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

• ClinicalTrials.gov Identifier: NCT01500746
• Recruitment Status: Completed
• First Posted: December 28, 2011
• Results First Posted: April 14, 2014
• Last Update Posted: April 14, 2014
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Robert Galiano, Northwestern University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Chronic Wounds	Procedure: Pulse lavage treatment; Other: Dressing changes	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bedside Pulse Lavage Irrigation Project
• Study Start Date: December 2011
• Actual Primary Completion Date: October 2013
• Actual Study Completion Date: October 2013

Arms and Interventions

Arm	Intervention/treatment
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).

Outcome Measures

Primary Outcome Measures :

1. Change in Bacterial Counts [ Time Frame: 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.
2. Change in Gene Expression Analysis [ Time Frame: 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.

Secondary Outcome Measures :

1. Pain With Lavage Treatments [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Illinois

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

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.

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.

• Responsible Party: Robert Galiano, Assistant Professor of Surgery, Northwestern University
• ClinicalTrials.gov Identifier: NCT01500746
• Other Study ID Numbers: STU00057288
• First Posted: December 28, 2011
• Results First Posted: April 14, 2014
• Last Update Posted: April 14, 2014
• Last Verified: March 2014

Keywords provided by Robert Galiano, Northwestern University:

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

Additional relevant MeSH terms:

Wounds and Injuries