Clinical trial NCT01500746: Evaluation of the Effectiveness of Daily Pulse Lavage Therapy in Chronic Wounds
Official title: Bedside Pulse Lavage Irrigation Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Wounds
Keywords: chronic wound treatment
pulse lavage
serial pulse lavage
wounds
bacterial colonization of wounds
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2011-12-28
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in Bacterial Counts
timeFrame: Baseline and at 4 days
measure: Change in Gene Expression Analysis
timeFrame: 4 days
Secondary outcomes:
measure: Pain With Lavage Treatments
timeFrame: 4 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Robert D Galiano, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: Luedtke-Hoffmann KA, Schafer DS. Pulsed lavage in wound cleansing. Phys Ther. 2000 Mar;80(3):292-300. No abstract available.