Trial Outcomes & Findings for Prophylactic Incisional Care in Obese Women at Cesarean (NCT NCT02578745)
NCT ID: NCT02578745
Last Updated: 2019-11-27
Results Overview
Superficial or deep SSIs or other wound complications (separation, hematoma, seroma) after cesarean. SSI will be defined according to the Centers for Disease Control (CDC) criteria as infections at the surgical site occurring within 30 days of cesarean delivery, and classified as superficial, deep, or organ/space occupying.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
30 days
Results posted on
2019-11-27
Participant Flow
We recruited 120 patients from October 2015 to April 2016 at Washington University Medical Center
We enrolled patients undergoing scheduled or emergency cesarean delivery.
Participant milestones
| Measure |
Prophylactic NPWT
Women assigned to prophylactic NPWT had the PICO device applied and secured with fixation adhesion strips. The device was monitored while the patient was in the hospital to confirm that it wass functioning well. The device will be removed prior to discharge, typically on postoperative day 4.
Prophylactic NPWT (PICO system): The PICO NPWT system is a small, lightweight (\~126 grams), portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary super-absorbent adhesive dressing. It is supplied as a pump with two sterile dressing kits and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 10 to 40 cm. The PICO pump maintains negative pressure of -80 mmHg (+/-20 mmHg) to the wound surface.
|
Standard Dressing
Women assigned to standard care had routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing was removed after 24 - 48 hours.
Standard Dressing: Standard wound dressing consists of routine postoperative wound dressing consisting of layers of gauze and adhesive tape.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prophylactic Incisional Care in Obese Women at Cesarean
Baseline characteristics by cohort
| Measure |
Prophylactic NPWT
n=60 Participants
Women assigned to prophylactic NPWT had the PICO device applied and secured with fixation adhesion strips. The device was monitored while the patient is in the hospital to confirm that it is functioning well. The device was removed prior to discharge, typically on postoperative day 4.
Prophylactic NPWT (PICO system): The PICO NPWT system is a small, lightweight (\~126 grams), portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary super-absorbent adhesive dressing. It is supplied as a pump with two sterile dressing kits and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 10 to 40 cm. The PICO pump maintains negative pressure of -80 mmHg (+/-20 mmHg) to the wound surface.
|
Standard Dressing
n=60 Participants
Women assigned to standard care had routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing was removed after 24 - 48 hours.
Standard Dressing: Standard wound dressing consists of routine postoperative wound dressing consisting of layers of gauze and adhesive tape.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.3 years
STANDARD_DEVIATION 6.6 • n=99 Participants
|
28.7 years
STANDARD_DEVIATION 5.0 • n=107 Participants
|
29.0 years
STANDARD_DEVIATION 5.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=99 Participants
|
60 participants
n=107 Participants
|
120 participants
n=206 Participants
|
|
Body mass index
|
39.2 kg/m2
STANDARD_DEVIATION 9.2 • n=99 Participants
|
40.7 kg/m2
STANDARD_DEVIATION 8.6 • n=107 Participants
|
39.9 kg/m2
STANDARD_DEVIATION 8.9 • n=206 Participants
|
|
Scheduled cesarean
|
56 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 daysSuperficial or deep SSIs or other wound complications (separation, hematoma, seroma) after cesarean. SSI will be defined according to the Centers for Disease Control (CDC) criteria as infections at the surgical site occurring within 30 days of cesarean delivery, and classified as superficial, deep, or organ/space occupying.
Outcome measures
| Measure |
Prophylactic Negative Pressure Wound Therapy (NPWT)
n=60 Participants
Women assigned to prophylactic NPWT had the PICO device applied and secured with fixation adhesion strips. The device was monitored while the patient is in the hospital to confirm that it is functioning well. The device was removed prior to discharge, typically on postoperative day 4.
Prophylactic NPWT (PICO system): The PICO NPWT system is a small, lightweight (\~126 grams), portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary super-absorbent adhesive dressing. It is supplied as a pump with two sterile dressing kits and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 10 to 40 cm. The PICO pump maintains negative pressure of -80 mmHg (+/-20 mmHg) to the wound surface.
|
Standard Dressing
n=60 Participants
Women assigned to standard care had routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing was removed after 24 - 48 hours.
Standard Dressing: Standard wound dressing consists of routine postoperative wound dressing consisting of layers of gauze and adhesive tape.
|
|---|---|---|
|
Number of Participants With Composite Surgical Site Infection (SSI) or Other Wound Complication.
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 daysProportion of Participants with Surgical site infection; Proportion of Participants with wound separation; Proportion of participants with hematoma; Proportion of participants with seroma.
Outcome measures
| Measure |
Prophylactic Negative Pressure Wound Therapy (NPWT)
n=60 Participants
Women assigned to prophylactic NPWT had the PICO device applied and secured with fixation adhesion strips. The device was monitored while the patient is in the hospital to confirm that it is functioning well. The device was removed prior to discharge, typically on postoperative day 4.
Prophylactic NPWT (PICO system): The PICO NPWT system is a small, lightweight (\~126 grams), portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary super-absorbent adhesive dressing. It is supplied as a pump with two sterile dressing kits and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 10 to 40 cm. The PICO pump maintains negative pressure of -80 mmHg (+/-20 mmHg) to the wound surface.
|
Standard Dressing
n=60 Participants
Women assigned to standard care had routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing was removed after 24 - 48 hours.
