Trial Outcomes & Findings for Prophylactic Application of an Incisional Wound Vac to Prevent Wound Complications in Obese Spine Surgery Patients (NCT NCT02926924)

NCT ID: NCT02926924

Last Updated: 2025-04-11

Results Overview

Count of Patients with Post operative infection requiring return to operating room or prolonged treatment of antibiotics

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 68 participants
• Primary outcome timeframe: 6 weeks post surgery
• Results posted on: 2025-04-11

Participant Flow

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.

Participant milestones

Measure	Standard Dressing Standard Dressing Standard Dressing: standard dressing with drain tube and bandage	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.
Overall Study STARTED	19	21
Overall Study S.D. First Then After a Subsequent Surgery Participated in WV Without Reconsent or Re-randomization	1	0
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Standard Dressing Standard Dressing Standard Dressing: standard dressing with drain tube and bandage	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.
Overall Study withdrawal - reason unknown	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Standard Dressing n=19 Participants Standard Dressing: standard dressing with drain tube and bandage	Wound Vac n=21 Participants 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.	Total n=40 Participants Total of all reporting groups
Age, Continuous	55 years n=19 Participants	56 years n=21 Participants	55.2 years n=40 Participants
Sex: Female, Male Female	13 Participants n=19 Participants	12 Participants n=21 Participants	25 Participants n=40 Participants
Sex: Female, Male Male	6 Participants n=19 Participants	9 Participants n=21 Participants	15 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	19 Participants n=19 Participants	21 Participants n=21 Participants	40 Participants n=40 Participants

PRIMARY outcome

Timeframe: 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.

Count of Patients with Post operative infection requiring return to operating room or prolonged treatment of antibiotics

Outcome measures

Measure	Standard Dressing n=19 Participants Standard Dressing Standard Dressing: standard dressing with drain tube and bandage	Wound Vac n=22 Participants 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.
Count of Patients With Post Operative Infection readmission	4 Participants	2 Participants
Count of Patients With Post Operative Infection prolonged antibiotic use	5 Participants	3 Participants

Adverse Events

Standard Dressing

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Wound Vac

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Standard Dressing n=19 participants at risk Standard Dressing Standard Dressing: standard dressing with drain tube and bandage	Wound Vac n=22 participants at risk 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.
Surgical and medical procedures Readmission to Hospital	21.1% 4/19 • 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.	9.1% 2/22 • 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.

Other adverse events

Measure	Standard Dressing n=19 participants at risk Standard Dressing Standard Dressing: standard dressing with drain tube and bandage	Wound Vac n=22 participants at risk 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.
Infections and infestations prolonged antibiotic use required	26.3% 5/19 • 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.	13.6% 3/22 • 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.

Additional Information

Rakesh Patel

University of Michigan

Phone: 734 615-2002

Email: rakeshpa@med.umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place