Trial Outcomes & Findings for Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial (NCT NCT03009110)

Results Overview

As defined according to the Center for Disease Control and Prevention's (CDC) National Healthcare Safety Network criteria.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1624 participants

Primary outcome timeframe

30 days postoperatively

Results posted on

2023-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	816	808
Overall Study COMPLETED	806	802
Overall Study NOT COMPLETED	10	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preventing Adverse Incisional Outcomes at Cesarean Multicenter Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prophylactic NPWT n=806 Participants 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.	Standard Dressing n=802 Participants 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.	Total n=1608 Participants Total of all reporting groups
Age, Categorical Between 18 and 65 years	805 Participants n=5 Participants	797 Participants n=7 Participants	1602 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.8 years STANDARD_DEVIATION 5.6 • n=5 Participants	30.1 years STANDARD_DEVIATION 5.9 • n=7 Participants	29.9 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	806 Participants n=5 Participants	802 Participants n=7 Participants	1608 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	34 Participants n=5 Participants	27 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	772 Participants n=5 Participants	775 Participants n=7 Participants	1547 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	453 Participants n=5 Participants	452 Participants n=7 Participants	905 Participants n=5 Participants
Race (NIH/OMB) White	331 Participants n=5 Participants	330 Participants n=7 Participants	661 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment United States	806 Participants n=5 Participants	802 Participants n=7 Participants	1608 Participants n=5 Participants
BMI	39.6 kg / m^2 STANDARD_DEVIATION 7.7 • n=5 Participants	39.5 kg / m^2 STANDARD_DEVIATION 8.1 • n=7 Participants	39.6 kg / m^2 STANDARD_DEVIATION 7.9 • n=5 Participants
Age, Categorical <=18 years	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days postoperatively

As defined according to the Center for Disease Control and Prevention's (CDC) National Healthcare Safety Network criteria.

Outcome measures

Outcome measures
Measure	Prophylactic NPWT n=806 Participants 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.	Standard Dressing n=802 Participants 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.
Number of Participants With Superficial or Deep Surgical Site Infections (SSIs)	29 Participants	27 Participants

SECONDARY outcome

Timeframe: 30 days postoperatively

As defined according to the CDC's National Healthcare Safety Network criteria.

Outcome measures

Outcome measures
Measure	Prophylactic NPWT n=806 Participants 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.	Standard Dressing n=802 Participants 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.
Number of Participants With Superficial, Deep or Organ Space SSIs (Individual Types of SSIs)	29 Participants	27 Participants

SECONDARY outcome

Timeframe: 30 days postoperatively

As defined according to the CDC's National Healthcare Safety Network criteria.

Outcome measures

Outcome measures
Measure	Prophylactic NPWT n=806 Participants 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.	Standard Dressing n=802 Participants 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.
Number of Participants With Organ Space SSIs (Endometritis, Intraabdominal Abscess)	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days postoperatively

Frequency of wound hematoma, seroma, separation (other wound complications). Hematoma, seroma, separation (2cm or more).

Outcome measures

Outcome measures
Measure	Prophylactic NPWT n=806 Participants 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.	Standard Dressing n=802 Participants 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.
Number of Participants With Wound Hematoma, Seroma, Separation (Other Wound Complications)	21 Participants	25 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Prophylactic NPWT n=806 Participants 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.	Standard Dressing n=802 Participants 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.
Number of Participants With a Composite of Any Wound Complication Including SSI, Hematoma, Seroma, Separation (2cm or More).	52 Participants	54 Participants

SECONDARY outcome

Timeframe: At discharge, an average of 4 days postoperatively

On a scale of 0 (least) - 10 (most).

Outcome measures

Outcome measures
Measure	Prophylactic NPWT n=806 Participants 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.	Standard Dressing n=802 Participants 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.
Patient Pain Score	3 score on a scale Interval 0.0 to 5.0	3 score on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: At postoperative day 30

On a scale of 0 (least) - 10 (most).

Outcome measures

Outcome measures
Measure	Prophylactic NPWT n=806 Participants 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.	Standard Dressing n=802 Participants 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.
Patient Pain Score	0 score on a scale Interval 0.0 to 2.0	0 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: At discharge, an average of 4 days postoperatively

On a scale of 0 (least) - 10 (most).

