Patients Undergoing Hepatopancreatobiliary Surgery
Conditions
Brief summary
The purpose of this study is to compare the rate of surgical site infection between traditional wound care and negative pressure wound therapy. Wounds will be assessed 4-5 days after surgery and at the first clinic visit after surgery.
Interventions
Sterile bandages and wound coverings
DEVICENegative pressure wound therapy
The Prevena Incision Management System covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump may be used with the Prevena dressings as well in some situations to achieve negative pressure.
Sponsors
Kinetic Concepts, Inc.
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female and male patients 18 years of age or older * Scheduled for an elective surgery in either open CRS or open HPBS. This includes, but is not limited to: ileocecectomy, right hemicolectomy, extended right hemicolectomy, transverse colectomy, left hemicolectomy, sigmoidectomy, proctectomy, low anterior resection, or abdominoperineal resection gastrectomy, hepatectomy, bile duct reconstruction, duodenectomy, pancreatectomy, pancreaticoduodenectomy, or pancreatic duct reconstruction
Exclusion criteria
* The need for emergency surgery. * The need for use of only laparoscopic surgery. * Presence of bowel obstruction, strangulation, peritonitis or perforation. * The presence of local or systemic infection preoperatively. * ASA class ≥4. * Inability to provide informed consent and authorization. * Known allergy or hypersensitivity to silver. * Any clinically significant condition that, in the investigator's opinion, would significantly impair the subject's ability to comply with the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With a Surgical Site Infection | 30 days after surgery; assessed at 4-5 days and 30 days post-operation | Number and percentage of participants with at least 1 surgical site infection (SSI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Surgical Site Infections by Type | 30 days post-surgery | Each surgical site infection was classified into one of the following categories: superficial incisional, deep incisional, or organ/space (as defined by The American College of Surgeons NSQIP \[National Surgical Quality Improvement Program\] guidelines). The number of infections in each category is reported separately for both treatment arms. Some participants had multiple infections. |
| Length of Hospital Stay | Up to 62 days post-surgery | Assess (or compare) the length of hospital stay between subjects who receive standard of care and incisional V.A.C. via PIMS. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at Duke University Medical Center from December 18, 2013 to April 8, 2021 and at Indiana University from December 12, 2016 to April 8, 2021.
Participants by arm
| Arm | Count |
|---|---|
| Negative Pressure Wound Therapy The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure. | 82 |
| Conventional Wound Therapy Sterile bandages and dressings. | 82 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Device not applied | 3 | 0 |
| Overall Study | Dressing not applied in operating room | 1 | 0 |
| Overall Study | Incision < 7 cm | 2 | 0 |
| Overall Study | Surgery canceled/aborted | 9 | 5 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
| Overall Study | Wound vac turned off due to device alarm | 1 | 0 |
| Overall Study | Wrong treatment | 1 | 1 |
Baseline characteristics
| Characteristic | Conventional Wound Therapy | Total | Negative Pressure Wound Therapy |
|---|---|---|---|
| Age, Continuous | 61.1 years STANDARD_DEVIATION 12.3 | 61.6 years STANDARD_DEVIATION 11.2 | 62.1 years STANDARD_DEVIATION 10.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 Participants | 154 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 21 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 69 Participants | 134 Participants | 65 Participants |
| Sex: Female, Male Female | 44 Participants | 91 Participants | 47 Participants |
| Sex: Female, Male Male | 38 Participants | 73 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 1 / 75 |
| other Total, other adverse events | 1 / 63 | 0 / 75 |
| serious Total, serious adverse events | 0 / 63 | 0 / 75 |
Outcome results
Primary
Participants With a Surgical Site Infection
Number and percentage of participants with at least 1 surgical site infection (SSI).
Time frame: 30 days after surgery; assessed at 4-5 days and 30 days post-operation
Population: Participants who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Negative Pressure Wound Therapy | Participants With a Surgical Site Infection | 14 Participants |
| Conventional Wound Therapy | Participants With a Surgical Site Infection | 20 Participants |
p-value: 0.27t-test, 1 sided
Secondary
Length of Hospital Stay
Assess (or compare) the length of hospital stay between subjects who receive standard of care and incisional V.A.C. via PIMS.
Time frame: Up to 62 days post-surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Negative Pressure Wound Therapy | Length of Hospital Stay | 8 days |
| Conventional Wound Therapy | Length of Hospital Stay | 6 days |
Secondary
Number of Surgical Site Infections by Type
Each surgical site infection was classified into one of the following categories: superficial incisional, deep incisional, or organ/space (as defined by The American College of Surgeons NSQIP \[National Surgical Quality Improvement Program\] guidelines). The number of infections in each category is reported separately for both treatment arms. Some participants had multiple infections.
Time frame: 30 days post-surgery
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Negative Pressure Wound Therapy | Number of Surgical Site Infections by Type | Superficial Incisional | 7 infections |
| Negative Pressure Wound Therapy | Number of Surgical Site Infections by Type | Deep Incisional | 2 infections |
| Negative Pressure Wound Therapy | Number of Surgical Site Infections by Type | Organ/Space | 7 infections |
| Conventional Wound Therapy | Number of Surgical Site Infections by Type | Superficial Incisional | 7 infections |
| Conventional Wound Therapy | Number of Surgical Site Infections by Type | Deep Incisional | 6 infections |
| Conventional Wound Therapy | Number of Surgical Site Infections by Type | Organ/Space | 10 infections |