Spine Surgery, Wounds Vac
Conditions
Brief summary
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.
Interventions
DEVICEWound 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.
OTHERStandard Dressing
standard dressing with drain tube and bandage
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be scheduled to have posterior spine surgery (inpatient procedures only). * Have a BMI greater than or equal to 35.
Exclusion criteria
* BMI less than 35 * Previous spine infection * Intraoperative dural tear
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Patients With Post Operative Infection | 6 weeks post surgery | Count of Patients with Post operative infection requiring return to operating room or prolonged treatment of antibiotics |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Standard Dressing Standard Dressing: standard dressing with drain tube and bandage | 19 |
| 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. | 21 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | withdrawal - reason unknown | 0 | 1 |
Baseline characteristics
| Characteristic | Wound Vac | Total | Standard Dressing |
|---|---|---|---|
| Age, Continuous | 56 years | 55.2 years | 55 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 21 Participants | 40 Participants | 19 Participants |
| Sex: Female, Male Female | 12 Participants | 25 Participants | 13 Participants |
| Sex: Female, Male Male | 9 Participants | 15 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 22 |
| other Total, other adverse events | 5 / 19 | 3 / 22 |
| serious Total, serious adverse events | 4 / 19 | 2 / 22 |
Outcome results
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
Time frame: 6 weeks post surgery
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Dressing | Count of Patients With Post Operative Infection | readmission | 4 Participants |
| Standard Dressing | Count of Patients With Post Operative Infection | prolonged antibiotic use | 5 Participants |
| Wound Vac | Count of Patients With Post Operative Infection | readmission | 2 Participants |
| Wound Vac | Count of Patients With Post Operative Infection | prolonged antibiotic use | 3 Participants |