Trial Outcomes & Findings for Prevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery (NCT NCT02836990)

Last Updated: 2020-12-28

Results Overview

The primary effectiveness endpoint is 30 day healing of the randomized groin incision, with any wound infection or failure to heal. Szilagyi wound infection grade quantified on an ordinal scale will be used to assess the healing (None, Grade I: Infection contained to the dermis, Grade II: Infection extending into the subcutaneous tissue but the arterial graft is not involved, Grade III: Infection of the arterial graft or native vessel underlying the incision). Healing is assessed by complete sealing of the incision with no residual separation or drainage. All of the incisions were primarily closed, so a healed incision would have no gaps between the skin edges. This is a visual inspection. Szilagi is an assessment of the grade of wound infection for those that did not heal. It is well recognized and published, and noted as above for patients with vascular exposure.

Recruitment status

COMPLETED

Study phase

Target enrollment

105 participants

Primary outcome timeframe

30 days

Results posted on

2020-12-28

Participant Flow

Participants were recruited from UBMD Vascular Surgery Office and were consented at the time of surgery at Buffalo General Medical Center between 2016 and 2019.

Participant milestones

Participant milestones
Measure	Prevena Prevena Incision Management System for vascular surgical groin wounds Prevena Incision Management System: A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections	Dermabond Dermabond for vascular surgical groin wounds Dermabond: A surgical skin adhesive used to prevent surgical wound infections
Overall Study STARTED	50	55
Overall Study COMPLETED	50	55
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevena™ vs Dermabond in Groin Wound Infections in Vascular Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prevena n=46 Participants Prevena Incision Management System for vascular surgical groin wounds Prevena Incision Management System: A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections	Dermabond n=55 Participants Dermabond for vascular surgical groin wounds Dermabond: A surgical skin adhesive used to prevent surgical wound infections	Total n=101 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=113 Participants	20 Participants n=163 Participants	36 Participants n=160 Participants
Age, Categorical >=65 years	30 Participants n=113 Participants	35 Participants n=163 Participants	65 Participants n=160 Participants
Age, Continuous	68 years STANDARD_DEVIATION 10 • n=113 Participants	68 years STANDARD_DEVIATION 12 • n=163 Participants	68 years STANDARD_DEVIATION 11 • n=160 Participants
Sex: Female, Male Female	21 Participants n=113 Participants	15 Participants n=163 Participants	36 Participants n=160 Participants
Sex: Female, Male Male	25 Participants n=113 Participants	40 Participants n=163 Participants	65 Participants n=160 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Asian	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Black or African American	10 Participants n=113 Participants	4 Participants n=163 Participants	14 Participants n=160 Participants
Race (NIH/OMB) White	36 Participants n=113 Participants	51 Participants n=163 Participants	87 Participants n=160 Participants
Race (NIH/OMB) More than one race	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Region of Enrollment United States	46 participants n=113 Participants	55 participants n=163 Participants	101 participants n=160 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Prevena n=46 Participants Prevena Incision Management System for vascular surgical groin wounds Prevena Incision Management System: A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections	Dermabond n=55 Participants Dermabond for vascular surgical groin wounds Dermabond: A surgical skin adhesive used to prevent surgical wound infections
Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond	41 Participants	54 Participants

SECONDARY outcome

Timeframe: 30 days

Population: not analyzed as the primary outcome did not demonstrate improved outcomes, and the device being tested, wound vacuum, was more expensive. Had outcomes clinically been improved, financial assessment would have determined whether cost of infection outweighed cost of device.

Comparison of cost of treatment between the two arms

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Physician office visits for diagnosis of Infection or visiting nurse visits for diagnosis of infection ONLY were assessed.

Outcome measures

Outcome measures
Measure	Prevena n=46 Participants Prevena Incision Management System for vascular surgical groin wounds Prevena Incision Management System: A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections	Dermabond n=55 Participants Dermabond for vascular surgical groin wounds Dermabond: A surgical skin adhesive used to prevent surgical wound infections
Number of Visiting Nurses Home Visits and Physician Office Visits to Assess/Treat Wound Infection	7 Participants	7 Participants

Adverse Events

Prevena

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Dermabond

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Prevena n=46 participants at risk Prevena Incision Management System for vascular surgical groin wounds Prevena Incision Management System: A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections	Dermabond n=55 participants at risk Dermabond for vascular surgical groin wounds Dermabond: A surgical skin adhesive used to prevent surgical wound infections
Infections and infestations Reoperation for groin complication	6.5% 3/46 • Number of events 5 • 40 days from time of surgery	3.6% 2/55 • Number of events 2 • 40 days from time of surgery

Other adverse events

Adverse event data not reported

Additional Information

Dr Linda Harris

University at Buffalo, SUNY

Phone: 7168594207

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place