Trial Outcomes & Findings for Prophylactic NPWT to Reduce SSI in Colorectal Surgery (NCT NCT03661814)

NCT ID: NCT03661814

Last Updated: 2020-12-17

Results Overview

Any type of Surgical site infection as defined by the CDC developed within the follow-up period.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: 37 days
• Results posted on: 2020-12-17

Participant Flow

Participants were recruited from August 2018 - December 2018

Participant milestones

Measure	Prevena Prevena: The negative pressure wound therapy (NPWT) device is a wound dressing with a vacuum system that can be placed over abdominal wounds, placed in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures.	Standard of Care This group will not receive the device and their surgery and clinical course will proceed as if they were not part of the study. They will receive the standard of care wound dressings.
Overall Study STARTED	2	5
Overall Study COMPLETED	2	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prophylactic NPWT to Reduce SSI in Colorectal Surgery

Baseline characteristics by cohort

Measure	Prevena n=2 Participants Prevena: The negative pressure wound therapy (NPWT) device is a wound dressing with a vacuum system that can be placed over abdominal wounds, placed in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures.	Standard of Care n=5 Participants This group will not receive the device and their surgery and clinical course will proceed as if they were not part of the study. They will receive the standard of care wound dressings.	Total n=7 Participants Total of all reporting groups
Age, Continuous	55.5 years STANDARD_DEVIATION 13.44 • n=5 Participants	68.4 years STANDARD_DEVIATION 8.38 • n=7 Participants	64.7 years STANDARD_DEVIATION 9.996 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 37 days

Any type of Surgical site infection as defined by the CDC developed within the follow-up period.

Outcome measures

Measure	Prevena n=2 Participants Prevena: The negative pressure wound therapy (NPWT) device is a wound dressing with a vacuum system that can be placed over abdominal wounds, placed in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures.	Standard of Care n=5 Participants This group will not receive the device and their surgery and clinical course will proceed as if they were not part of the study. They will receive the standard of care wound dressings.
Incidence of Surgical Site Infection	2 incidences	4 incidences

SECONDARY outcome

Timeframe: average of 7 days

Outcome measures

Measure	Prevena n=2 Participants Prevena: The negative pressure wound therapy (NPWT) device is a wound dressing with a vacuum system that can be placed over abdominal wounds, placed in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures.	Standard of Care n=5 Participants This group will not receive the device and their surgery and clinical course will proceed as if they were not part of the study. They will receive the standard of care wound dressings.
Length of Hospital Stay	7 days Standard Deviation 1.00	7.8 days Standard Deviation 2.71

SECONDARY outcome

Timeframe: up to 37 days

Number of serious adverse events developed within the follow-up period

Outcome measures

Measure	Prevena n=2 Participants Prevena: The negative pressure wound therapy (NPWT) device is a wound dressing with a vacuum system that can be placed over abdominal wounds, placed in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures.	Standard of Care n=5 Participants This group will not receive the device and their surgery and clinical course will proceed as if they were not part of the study. They will receive the standard of care wound dressings.
Number of Serious Adverse Events	0 events	0 events

Adverse Events

Prevena

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joel Bauer

Icahn School of Medicine at Mount Sinai

Phone: 914-715-4242

Email: jjb.msh@gmail.com

Results disclosure agreements

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