Standard Dressing: Standard wound dressing consists of routine postoperative wound dressing consisting of layers of gauze and adhesive tape.
|
|---|---|---|
|
Number of Participants With Any COMPONENT of SSI or Composite Wound Complication
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Postoperative days 2Participant pain scores on postoperative day 2 on a 0 (minimum) to 10 (maximum) 0n Likert Scale, where 0 is no pain and 10 is the worse pain. Higher score means worse outcome
Outcome measures
| Measure |
Prophylactic Negative Pressure Wound Therapy (NPWT)
n=60 Participants
Women assigned to prophylactic NPWT had the PICO device applied and secured with fixation adhesion strips. The device was monitored while the patient is in the hospital to confirm that it is functioning well. The device was removed prior to discharge, typically on postoperative day 4.
Prophylactic NPWT (PICO system): The PICO NPWT system is a small, lightweight (\~126 grams), portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary super-absorbent adhesive dressing. It is supplied as a pump with two sterile dressing kits and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 10 to 40 cm. The PICO pump maintains negative pressure of -80 mmHg (+/-20 mmHg) to the wound surface.
|
Standard Dressing
n=60 Participants
Women assigned to standard care had routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing was removed after 24 - 48 hours.
Standard Dressing: Standard wound dressing consists of routine postoperative wound dressing consisting of layers of gauze and adhesive tape.
|
|---|---|---|
|
Pain Score on a 0 to 10 on Likert Scale
|
0 units on a scale
Interval 0.0 to 1.0
|
1 units on a scale
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: 30 daysRate of positive wound culture in participants with SSI after cesarean.
Outcome measures
| Measure |
Prophylactic Negative Pressure Wound Therapy (NPWT)
n=60 Participants
Women assigned to prophylactic NPWT had the PICO device applied and secured with fixation adhesion strips. The device was monitored while the patient is in the hospital to confirm that it is functioning well. The device was removed prior to discharge, typically on postoperative day 4.
Prophylactic NPWT (PICO system): The PICO NPWT system is a small, lightweight (\~126 grams), portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary super-absorbent adhesive dressing. It is supplied as a pump with two sterile dressing kits and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 10 to 40 cm. The PICO pump maintains negative pressure of -80 mmHg (+/-20 mmHg) to the wound surface.
|
Standard Dressing
n=60 Participants
Women assigned to standard care had routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing was removed after 24 - 48 hours.
Standard Dressing: Standard wound dressing consists of routine postoperative wound dressing consisting of layers of gauze and adhesive tape.
|
|---|---|---|
|
Number of Participants With Positive Wound Culture
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysRate of methicillin-resistant Staphylococcus aureus in patients with SSI after cesarean.
Outcome measures
| Measure |
Prophylactic Negative Pressure Wound Therapy (NPWT)
n=60 Participants
Women assigned to prophylactic NPWT had the PICO device applied and secured with fixation adhesion strips. The device was monitored while the patient is in the hospital to confirm that it is functioning well. The device was removed prior to discharge, typically on postoperative day 4.
Prophylactic NPWT (PICO system): The PICO NPWT system is a small, lightweight (\~126 grams), portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary super-absorbent adhesive dressing. It is supplied as a pump with two sterile dressing kits and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 10 to 40 cm. The PICO pump maintains negative pressure of -80 mmHg (+/-20 mmHg) to the wound surface.
|
Standard Dressing
n=60 Participants
Women assigned to standard care had routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing was removed after 24 - 48 hours.
Standard Dressing: Standard wound dressing consists of routine postoperative wound dressing consisting of layers of gauze and adhesive tape.
|
|---|---|---|
|
Number of Participants With Methicillin-resistant Staphylococcus Aureus.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysRate of composite of adverse events potentially attributable to NPWT including skin blisters, erythema, wound bleeding.
Outcome measures
| Measure |
Prophylactic Negative Pressure Wound Therapy (NPWT)
n=60 Participants
Women assigned to prophylactic NPWT had the PICO device applied and secured with fixation adhesion strips. The device was monitored while the patient is in the hospital to confirm that it is functioning well. The device was removed prior to discharge, typically on postoperative day 4.
Prophylactic NPWT (PICO system): The PICO NPWT system is a small, lightweight (\~126 grams), portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary super-absorbent adhesive dressing. It is supplied as a pump with two sterile dressing kits and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 10 to 40 cm. The PICO pump maintains negative pressure of -80 mmHg (+/-20 mmHg) to the wound surface.
|
Standard Dressing
n=60 Participants
Women assigned to standard care had routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing was removed after 24 - 48 hours.
Standard Dressing: Standard wound dressing consists of routine postoperative wound dressing consisting of layers of gauze and adhesive tape.
|
|---|---|---|
|
Number of Participants With Any Prophylactic Negative Pressure-related Adverse Events.
|
2 Participants
|
0 Participants
|
Adverse Events
Prophylactic NPWT
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Standard Dressing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prophylactic NPWT
n=60 participants at risk
Women assigned to prophylactic NPWT had the PICO device applied and secured with fixation adhesion strips. The device was monitored while the patient was in the hospital to confirm that it wass functioning well. The device will be removed prior to discharge, typically on postoperative day 4.
Prophylactic NPWT (PICO system): The PICO NPWT system is a small, lightweight (\~126 grams), portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary super-absorbent adhesive dressing. It is supplied as a pump with two sterile dressing kits and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 10 to 40 cm. The PICO pump maintains negative pressure of -80 mmHg (+/-20 mmHg) to the wound surface.
|
Standard Dressing
n=60 participants at risk
Women assigned to standard care had routine postoperative wound dressing consisting of layers of gauze and adhesive tap. The dressing was removed after 24 - 48 hours.
Standard Dressing: Standard wound dressing consists of routine postoperative wound dressing consisting of layers of gauze and adhesive tape.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruiritus
|
3.3%
2/60 • Number of events 2 • 30 days
|
0.00%
0/60 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place