Trial Outcomes & Findings for Vacuum-Assisted Dressings (V-AD) in the Management of Open Chest Wounds (NCT NCT02803164)

NCT ID: NCT02803164

Last Updated: 2021-09-29

Results Overview

The total number of days of receiving NWPT

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: 12 month follow up
• Results posted on: 2021-09-29

Participant Flow

Participant milestones

Measure	Intervention Treatment of wound with Vacuum-assisted dressing. Wound Vacuum-assisted dressing: Management of chronic open chest wounds with V-AD assisted dressing.	Historical Control Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques
Overall Study STARTED	10	11
Overall Study COMPLETED	10	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention n=10 Participants Treatment of wound with Vacuum-assisted dressing. Wound Vacuum-assisted dressing: Management of chronic open chest wounds with V-AD assisted dressing.	Control Group n=11 Participants Historical chest wound treatment.	Total n=21 Participants Total of all reporting groups
Age, Continuous	61 years n=10 Participants	62 years n=11 Participants	62 years n=21 Participants
Sex: Female, Male Female	7 Participants n=10 Participants	1 Participants n=11 Participants	8 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=10 Participants	10 Participants n=11 Participants	13 Participants n=21 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 participants n=10 Participants	11 participants n=11 Participants	21 participants n=21 Participants

PRIMARY outcome

Timeframe: 12 month follow up

Population: Data not collected or analyzed for the Historical Control arm. This arm did not receive the NWPT.

The total number of days of receiving NWPT

Outcome measures

Measure	Intervention n=10 Participants Treatment of wound with Vacuum-assisted dressing. Wound Vacuum-assisted dressing: Management of chronic open chest wounds with V-AD assisted dressing.	Historical Control Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques.
Duration of Negative Pressure Wound Therapy (NWPT)	8 Days Interval 2.0 to 29.0	—

SECONDARY outcome

Timeframe: 12 months

The total number of days to wound closure

Outcome measures

Measure	Intervention n=10 Participants Treatment of wound with Vacuum-assisted dressing. Wound Vacuum-assisted dressing: Management of chronic open chest wounds with V-AD assisted dressing.	Historical Control n=11 Participants Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques.
Wound Closure	7 Days Interval 4.0 to 49.0	18 Days Interval 4.0 to 179.0

SECONDARY outcome

Timeframe: 12 months

The total number of days in hospital

Outcome measures

Measure	Intervention n=10 Participants Treatment of wound with Vacuum-assisted dressing. Wound Vacuum-assisted dressing: Management of chronic open chest wounds with V-AD assisted dressing.	Historical Control n=11 Participants Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques.
Length of Hospital Stay	6 Days Interval 1.0 to 43.0	25 Days Interval 3.0 to 152.0

Adverse Events

Intervention

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Historical Control

Serious events: 11 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Measure	Intervention n=10 participants at risk Treatment of wound with Vacuum-assisted dressing. Wound Vacuum-assisted dressing: Management of chronic open chest wounds with V-AD assisted dressing.	Historical Control n=11 participants at risk Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques
Infections and infestations Sepsis	10.0% 1/10 • Number of events 1 • 1 year	63.6% 7/11 • Number of events 7 • 1 year
Cardiac disorders Major cardiac event	0.00% 0/10 • 1 year	9.1% 1/11 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Air Embolism	0.00% 0/10 • 1 year	9.1% 1/11 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Reintubation	0.00% 0/10 • 1 year	18.2% 2/11 • Number of events 2 • 1 year
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	0.00% 0/10 • 1 year	9.1% 1/11 • Number of events 1 • 1 year
Renal and urinary disorders Acute kidney failure	0.00% 0/10 • 1 year	9.1% 1/11 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Hemothorax	10.0% 1/10 • Number of events 1 • 1 year	9.1% 1/11 • Number of events 1 • 1 year

Other adverse events

Measure	Intervention n=10 participants at risk Treatment of wound with Vacuum-assisted dressing. Wound Vacuum-assisted dressing: Management of chronic open chest wounds with V-AD assisted dressing.	Historical Control n=11 participants at risk Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques
Cardiac disorders Atrial fibrillation	0.00% 0/10 • 1 year	45.5% 5/11 • Number of events 5 • 1 year
Respiratory, thoracic and mediastinal disorders pneumonia	10.0% 1/10 • Number of events 1 • 1 year	27.3% 3/11 • Number of events 3 • 1 year
General disorders Wound dehiscence	10.0% 1/10 • Number of events 1 • 1 year	0.00% 0/11 • 1 year

Additional Information

Dr. Mathew Thomas

Mayo Clinic

Phone: 904-953-2000

Email: thomas.mathew@mayo.edu

Results disclosure agreements

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