Surgical Wound Infection
Conditions
Keywords
Negative Pressure Wound Therapy, Colorectal Surgery, Prevena, Surgical Site Infection
Brief summary
The purpose of this study is to see if the Negative Pressure Wound Therapy (NPWT) system is effective and safe for the prevention of superficial and deep incisional surgical site infections (SSI) in high risk patients within 30 days after elective colorectal surgery. It has been shown that patients with an IBD, patients undergoing a reoperation or patients with certain comorbidities are at a higher risk of developing an SSI. The NPWT device is a wound dressing with a vacuum system that can be placed over abdominal wounds. The study will include up to 400 patients at this single site, where these high risk patients will be randomized to receive either one of two arms. The first arm involves the placement of the NPWT device in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures. The device would then be left on for 5 days. The second arm would be standard of care and would entail routine postoperative protocols. Subjects will then be seen once at a 30 day (± 7 days) follow-up visit to assess for the development of SSIs.
Interventions
DEVICEPrevena
The 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.
Sponsors
Kinetic Concepts, Inc.
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Two cohorts. Experimental group receives the study device and the control group receives the standard of care (No device). Patients are randomized to either group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ages 18-80 * patients who will undergo an open or laparoscopic-assisted clean/contaminated colorectal surgical procedure. * Patients must either have an inflammatory bowel disease, undergoing reoperation within 30 days, or have two or more of the following risk factors: presence of an ostomy, type II diabetes, BMI greater than 30, immunosuppression, malnutrition, current smoker, chronic kidney disease (creatinine \> 1.2), and disseminated cancer.
Exclusion criteria
* patients currently enrolled in another interventional clinical trial, * patients with a BMI less than 20, patients with a current abdominal abscess or infection (including a known urinary tract infection), * patients allergic to or hypersensitive to silver, patients planning to undergo a second colorectal surgical procedure (e.g., colostomy or ileostomy takedown) or any other general surgery in less than 30 days of index-surgery, * any patient in which the planned surgery would include: i) placement of a stoma in the principal incision; ii) placement of a drain into the supra-peritoneal fascia space that emerges through the principal incision; iv) placement of a drain into the intraperitoneal space that emerges through the principal incision; and v) supplementation of any of the irrigation fluid with antibiotic or antiseptic drugs, * patients with healing disorders, * pregnant women, * prisoners, or * any patient that is deemed unsuitable for the study by the Principal Investigator or the operating surgeon/Co-Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Surgical Site Infection | 37 days | Any type of Surgical site infection as defined by the CDC developed within the follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | average of 7 days | — |
| Number of Serious Adverse Events | up to 37 days | Number of serious adverse events developed within the follow-up period |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from August 2018 - December 2018
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 5 |
| Total | 7 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Prevena |
|---|---|---|---|
| Age, Continuous | 68.4 years STANDARD_DEVIATION 8.38 | 64.7 years STANDARD_DEVIATION 9.996 | 55.5 years STANDARD_DEVIATION 13.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 7 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 5 |
| other Total, other adverse events | 0 / 2 | 0 / 5 |
| serious Total, serious adverse events | 0 / 2 | 0 / 5 |
Outcome results
Primary
Incidence of Surgical Site Infection
Any type of Surgical site infection as defined by the CDC developed within the follow-up period.
Time frame: 37 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevena | Incidence of Surgical Site Infection | 2 incidences |
| Standard of Care | Incidence of Surgical Site Infection | 4 incidences |
Secondary
Length of Hospital Stay
Time frame: average of 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prevena | Length of Hospital Stay | 7 days | Standard Deviation 1 |
| Standard of Care | Length of Hospital Stay | 7.8 days | Standard Deviation 2.71 |
Secondary
Number of Serious Adverse Events
Number of serious adverse events developed within the follow-up period
Time frame: up to 37 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevena | Number of Serious Adverse Events | 0 events |
| Standard of Care | Number of Serious Adverse Events | 0 events |