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

Primary Purpose

Chronic Wounds

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulse lavage treatment
Dressing changes
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Wounds focused on measuring chronic wound treatment, pulse lavage, serial pulse lavage, wounds, bacterial colonization of wounds

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Northwestern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lavage arm

Moist dressings

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 23, 2011
Last Updated
March 10, 2014
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01500746
Brief Title
Evaluation of the Effectiveness of Daily Pulse Lavage Therapy in Chronic Wounds
Acronym
PLI2
Official Title
Bedside Pulse Lavage Irrigation Project
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Wounds
Keywords
chronic wound treatment, pulse lavage, serial pulse lavage, wounds, bacterial colonization of wounds

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lavage arm
Arm Type
Experimental
Arm 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.
Arm Title
Moist dressings
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Pulse lavage treatment
Other Intervention Name(s)
Pulsed lavage (Stryker Pulsavac Plus), Wound containment apparatus
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Dressing changes
Intervention Description
Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments).
Primary Outcome Measure Information:
Title
Change in Bacterial Counts
Description
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
Title
Change in Gene Expression Analysis
Description
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 Outcome Measure Information:
Title
Pain With Lavage Treatments
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D Galiano, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
343735
Citation
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. doi: 10.1097/00000658-197802000-00013.
Results Reference
background
PubMed Identifier
17449917
Citation
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.
Results Reference
background
PubMed Identifier
17341696
Citation
Kuehn BM. Chronic wound care guidelines issued. JAMA. 2007 Mar 7;297(9):938-9. doi: 10.1001/jama.297.9.938. No abstract available.
Results Reference
background
PubMed Identifier
17015593
Citation
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. doi: 10.2106/JBJS.E.00248.
Results Reference
background
PubMed Identifier
9866365
Citation
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.
Results Reference
background
PubMed Identifier
10696155
Citation
Luedtke-Hoffmann KA, Schafer DS. Pulsed lavage in wound cleansing. Phys Ther. 2000 Mar;80(3):292-300. No abstract available.
Results Reference
background

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

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