Trial Outcomes & Findings for Incisional Negative Pressure Wound Therapy (NCT NCT01759381)

Results Overview

The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

3 months

Results posted on

2015-07-02

Participant milestones
Measure	No Negative Pressure Wound Therapy Device This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.	NPWT Arm Therapy This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery. Negative pressure wound therapy (NPWT)
Overall Study STARTED	8	11
Overall Study COMPLETED	7	11
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal
Measure	No Negative Pressure Wound Therapy Device This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.	NPWT Arm Therapy This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery. Negative pressure wound therapy (NPWT)
Overall Study Death	1	0

Incisional Negative Pressure Wound Therapy

Baseline characteristics by cohort
Measure	No Negative Pressure Wound Therapy Device n=8 Participants This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.	NPWT Arm Therapy n=11 Participants This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery. Negative pressure wound therapy (NPWT)	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=39 Participants	9 Participants n=41 Participants	13 Participants n=35 Participants
Age, Categorical >=65 years	4 Participants n=39 Participants	2 Participants n=41 Participants	6 Participants n=35 Participants
Sex: Female, Male Female	7 Participants n=39 Participants	7 Participants n=41 Participants	14 Participants n=35 Participants
Sex: Female, Male Male	1 Participants n=39 Participants	4 Participants n=41 Participants	5 Participants n=35 Participants
Region of Enrollment United States	8 participants n=39 Participants	11 participants n=41 Participants	19 participants n=35 Participants

Timeframe: 3 months

The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period.

Outcome measures
Measure	No Negative Pressure Wound Therapy Device n=7 Participants This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.	NPWT Arm Therapy n=11 Participants This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery. Negative pressure wound therapy (NPWT)
Number of Participants With Post-operative Infection (NPWT)	1 participants	2 participants

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	No Negative Pressure Wound Therapy Device n=8 participants at risk This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.	NPWT Arm Therapy n=11 participants at risk This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery. Negative pressure wound therapy (NPWT)
Nervous system disorders Death	12.5% 1/8 • Number of events 1 • pre-op - 3 months	0.00% 0/11 • pre-op - 3 months

Adverse event data not reported

Duke

Phone: 919-943-1564