Trial Outcomes & Findings for Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2) (NCT NCT00829621)

Results Overview

Presence of BMP-2 in effluent collected in IVAC canister

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

12-hours, 24-hours, 36-hours, and 48-hours after IVAC application

Results posted on

2016-11-07

Participant milestones
Measure	75 mmHg IVAC suction 75 mmHg 75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.	125 mmHg IVAC suction 125 mmHg 125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.
Overall Study STARTED	8	12
Overall Study COMPLETED	4	8
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal
Measure	75 mmHg IVAC suction 75 mmHg 75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.	125 mmHg IVAC suction 125 mmHg 125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.
Overall Study Death	1	0
Overall Study Lost to Follow-up	3	4

Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)

Baseline characteristics by cohort
Measure	75 mmHg n=8 Participants IVAC suction 75 mmHg 75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.	125 mmHg n=12 Participants IVAC suction 125 mmHg 125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.	Total n=20 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 17.5 • n=5 Participants	42.1 years STANDARD_DEVIATION 16.6 • n=7 Participants	43 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants

Timeframe: 12-hours, 24-hours, 36-hours, and 48-hours after IVAC application

Presence of BMP-2 in effluent collected in IVAC canister

Outcome measures
Measure	75 mmHg n=8 Participants IVAC suction 75 mmHg 75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.	125 mmHg n=12 Participants IVAC suction 125 mmHg 125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.
Presence of BMP-2 in Effluent Collected in IVAC Canister	6 participants	11 participants

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	75 mmHg n=8 participants at risk IVAC suction 75 mmHg 75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.	125 mmHg n=12 participants at risk IVAC suction 125 mmHg 125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.
Renal and urinary disorders died secondary to chronic renal failure	12.5% 1/8	0.00% 0/12
Respiratory, thoracic and mediastinal disorders pulmonary embolis	0.00% 0/8	8.3% 1/12
Musculoskeletal and connective tissue disorders nonunion	0.00% 0/8	8.3% 1/12
Infections and infestations wound infection	12.5% 1/8	8.3% 1/12

Other adverse events
Measure	75 mmHg n=8 participants at risk IVAC suction 75 mmHg 75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use.	125 mmHg n=12 participants at risk IVAC suction 125 mmHg 125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use.
Musculoskeletal and connective tissue disorders delayed union	12.5% 1/8	0.00% 0/12

University of Missouri, Department of Orthopaedics

Phone: 573-882-6562