Outcome measures

Outcome measures
Measure	Prophylactic NPWT n=806 Participants 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.	Standard Dressing n=802 Participants 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.
Patient Satisfaction Score	10 score on a scale Interval 8.0 to 10.0	9 score on a scale Interval 7.0 to 10.0

SECONDARY outcome

Timeframe: At postoperative day 30

On a scale of 0 (least) - 10 (most).

Outcome measures

Outcome measures
Measure	Prophylactic NPWT n=806 Participants 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.	Standard Dressing n=802 Participants 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.
Patient Satisfaction Score	10 score on a scale Interval 9.0 to 10.0	10 score on a scale Interval 8.0 to 10.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Prophylactic NPWT n=806 Participants 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.	Standard Dressing n=802 Participants 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.
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	132 Participants

SECONDARY outcome

Timeframe: 30 days postoperatively

Frequency of skin blistering, erythema, wound bleeding (measures of adverse skin events).

Outcome measures

Outcome measures
Measure	Prophylactic NPWT n=806 Participants 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.	Standard Dressing n=802 Participants 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.
Number of Participants With Skin Blistering, Erythema, Wound Bleeding (Measures of Adverse Skin Events)	46 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days postoperatively

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Prophylactic NPWT n=806 participants at risk 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.	Standard Dressing n=802 participants at risk 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.
Skin and subcutaneous tissue disorders Maternal ICU admission	0.12% 1/806 • Number of events 1 • 30 days Occurring within data collection period, to be reported within 24 hours of learning of the event: Serious Adverse Events - Death or Life-threatening situations: Postpartum hysterectomy for infection control Maternal sepsis Necrotizing fasciitis Maternal ICU admission Abnormal findings in labs or assessments will not be reported as adverse events. Adverse Events of special interest will be reported - mild/moderate reactions: Skin blisters Wound bleeding Allergic skin reaction	0.25% 2/802 • Number of events 2 • 30 days Occurring within data collection period, to be reported within 24 hours of learning of the event: Serious Adverse Events - Death or Life-threatening situations: Postpartum hysterectomy for infection control Maternal sepsis Necrotizing fasciitis Maternal ICU admission Abnormal findings in labs or assessments will not be reported as adverse events. Adverse Events of special interest will be reported - mild/moderate reactions: Skin blisters Wound bleeding Allergic skin reaction
Blood and lymphatic system disorders Maternal Sepsis	0.37% 3/806 • Number of events 3 • 30 days Occurring within data collection period, to be reported within 24 hours of learning of the event: Serious Adverse Events - Death or Life-threatening situations: Postpartum hysterectomy for infection control Maternal sepsis Necrotizing fasciitis Maternal ICU admission Abnormal findings in labs or assessments will not be reported as adverse events. Adverse Events of special interest will be reported - mild/moderate reactions: Skin blisters Wound bleeding Allergic skin reaction	0.25% 2/802 • Number of events 2 • 30 days Occurring within data collection period, to be reported within 24 hours of learning of the event: Serious Adverse Events - Death or Life-threatening situations: Postpartum hysterectomy for infection control Maternal sepsis Necrotizing fasciitis Maternal ICU admission Abnormal findings in labs or assessments will not be reported as adverse events. Adverse Events of special interest will be reported - mild/moderate reactions: Skin blisters Wound bleeding Allergic skin reaction
Reproductive system and breast disorders Postpartum hysterectomy	0.12% 1/806 • Number of events 1 • 30 days Occurring within data collection period, to be reported within 24 hours of learning of the event: Serious Adverse Events - Death or Life-threatening situations: Postpartum hysterectomy for infection control Maternal sepsis Necrotizing fasciitis Maternal ICU admission Abnormal findings in labs or assessments will not be reported as adverse events. Adverse Events of special interest will be reported - mild/moderate reactions: Skin blisters Wound bleeding Allergic skin reaction	0.12% 1/802 • Number of events 1 • 30 days Occurring within data collection period, to be reported within 24 hours of learning of the event: Serious Adverse Events - Death or Life-threatening situations: Postpartum hysterectomy for infection control Maternal sepsis Necrotizing fasciitis Maternal ICU admission Abnormal findings in labs or assessments will not be reported as adverse events. Adverse Events of special interest will be reported - mild/moderate reactions: Skin blisters Wound bleeding Allergic skin reaction

