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

Chronic Wounds Clinical Trial

— PLI2  

Official title:

Bedside Pulse Lavage Irrigation Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500746
• Other study ID #: STU00057288
• Status: Completed
• Phase: N/A
• First received: December 23, 2011
• Last updated: March 10, 2014
• Start date: December 2011
• Est. completion date: October 2013

Study information

• Verified date: March 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Wounds

Intervention

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:
• Dressing changes
Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments).

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View Citation

Kuehn BM. Chronic wound care guidelines issued. JAMA. 2007 Mar 7;297(9):938-9. — View Citation

Luedtke-Hoffmann KA, Schafer DS. Pulsed lavage in wound cleansing. Phys Ther. 2000 Mar;80(3):292-300. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and at 4 days	No
Primary	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.	4 days	No
Secondary	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.	4 days	No