Trial Outcomes & Findings for Wound Vac Bandage Comparison After Spinal Fusion (NCT NCT03000010)

Results Overview

Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

2 years

Results posted on

2021-06-28

Participant milestones
Measure	Incisional Wound Vac We will attach sponges and a suction tube to the incision after surgery. We will leave it on for 72 hours. From then on, patients will get the care that patients normally get after spinal fusion surgery. Incisional Wound Vac	Normal Gauze Bandage Group We will cover patients incision with regular gauze bandages. These are the bandages that patients normally get after spinal fusion surgery. They will be left on for 72 hours. Standard Bandage
Overall Study STARTED	21	20
Overall Study COMPLETED	21	20
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Incisional Wound Vac n=21 Participants We will attach sponges and a suction tube to the incision after surgery. We will leave it on for 72 hours. From then on, patients will get the care that patients normally get after spinal fusion surgery. Incisional Wound Vac	Normal Gauze Bandage Group n=20 Participants We will cover patients incision with regular gauze bandages. These are the bandages that patients normally get after spinal fusion surgery. They will be left on for 72 hours. Standard Bandage	Total n=41 Participants Total of all reporting groups
Age, Continuous	13.5 years STANDARD_DEVIATION 1.6 • n=21 Participants	12.6 years STANDARD_DEVIATION 2.7 • n=20 Participants	13 years STANDARD_DEVIATION 2.3 • n=41 Participants
Sex: Female, Male Female	5 Participants n=21 Participants	9 Participants n=20 Participants	14 Participants n=41 Participants
Sex: Female, Male Male	16 Participants n=21 Participants	11 Participants n=20 Participants	27 Participants n=41 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

Timeframe: 2 years

Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery

Outcome measures
Measure	Incisional Wound Vac n=21 Participants We will attach sponges and a suction tube to the incision after surgery. We will leave it on for 72 hours. From then on, patients will get the care that patients normally get after spinal fusion surgery. Incisional Wound Vac	Normal Gauze Bandage Group n=20 Participants We will cover patients incision with regular gauze bandages. These are the bandages that patients normally get after spinal fusion surgery. They will be left on for 72 hours. Standard Bandage
Number of Participants With Wound Dehiscence or Infection	0 Participants	0 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Adverse event data not reported

Adverse event data not reported

University of Michigan

Phone: 734-936-5715