Surgical Wound Infection, Cesarean Section
Conditions
Brief summary
The Prophylactic Negative Pressure Wound Therapy in Obese Women at Cesarean Trial is a large pragmatic multi-center randomized clinical trial designed to evaluate the effectiveness, safety and cost-effectiveness of prophylactic negative pressure wound therapy (NPWT) - a closed, sealed system that applies negative pressure to the wound surface via a single-use, battery-powered, portable device - to decrease surgical site infections (SSIs) in obese women.
Detailed description
Experimental evidence suggests that NPWT promotes wound healing by removing exudate, approximating the wound edges, and reducing bacterial contamination. Obesity (body mass index \[BMI\] ≥30kg/m2) increases the risk for both cesarean delivery and SSIs compared to non-obese women. The increased risk of SSIs is in part due to the increased thickness of the subcutaneous space, allowing collection of exudates and increasing tension on wound edges, promoting the growth of bacteria, and leading to wound infection and breakdown. Thus, prophylactic NPWT may be particularly effective in this patient population. During the 5-year project period, investigators from 4 collaborating perinatal centers in the United Stated (two university and two community) will randomize 2850 obese women undergoing cesarean delivery to receive either prophylactic negative pressure wound therapy with the Prevena device or standard wound dressing. Women will be followed up to 30 days postoperatively to ascertain study outcomes. The primary outcome for the trial is superficial or deep SSI after cesarean according to the CDC's National Healthcare Safety Network definitions. The investigators will also assess other wound complications, adverse events potentially attributable to NPWT and cost-effectiveness as measured by incremental cost per case of SSI prevented and per quality-adjusted life year (QALY).
Interventions
DEVICEStandard Dressing
Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.
DEVICEProphylactic NPWT
The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
3M
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Gestational age ≥23weeks * BMI≥30 Pre-pregnancy or BMI at first prenatal visit * Planned or unplanned cesarean delivery
Exclusion criteria
* Non-availability for postoperative follow-up * Contraindication to NPWT applicable to women undergoing cesarean: Pre-existing infection around incision site, Bleeding disorder, Therapeutic anticoagulation, Irradiated skin, Allergy to any component of the dressing (e.g. silver, acrylic, silicone, adhesive tape)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Superficial or Deep Surgical Site Infections (SSIs) | 30 days postoperatively | As defined according to the Center for Disease Control and Prevention's (CDC) National Healthcare Safety Network criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications) | 30 days postoperatively | Frequency of wound hematoma, seroma, separation (other wound complications). Hematoma, seroma, separation (2cm or more). |
| Patient Pain Score | At discharge, an average of 4 days postoperatively | On a scale of 0 (least) - 10 (most). |
| Patient Satisfaction Score | At discharge, an average of 4 days postoperatively | On a scale of 0 (least) - 10 (most). |
| Number of Participants With Physician Office Visit, Emergency Room Visit, Attendance at Wound Clinic, Use Antibiotics, Hospital Readmission for Wound Related Problems (Measures of Healthcare Resource Utilization) | 30 days postoperatively | Frequency of physician office visit, emergency room visit, attendance at wound clinic, use antibiotics, hospital readmission for wound related problems (measures of healthcare resource utilization). |
| Number of Participants With Skin Blistering, Erythema, Wound Bleeding (Measures of Adverse Skin Events) | 30 days postoperatively | Frequency of skin blistering, erythema, wound bleeding (measures of adverse skin events). |
| Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs) | 30 days postoperatively | As defined according to the CDC's National Healthcare Safety Network criteria. |
| Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess) | 30 days postoperatively | As defined according to the CDC's National Healthcare Safety Network criteria. |
| Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More). | 30 days postoperatively | Frequency of a composite of any wound complication including SSI, hematoma, seroma, separation (2cm or more). SSI, hematoma, seroma, separation (2cm or more). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incremental Cost Per Quality-Adjusted Life-year | 30 days postoperatively | Based on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data. |
| Risk Factors for Surgical Site Infections in Obese Women | 30 days postoperatively | Based on combined cohort. Results of the risk factor analysis will be published separately from the effectiveness and safety data. |
| Types and Frequency of Different Bacteria Including Methicillin-resistant Staphylococcus Aureus | 30 days postoperatively | Types and frequency of different bacteria including methicillin-resistant Staphylococcus aureus. |
| Incremental Cost Per SSI Prevented | 30 days postoperatively | Based on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prophylactic NPWT Women assigned to prophylactic NPWT will have the Prevena device applied and secured with fixation adhesion strips. The device will be monitored while the patient is in the hospital to confirm that it is functioning well. The device will be removed prior to discharge, typically on postoperative day 4, but longer for up to 7 days for patients who remain hospitalized.
Prophylactic NPWT: The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure. | 806 |
| Standard Dressing Women assigned to standard care will receive routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing will be removed after 24 - 48 hours.
