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This is a prospective randomized study evaluating the use of a prophylactic incision wound vac dressing, applied in the OR, on patients undergoing posterior spine surgery with a BMI>35. Patients are randomized in the operating room to normal postoperative dressing vs. vac dressing. The vac dressing would be left on for 72 hours postoperatively. In the interim, the patients' postoperative care can proceed as usual. Our primary outcomes will be antibiotics or return trip needed to the operating room for wound related complications.
The patients only intervention would be the application of an incisional wound vac. The will be no change in the patients postoperative protocol otherwise. This procedure is noninvasive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wound Vac | Active Comparator | Wound vac |
|
| Standard Dressing | Active Comparator | Standard Dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wound Vac | Device | a therapeutic technique using a vacuum dressing to promote healing in acute or chronic wounds and enhance healing of first and second degree burns. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Count of Patients With Post Operative Infection | Count of Patients with Post operative infection requiring return to operating room or prolonged treatment of antibiotics | 6 weeks post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rakesh Patel, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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Of 68 participants consented, 2 were excluded by PI decision for coming from another site and their data is not accessible for inclusion in any analyses. Of the remaining 66, data for 26 was irretrievably lost and cannot be provided. One participant in the standard group subsequently participated in the wound vac group (without an additional consent required), as is shown by the milestone listed below.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Dressing | Standard Dressing Standard Dressing: standard dressing with drain tube and bandage |
| FG001 | Wound Vac | Wound vac Wound Vac: a therapeutic technique using a vacuum dressing to promote healing in acute or chronic wounds and enhance healing of first and second degree burns. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
28 participants' data (2 from elsewhere and 26 from Michigan) was lost and their baseline data is not included. The individual who began in the standard dressing group and then subsequently participated in the wound vac group is only represented in the standard dressing group for baseline characteristics analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Dressing | Standard Dressing: standard dressing with drain tube and bandage |
| BG001 | Wound Vac | Wound vac Wound Vac: a therapeutic technique using a vacuum dressing to promote healing in acute or chronic wounds and enhance healing of first and second degree burns. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Count of Patients With Post Operative Infection | Count of Patients with Post operative infection requiring return to operating room or prolonged treatment of antibiotics | 22 are shown in the wound vac arm because of the one participant whose first surgery was with standard dressing and subsequently participated in the wound vac arm after a second surgery. | Posted | Count of Participants | Participants | 6 weeks post surgery |
|
6 weeks after surgery
The only adverse events that were collected were extended antibiotic use and rehospitalization. So the 0s listed in "other adverse events" is simply a statement of what data was collected, but not an assurance that no non-serious adverse events occurred.
Systematic assessment was performed simply by a records review pulling for those two items: extended antibiotic use and rehospitalization.
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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 | Standard Dressing | Standard Dressing Standard Dressing: standard dressing with drain tube and bandage |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Readmission to Hospital | Surgical and medical procedures | Systematic Assessment | required return trip to the operating room for what was found to be a suture abscess |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| prolonged antibiotic use required | Infections and infestations | Systematic Assessment |
This small study was intended to be a pilot. Without a larger population, results should not be seen as generalizable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rakesh Patel | University of Michigan | 734 615-2002 | rakeshpa@med.umich.edu |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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|
| Standard Dressing | Other | standard dressing with drain tube and bandage |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 0 |
| 19 |
| 4 |
| 19 |
| 5 |
| 19 |
| EG001 | Wound Vac | Wound vac Wound Vac: a therapeutic technique using a vacuum dressing to promote healing in acute or chronic wounds and enhance healing of first and second degree burns. | 0 | 22 | 2 | 22 | 3 | 22 |
|
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