Chronic Wounds
Conditions
Keywords
chronic wound treatment, pulse lavage, serial pulse lavage, wounds, bacterial colonization of wounds
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.
Interventions
PROCEDUREPulse 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).
OTHERDressing changes
Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments).
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bacterial Counts | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain With Lavage Treatments | 4 days | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment dates extended from december 2011 to October 2013.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 4 |
| 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). | 4 |
| Total | 8 |
Baseline characteristics
| Characteristic | Lavage Arm | Moist Dressings | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 4 Participants | 7 Participants |
| Region of Enrollment United States | 4 participants | 4 participants | 8 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
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.
Time frame: Baseline and at 4 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lavage Arm | Change in Bacterial Counts | 4460 cfu/mL |
| Moist Dressings | Change in Bacterial Counts | -1030000 cfu/mL |
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.
Time frame: 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.
Time frame: 4 days