Standard Dressing: Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape. | 802 |
| Total | 1,608 |
Baseline characteristics
| Characteristic | Prophylactic NPWT | Standard Dressing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 5 Participants | 6 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 805 Participants | 797 Participants | 1602 Participants |
| Age, Continuous | 29.8 years STANDARD_DEVIATION 5.6 | 30.1 years STANDARD_DEVIATION 5.9 | 29.9 years STANDARD_DEVIATION 5.7 |
| BMI | 39.6 kg / m^2 STANDARD_DEVIATION 7.7 | 39.5 kg / m^2 STANDARD_DEVIATION 8.1 | 39.6 kg / m^2 STANDARD_DEVIATION 7.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 27 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 772 Participants | 775 Participants | 1547 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 453 Participants | 452 Participants | 905 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 | 22 Participants | 20 Participants | 42 Participants |
| Race (NIH/OMB) White | 331 Participants | 330 Participants | 661 Participants |
| Region of Enrollment United States | 806 Participants | 802 Participants | 1608 Participants |
| Sex: Female, Male Female | 806 Participants | 802 Participants | 1608 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 806 | 0 / 802 |
| other Total, other adverse events | 56 / 806 | 5 / 802 |
| serious Total, serious adverse events | 4 / 806 | 5 / 802 |
Outcome results
Primary
Number of Participants With Superficial or Deep Surgical Site Infections (SSIs)
As defined according to the Center for Disease Control and Prevention's (CDC) National Healthcare Safety Network criteria.
Time frame: 30 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prophylactic NPWT | Number of Participants With Superficial or Deep Surgical Site Infections (SSIs) | 29 Participants |
| Standard Dressing | Number of Participants With Superficial or Deep Surgical Site Infections (SSIs) | 27 Participants |
Secondary
Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More).
Frequency of a composite of any wound complication including SSI, hematoma, seroma, separation (2cm or more). SSI, hematoma, seroma, separation (2cm or more).
Time frame: 30 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prophylactic NPWT | Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More). | 52 Participants |
| Standard Dressing | Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More). | 54 Participants |
Secondary
Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess)
As defined according to the CDC's National Healthcare Safety Network criteria.
Time frame: 30 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prophylactic NPWT | Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess) | 2 Participants |
| Standard Dressing | Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess) | 2 Participants |
Secondary
Number of Participants With Physician Office Visit, Emergency Room Visit, Attendance at Wound Clinic, Use Antibiotics, Hospital Readmission for Wound Related Problems (Measures of Healthcare Resource Utilization)
Frequency of physician office visit, emergency room visit, attendance at wound clinic, use antibiotics, hospital readmission for wound related problems (measures of healthcare resource utilization).
Time frame: 30 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prophylactic NPWT | Number of Participants With Physician Office Visit, Emergency Room Visit, Attendance at Wound Clinic, Use Antibiotics, Hospital Readmission for Wound Related Problems (Measures of Healthcare Resource Utilization) | 130 Participants |
| Standard Dressing | Number of Participants With Physician Office Visit, Emergency Room Visit, Attendance at Wound Clinic, Use Antibiotics, Hospital Readmission for Wound Related Problems (Measures of Healthcare Resource Utilization) | 132 Participants |
Secondary
Number of Participants With Skin Blistering, Erythema, Wound Bleeding (Measures of Adverse Skin Events)
Frequency of skin blistering, erythema, wound bleeding (measures of adverse skin events).
Time frame: 30 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prophylactic NPWT | Number of Participants With Skin Blistering, Erythema, Wound Bleeding (Measures of Adverse Skin Events) | 46 Participants |
| Standard Dressing | Number of Participants With Skin Blistering, Erythema, Wound Bleeding (Measures of Adverse Skin Events) | 5 Participants |
Secondary
Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs)
As defined according to the CDC's National Healthcare Safety Network criteria.
Time frame: 30 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prophylactic NPWT | Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs) | 29 Participants |
| Standard Dressing | Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs) | 27 Participants |
Secondary
Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications)
Frequency of wound hematoma, seroma, separation (other wound complications). Hematoma, seroma, separation (2cm or more).
Time frame: 30 days postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prophylactic NPWT | Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications) | 21 Participants |
| Standard Dressing | Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications) | 25 Participants |
Secondary
Patient Pain Score
On a scale of 0 (least) - 10 (most).
Time frame: At discharge, an average of 4 days postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prophylactic NPWT | Patient Pain Score | 3 score on a scale |
| Standard Dressing | Patient Pain Score | 3 score on a scale |
Secondary
Patient Pain Score
On a scale of 0 (least) - 10 (most).
Time frame: At postoperative day 30
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prophylactic NPWT | Patient Pain Score | 0 score on a scale |
| Standard Dressing | Patient Pain Score | 0 score on a scale |
Secondary
Patient Satisfaction Score
On a scale of 0 (least) - 10 (most).
Time frame: At discharge, an average of 4 days postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prophylactic NPWT | Patient Satisfaction Score | 10 score on a scale |
| Standard Dressing | Patient Satisfaction Score | 9 score on a scale |
Secondary
Patient Satisfaction Score
On a scale of 0 (least) - 10 (most).
Time frame: At postoperative day 30
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prophylactic NPWT | Patient Satisfaction Score | 10 score on a scale |
| Standard Dressing | Patient Satisfaction Score | 10 score on a scale |
Other Pre-specified
Incremental Cost Per Quality-Adjusted Life-year
Based on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data.
Time frame: 30 days postoperatively
Other Pre-specified
Incremental Cost Per SSI Prevented
Based on economic analysis to be done along side trial. Results of the economic analysis will be published separately from the effectiveness and safety data.
Time frame: 30 days postoperatively
Other Pre-specified
Risk Factors for Surgical Site Infections in Obese Women
Based on combined cohort. Results of the risk factor analysis will be published separately from the effectiveness and safety data.
Time frame: 30 days postoperatively
Other Pre-specified
Types and Frequency of Different Bacteria Including Methicillin-resistant Staphylococcus Aureus
Types and frequency of different bacteria including methicillin-resistant Staphylococcus aureus.
Time frame: 30 days postoperatively