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This study evaluates the effectiveness of pulse lavage therapy in decreasing bacterial counts in chronic wounds.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lavage arm | Experimental | 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. |
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| Moist dressings | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse lavage treatment | Procedure | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert D Galiano, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 343735 | Background | 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. | |
| 17449917 | Background | 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. |
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Recruitment dates extended from december 2011 to October 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | cfu/mL | Baseline and at 4 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elliot Hirsch | Northwestern University | 312-695-6022 | elliot-hirsch@md.northwestern.edu |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Dressing changes | Other | Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments). |
|
| 17341696 | Background | 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. |
| 17015593 | Background | 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. |
| 9866365 | Background | 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. |
| 10696155 | Background | Luedtke-Hoffmann KA, Schafer DS. Pulsed lavage in wound cleansing. Phys Ther. 2000 Mar;80(3):292-300. No abstract available. |
| BG001 | 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. Dressing changes: Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments). |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Northwestern Memorial Hospital, Chicago, IL | Number | participants |
|
| OG001 | 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. |
|
|
| 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. | Not Posted | 4 days |
| 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. | Not Posted | 4 days |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 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. Dressing changes: Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments). | 0 | 4 | 0 | 4 |
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