Wound Infection, Surgical, Obesity, Postoperative Complications
Conditions
Keywords
Obesity, Obese, surgical site infection, closed incisions, negative pressure therapy
Brief summary
The purpose of this study is to determine whether application of an incisional wound Prevena trademark (TM) dressing (applies negative pressure to wounds) in the obese (BMI ≥30) surgical patient will reduce surgical site infections (SSI) when compared to the standard of care dressing.
Detailed description
In an attempt to decrease wound infection incidence and improve healing time of open surgical wounds, vacuum assisted closure (VAC) was developed. This innovative technique provided contained controlled wound irrigation without bacterial aerosolization. A newer customizable subset of the Prevena incision Management System TM called Prevena Peel and Place TM has been released a few months ago. The new model can be cut to specific wound sizes and has a connector that can be attached to the already widely available VAC machines. The versatility and the comparability to older models of Prevena Peel and Place TM have not been tested to this date. The investigators believe that a randomized clinical trial evaluating the use of the Prevena Incision Management System TM for homecare and the use of Prevena Peel and Place TM for inpatients in special populations is warranted. Obese patients (BMI≥30) undergoing open surgery will have decreased surgical site infection rates, improved healing time, better quality of life (QOL) and lower readmission rates with use of Prevena in the post-operative management of surgical incisions.
Interventions
DEVICEPrevena
Prevena Incision Management system
DEVICEStandard Dressing
This involves standard of care dressing including but not limited to gauze.
Sponsors
Kinetic Concepts, Inc.
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) / Medical Ethics Committee (MEC) of the respective clinical site. * Patient meets the criteria for and is undergoing open surgery at Johns Hopkins Medical Institutes. * Patient with BMI≥ 30 at the time of surgery * Patient agrees to return for all required clinical follow up for the study.
Exclusion criteria
* Known allergic reaction to acrylic adhesives or silver. * Known history of intolerance to any component of Prevena Incision Management System TM. * Very fragile skin around incision site. * Bleeding disorder or refuses blood transfusion. * Malignancy or other condition limiting life expectancy to \<5 years. * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines | Up to 7 days postop | The incidence of postoperative surgical site infection (according to National Healthcare Safety Network - Center for Disease Control guidelines) in open surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Bacterial Count as Assessed by Microbacterial Count | Up to 7 days postop | Skin bacterial count after removal of either Prevena or standard dressing. A micro-bacterial swap will be performed and sent to the microbiology lab for assessing bacterial count |
| Physical Function as Assessed by Short Form Survey (SF) 36 | Up to 14 days postop | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability |
| Readmissions | Up to 30 days postop | Readmission events for the patients. |
| Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36 | Up to 14 days postop | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability |
| Other Wound Complications (Aggregate) | Up to 14 days postop | Dehiscence, seroma and hematoma. Reported as number of aggregate events. |
| Energy / Fatigue as Assessed by Short Form Survey (SF) 36 | Up to 14 days postop | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Energy and fatigue are aggregated in this section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability |
| Emotional Well Being as Assessed by Short Form Survey (SF) 36 | Up to 14 days postop | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability |
| Pain as Assessed by Short Form Survey (SF) 36 | Up to 14 days postop | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability |
| General Health as Assessed by Short Form Survey (SF) 36 | Up to 14 days postop | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability |
| Social Functioning as Assessed by Short Form Survey (SF) 36 | Up to 14 days postop | The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prevena After surgery this group will receive the Prevena device (negative pressure wound therapy).
Prevena: Prevena Incision Management system | 1 |
| Standard Dressing After surgery this group will receive standard of care dressings on their surgical wound.
Standard Dressing: This involves standard of care dressing including but not limited to gauze. | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Prevena | Standard Dressing | Total |
|---|---|---|---|
| Age, Continuous | 34 years | 45 years | 39.5 years |
| Race/Ethnicity, Customized African American | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines
The incidence of postoperative surgical site infection (according to National Healthcare Safety Network - Center for Disease Control guidelines) in open surgery
Time frame: Up to 7 days postop
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevena | Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines | 0 Surgical Site infections |
| Standard Dressing | Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines | 0 Surgical Site infections |
Secondary
Emotional Well Being as Assessed by Short Form Survey (SF) 36
The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Time frame: Up to 14 days postop
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prevena | Emotional Well Being as Assessed by Short Form Survey (SF) 36 | 60 units on a scale |
| Standard Dressing | Emotional Well Being as Assessed by Short Form Survey (SF) 36 | 60 units on a scale |
Secondary
Energy / Fatigue as Assessed by Short Form Survey (SF) 36
The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Energy and fatigue are aggregated in this section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Time frame: Up to 14 days postop
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prevena | Energy / Fatigue as Assessed by Short Form Survey (SF) 36 | 50 units on a scale |
| Standard Dressing | Energy / Fatigue as Assessed by Short Form Survey (SF) 36 | 75 units on a scale |
Secondary
General Health as Assessed by Short Form Survey (SF) 36
The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Time frame: Up to 14 days postop
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prevena | General Health as Assessed by Short Form Survey (SF) 36 | 100 units on a scale |
| Standard Dressing | General Health as Assessed by Short Form Survey (SF) 36 | 65 units on a scale |
Secondary
Other Wound Complications (Aggregate)
Dehiscence, seroma and hematoma. Reported as number of aggregate events.
Time frame: Up to 14 days postop
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevena | Other Wound Complications (Aggregate) | 0 aggregate wound complication events |
| Standard Dressing | Other Wound Complications (Aggregate) | 0 aggregate wound complication events |
Secondary
Pain as Assessed by Short Form Survey (SF) 36
The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Time frame: Up to 14 days postop
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prevena | Pain as Assessed by Short Form Survey (SF) 36 | 100 units on a scale |
| Standard Dressing | Pain as Assessed by Short Form Survey (SF) 36 | 100 units on a scale |
Secondary
Physical Function as Assessed by Short Form Survey (SF) 36
The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Time frame: Up to 14 days postop
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prevena | Physical Function as Assessed by Short Form Survey (SF) 36 | 100 units on a scale |
| Standard Dressing | Physical Function as Assessed by Short Form Survey (SF) 36 | 85 units on a scale |
Secondary
Readmissions
Readmission events for the patients.
Time frame: Up to 30 days postop
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevena | Readmissions | 0 readmission events |
| Standard Dressing | Readmissions | 0 readmission events |
Secondary
Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36
The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Time frame: Up to 14 days postop
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prevena | Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36 | 100 units on a scale |
| Standard Dressing | Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36 | 100 units on a scale |
Secondary
Skin Bacterial Count as Assessed by Microbacterial Count
Skin bacterial count after removal of either Prevena or standard dressing. A micro-bacterial swap will be performed and sent to the microbiology lab for assessing bacterial count
Time frame: Up to 7 days postop
Population: The samples were not sent to the lab
Secondary
Social Functioning as Assessed by Short Form Survey (SF) 36
The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Time frame: Up to 14 days postop
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prevena | Social Functioning as Assessed by Short Form Survey (SF) 36 | 100 units on a scale |
| Standard Dressing | Social Functioning as Assessed by Short Form Survey (SF) 36 | 100 units on a scale |