Other adverse events

Other adverse events
Measure	Prophylactic NPWT n=806 participants at risk 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.	Standard Dressing n=802 participants at risk 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.
Skin and subcutaneous tissue disorders Blisters	3.3% 27/806 • Number of events 27 • 30 days Occurring within data collection period, to be reported within 24 hours of learning of the event: Serious Adverse Events - Death or Life-threatening situations: Postpartum hysterectomy for infection control Maternal sepsis Necrotizing fasciitis Maternal ICU admission Abnormal findings in labs or assessments will not be reported as adverse events. Adverse Events of special interest will be reported - mild/moderate reactions: Skin blisters Wound bleeding Allergic skin reaction	0.25% 2/802 • Number of events 2 • 30 days Occurring within data collection period, to be reported within 24 hours of learning of the event: Serious Adverse Events - Death or Life-threatening situations: Postpartum hysterectomy for infection control Maternal sepsis Necrotizing fasciitis Maternal ICU admission Abnormal findings in labs or assessments will not be reported as adverse events. Adverse Events of special interest will be reported - mild/moderate reactions: Skin blisters Wound bleeding Allergic skin reaction
Blood and lymphatic system disorders Bleeding	1.1% 9/806 • Number of events 9 • 30 days Occurring within data collection period, to be reported within 24 hours of learning of the event: Serious Adverse Events - Death or Life-threatening situations: Postpartum hysterectomy for infection control Maternal sepsis Necrotizing fasciitis Maternal ICU admission Abnormal findings in labs or assessments will not be reported as adverse events. Adverse Events of special interest will be reported - mild/moderate reactions: Skin blisters Wound bleeding Allergic skin reaction	0.00% 0/802 • 30 days Occurring within data collection period, to be reported within 24 hours of learning of the event: Serious Adverse Events - Death or Life-threatening situations: Postpartum hysterectomy for infection control Maternal sepsis Necrotizing fasciitis Maternal ICU admission Abnormal findings in labs or assessments will not be reported as adverse events. Adverse Events of special interest will be reported - mild/moderate reactions: Skin blisters Wound bleeding Allergic skin reaction
Skin and subcutaneous tissue disorders Erythema	1.2% 10/806 • Number of events 10 • 30 days Occurring within data collection period, to be reported within 24 hours of learning of the event: Serious Adverse Events - Death or Life-threatening situations: Postpartum hysterectomy for infection control Maternal sepsis Necrotizing fasciitis Maternal ICU admission Abnormal findings in labs or assessments will not be reported as adverse events. Adverse Events of special interest will be reported - mild/moderate reactions: Skin blisters Wound bleeding Allergic skin reaction	0.37% 3/802 • Number of events 3 • 30 days Occurring within data collection period, to be reported within 24 hours of learning of the event: Serious Adverse Events - Death or Life-threatening situations: Postpartum hysterectomy for infection control Maternal sepsis Necrotizing fasciitis Maternal ICU admission Abnormal findings in labs or assessments will not be reported as adverse events. Adverse Events of special interest will be reported - mild/moderate reactions: Skin blisters Wound bleeding Allergic skin reaction
Skin and subcutaneous tissue disorders Rash	1.7% 14/806 • Number of events 14 • 30 days Occurring within data collection period, to be reported within 24 hours of learning of the event: Serious Adverse Events - Death or Life-threatening situations: Postpartum hysterectomy for infection control Maternal sepsis Necrotizing fasciitis Maternal ICU admission Abnormal findings in labs or assessments will not be reported as adverse events. Adverse Events of special interest will be reported - mild/moderate reactions: Skin blisters Wound bleeding Allergic skin reaction	0.12% 1/802 • Number of events 1 • 30 days Occurring within data collection period, to be reported within 24 hours of learning of the event: Serious Adverse Events - Death or Life-threatening situations: Postpartum hysterectomy for infection control Maternal sepsis Necrotizing fasciitis Maternal ICU admission Abnormal findings in labs or assessments will not be reported as adverse events. Adverse Events of special interest will be reported - mild/moderate reactions: Skin blisters Wound bleeding Allergic skin reaction

Additional Information

Graham Hogg

Indiana University School of Medicine

Phone: 317-962-0415

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place