Trial Outcomes & Findings for Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries (NCT NCT02127164)

Last Updated: 2024-01-30

Results Overview

Surgical site infection is defined as the presence of localized inflammatory signs such as hyperthermia, erythema, tenderness, or purulent discharge that results in positive cultures, along with positive wound cultures. Surgical site can also be regarded as infected based on the individual discretion of the treating physician. Surgical sites with \>10\^5 colonization in swab will be considered contaminated.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

2 weeks

Results posted on

2024-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	"Veraflo" Device, Dakin's Solution "Veraflo" device, Dakin's solution: Veraflo device will be installed on the wound to create negative pressure after surgery. Dakin's solution will be instilled through this device into the wound at the regular intervals.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vacuum Assisted Therapy in Emergent Contaminated Abdominal Surgeries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	"Veraflo" Device, Dakin's Solution n=18 Participants "Veraflo" device, Dakin's solution: Veraflo device will be installed on the wound to create negative pressure after surgery. Dakin's solution will be instilled through this device into the wound at the regular intervals.
Age, Continuous	62.7 years STANDARD_DEVIATION 17.2 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
BMI	28.6 kg/m^2 STANDARD_DEVIATION 5.8 • n=5 Participants
Smokers	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Outcome measures

Outcome measures
Measure	"Veraflo" Device, Dakin's Solution n=18 Participants "Veraflo" device, Dakin's solution: Veraflo device will be installed on the wound to create negative pressure after surgery. Dakin's solution will be instilled through this device into the wound at the regular intervals.
Rate of Surgical Site Infection	5 Participants

SECONDARY outcome

Timeframe: 1 week

The Wong-Baker Faces Pain Rating scale is used to grade pain related to the presence/manipulation of the device. The Wong-Baker scale range is from 0 (No Hurt) to 10 (Hurts Worst) with numbers increasing by 2 (0, 2, 4, 6, 8, 10) and associated face images showing increased pain and sadness. Higher scores indicate increased pain, a worse outcome.

Outcome measures

Outcome measures
Measure	"Veraflo" Device, Dakin's Solution n=18 Participants "Veraflo" device, Dakin's solution: Veraflo device will be installed on the wound to create negative pressure after surgery. Dakin's solution will be instilled through this device into the wound at the regular intervals.
Wong-Baker Faces Pain Rating Scale	6 pain score Interval 4.0 to 6.0

Adverse Events

"Veraflo" Device, Dakin's Solution

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

Andrew Tang, MD

University of Arizona

Phone: 520-626-5056

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place