Chronic WoundsPLI2NCT01500746
Evaluation of the Effectiveness of Daily Pulse Lavage Therapy in Chronic Wounds
A study testing Pulse lavage treatment and Dressing changes in people with Chronic Wounds, run by Northwestern University at 1 site in United States.
Trial summary
This study evaluates the effectiveness of pulse lavage therapy in decreasing bacterial counts in chronic wounds. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Wounds
- What is being tested?
- Pulse lavage treatment and Dressing changes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Bedside Pulse Lavage Irrigation Project
This study evaluates the effectiveness of pulse lavage therapy in decreasing bacterial counts in chronic wounds.
Read the 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.
- Conditions
- Chronic Wounds
- Being tested
- Pulse lavage treatment, Dressing changes
- Keywords
- chronic wound treatment, pulse lavage, serial pulse lavage, wounds, bacterial colonization of wounds
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse lavage treatmentProcedure or surgery
Also called Pulsed lavage (Stryker Pulsavac Plus), Wound containment apparatus
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).
Dressing changesOther
Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Pulse lavage treatment |
| 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. Receives: Other: Dressing changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 days
Secondary outcomes (1)
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.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic WoundsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Galiano, Northwestern University
- Investigators
- Robert D Galiano, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500746
- Sponsor's protocol ID
- STU00057288
- Acronym
- PLI2
- Status last verified
- Mar 2014
- First submitted
- 23 Dec 2011
- Last updated
- 14 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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. doi: 10.1097/00000658-197802000-00013.
PubMed 343735Granick 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.
PubMed 17449917Kuehn BM. Chronic wound care guidelines issued. JAMA. 2007 Mar 7;297(9):938-9. doi: 10.1001/jama.297.9.938. No abstract available.
PubMed 17341696Svoboda 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.
PubMed 17015593Keblish 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.
PubMed 9866365Luedtke-Hoffmann KA, Schafer DS. Pulsed lavage in wound cleansing. Phys Ther. 2000 Mar;80(3):292-300. No abstract available.
PubMed 10696155
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Pulse Lavage Irrigation Project
- ClinicalTrials.gov ID
- NCT01500746
- Acronym / sponsor ID
- PLI2 / STU00057288
- Conditions
- Chronic Wounds
- Keywords
- chronic wound treatment, pulse lavage, serial pulse lavage, wounds, bacterial colonization of wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 28 Dec 2011 (estimated)
- Results
- Posted 14 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lavage arm | Experimental | Procedure: Pulse lavage treatmentThis 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. |
| Moist dressings | Active comparator | Other: Dressing changesThis 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulse lavage treatmentAlso: Pulsed lavage (Stryker Pulsavac Plus), Wound containment apparatusA 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). | Procedure or surgery | Lavage arm |
| Dressing changesWounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments). | Other | Moist dressings |
Primary outcome
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.
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.
1 secondary outcome
Pain With Lavage Treatments
Time frame: 4 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 343735Brown 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.
- Background: PubMed 17449917Granick 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.
- Background: PubMed 17341696Kuehn BM. Chronic wound care guidelines issued. JAMA. 2007 Mar 7;297(9):938-9. doi: 10.1001/jama.297.9.938. No abstract available.
- Background: PubMed 17015593Svoboda 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.
- Background: PubMed 9866365Keblish 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.
- Background: PubMed 10696155Luedtke-Hoffmann KA, Schafer DS. Pulsed lavage in wound cleansing. Phys Ther. 2000 Mar;80(3):292-300. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D Galiano, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse lavage treatment and Dressing changes in people with Chronic Wounds, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bacterial Counts (time frame: Baseline and at 4 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01500746, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.