Trial Outcomes & Findings for The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions (NCT NCT01450631)
NCT ID: NCT01450631
Last Updated: 2024-10-16
Results Overview
Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include: * Unanticipated local inflammatory response * Prolonged drainage * Fluid collection * Dehiscence * Surgical site infection (SSI)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
Post-op Day 42 (+/- 10 days) after Cesarean section surgery
Results posted on
2024-10-16
Participant Flow
Subjects for the study were recruited from a hospital Labor and Delivery Unit. Recruitment period: 26JAN2012 (site initiation) - 17DEC2013 (LPO)
Participant milestones
| Measure |
Standard Dressing
Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.
Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy.
|
Prevena™ (PIMS)
PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.
Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
|
Overall Study
COMPLETED
|
43
|
42
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Standard Dressing
Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.
Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy.
|
Prevena™ (PIMS)
PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.
Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions
Baseline characteristics by cohort
| Measure |
Standard Dressing
n=46 Participants
Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.
Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy.
|
Prevena™ (PIMS)
n=46 Participants
PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.
Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.67 years
STANDARD_DEVIATION 4.953 • n=5 Participants
|
30.35 years
STANDARD_DEVIATION 5.724 • n=7 Participants
|
30.01 years
STANDARD_DEVIATION 5.334 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
35 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
27 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
87 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
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
46 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
BMI (kg/m2)
|
46.79 kg/m2
STANDARD_DEVIATION 5.608 • n=5 Participants
|
46.25 kg/m2
STANDARD_DEVIATION 7.319 • n=7 Participants
|
46.52 kg/m2
STANDARD_DEVIATION 6.489 • n=5 Participants
|
|
Gestational Age (weeks)
|
37.87 weeks
STANDARD_DEVIATION 1.976 • n=5 Participants
|
38.08 weeks
STANDARD_DEVIATION 1.983 • n=7 Participants
|
37.97 weeks
STANDARD_DEVIATION 1.972 • n=5 Participants
|
PRIMARY outcome
Timeframe: Post-op Day 42 (+/- 10 days) after Cesarean section surgeryPopulation: The Per-protocol Population was used for primary and secondary endpoint analysis.
Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include: * Unanticipated local inflammatory response * Prolonged drainage * Fluid collection * Dehiscence * Surgical site infection (SSI)
Outcome measures
| Measure |
Standard Dressing
n=43 Participants
Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.
Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy.
|
Prevena™ (PIMS)
n=39 Participants
PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.
Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister.
|
|---|---|---|
|
Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.
|
7 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Post-op Day: 42 (+/- 10 days) after Cesarean section surgeryPopulation: The Per-protocol Population was used for primary and secondary endpoint analysis.
Incidence rate of surgical incision intervention (SII) post Cesarean section surgery. Interventions include: * Antimicrobials for surgical site infection * Surgical drainage of the incision * Surgical incision packing * Adjunctive negative pressure therapy * Debridement * Re-operation
Outcome measures
| Measure |
Standard Dressing
n=43 Participants
Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.
Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy.
|
Prevena™ (PIMS)
n=39 Participants
PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.
Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister.
|
|---|---|---|
|
Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.
|
6 participants
|
1 participants
|
Adverse Events
Standard Dressing
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Prevena™ (PIMS)
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Dressing
n=46 participants at risk
Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.
Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy.
|
Prevena™ (PIMS)
n=46 participants at risk
PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.
Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister.
|
|---|---|---|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Gastrointestinal disorders
Gastric Ulcer Perforation
|
0.00%
0/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Infections and infestations
Endometritis
|
2.2%
1/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Injury, poisoning and procedural complications
Seroma
|
2.2%
1/46 • 1 year 10 months
|
0.00%
0/46 • 1 year 10 months
|
Other adverse events
| Measure |
Standard Dressing
n=46 participants at risk
Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.
Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy.
|
Prevena™ (PIMS)
n=46 participants at risk
PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.
Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Gastrointestinal disorders
Constipation
|
2.2%
1/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Infections and infestations
Abscess
|
2.2%
1/46 • 1 year 10 months
|
0.00%
0/46 • 1 year 10 months
|
|
Infections and infestations
Celluitis
|
2.2%
1/46 • 1 year 10 months
|
0.00%
0/46 • 1 year 10 months
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Infections and infestations
Gastroenteritis Viral
|
2.2%
1/46 • 1 year 10 months
|
0.00%
0/46 • 1 year 10 months
|
|
Infections and infestations
Intertrigo Candida
|
0.00%
0/46 • 1 year 10 months
|
4.3%
2/46 • 1 year 10 months
|
|
Infections and infestations
Mastitis
|
0.00%
0/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Infections and infestations
Postoperative Infection
|
6.5%
3/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Injury, poisoning and procedural complications
Blister
|
0.00%
0/46 • 1 year 10 months
|
6.5%
3/46 • 1 year 10 months
|
|
Injury, poisoning and procedural complications
Seroma
|
4.3%
2/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
10.9%
5/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Renal and urinary disorders
Dysuria
|
2.2%
1/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Renal and urinary disorders
Pollakiuria
|
2.2%
1/46 • 1 year 10 months
|
0.00%
0/46 • 1 year 10 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.2%
1/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Skin and subcutaneous tissue disorders
Puritus
|
0.00%
0/46 • 1 year 10 months
|
2.2%
1/46 • 1 year 10 months
|
|
Vascular disorders
Haematoma
|
2.2%
1/46 • 1 year 10 months
|
0.00%
0/46 • 1 year 10 months
|
|
Vascular disorders
Hypertension
|
6.5%
3/46 • 1 year 10 months
|
6.5%
3/46 • 1 year 10 months
|
Additional Information
Jill Twardowski, Director of Clinical Operations
KCI USA, Inc.
Phone: 210-515-4166
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60