound irrigation and tangential hydrodissection in bacterial clearance of contaminated wounds: results of a randomized, controlled clinical study. Ostomy Wound Manage. 2007 Apr;53(4):64-6, 68-70, 72.

Kuehn BM. Chronic wound care guidelines issued. JAMA. 2007 Mar 7;297(9):938-9. No abstract available.

Svoboda SJ, Bice TG, Gooden HA, Brooks DE, Thomas DB, Wenke JC. Comparison of bulb syringe and pulsed lavage irrigation with use of a bioluminescent musculoskeletal wound model. J Bone Joint Surg Am. 2006 Oct;88(10):2167-74.

Keblish DJ, DeMaio M. Early pulsatile lavage for the decontamination of combat wounds: historical review and point proposal. Mil Med. 1998 Dec;163(12):844-6.

Luedtke-Hoffmann KA, Schafer DS. Pulsed lavage in wound cleansing. Phys Ther. 2000 Mar;80(3):292-300. Review. No abstract available.

Responsible Party:	Robert Galiano, Assistant Professor of Surgery, Northwestern University
ClinicalTrials.gov Identifier:	NCT01500746 History of Changes
Other Study ID Numbers:	STU00057288
Study First Received:	December 23, 2011
Last Updated:	February 9, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

chronic wound treatment
pulse lavage
serial pulse lavage
wounds
bacterial colonization of wounds

ClinicalTrials.gov processed this record on May 21, 2013

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