Trial Outcomes & Findings for Negative Pressure Wound Therapy in Cesarean Section (NCT NCT02289157)
NCT ID: NCT02289157
Last Updated: 2018-07-02
Results Overview
Number of Patients with Wound infection complications: hematoma, seroma, dehiscence, or Surgical Site Infection.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
441 participants
Primary outcome timeframe
Day of surgery to 30 days postoperative
Results posted on
2018-07-02
Participant Flow
Patients recruited in the Parkland Hospital Maternal-Fetal Medicine High Risk Clinic, on the Antepartum Floor, in Labor and Delivery, and in the preoperative holding area. January 2015 until July 2016. 850 screened. See Figure 1 Flow Diagram.
Patients were excluded for pre-specified exclusion criteria and if they delivered vaginally after consent was obtained. 850 patients were screened. 173 declined participation, 5 withdrew consent, 2 delivered at outside facility, 211 delivered vaginally, 10 did not meet inclusion criteria, and 8 not identified to be enrolled.
Participant milestones
| Measure |
Negative Pressure Wound Therapy
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
|
Standard Dressing
After standard cesarean section completed patients will have standard dressing placed.
|
|---|---|---|
|
Overall Study
STARTED
|
222
|
219
|
|
Overall Study
No Post op Check or Follow up Phone Call
|
2
|
4
|
|
Overall Study
COMPLETED
|
222
|
219
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Negative Pressure Wound Therapy in Cesarean Section
Baseline characteristics by cohort
| Measure |
Negative Pressure Wound Therapy
n=222 Participants
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
|
Standard Dressing
n=219 Participants
After standard cesarean section completed patients will have standard dressing placed.
|
Total
n=441 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.1 years
STANDARD_DEVIATION 6.1 • n=99 Participants
|
30.3 years
STANDARD_DEVIATION 6.1 • n=107 Participants
|
29.7 years
STANDARD_DEVIATION 6.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
222 Participants
n=99 Participants
|
219 Participants
n=107 Participants
|
441 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race Black
|
56 participants
n=99 Participants
|
60 participants
n=107 Participants
|
116 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race Hispanic
|
151 participants
n=99 Participants
|
146 participants
n=107 Participants
|
297 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race White
|
15 participants
n=99 Participants
|
13 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Gestational age at delivery
|
38.6 weeks
STANDARD_DEVIATION 1.9 • n=99 Participants
|
38.7 weeks
STANDARD_DEVIATION 4.5 • n=107 Participants
|
38.6 weeks
STANDARD_DEVIATION 3.5 • n=206 Participants
|
|
Parity
Parity 0
|
55 participants
n=99 Participants
|
42 participants
n=107 Participants
|
97 participants
n=206 Participants
|
|
Parity
Parity 1
|
64 participants
n=99 Participants
|
68 participants
n=107 Participants
|
132 participants
n=206 Participants
|
|
Parity
Parity 2
|
62 participants
n=99 Participants
|
57 participants
n=107 Participants
|
119 participants
n=206 Participants
|
|
Parity
Parity > 2
|
41 participants
n=99 Participants
|
52 participants
n=107 Participants
|
93 participants
n=206 Participants
|
|
BMI at Delivery
|
46.6 BMI = kg/meter^2
STANDARD_DEVIATION 6.0 • n=99 Participants
|
45.8 BMI = kg/meter^2
STANDARD_DEVIATION 5.8 • n=107 Participants
|
46.3 BMI = kg/meter^2
STANDARD_DEVIATION 6.2 • n=206 Participants
|
|
Tobacco use
|
18 participants
n=99 Participants
|
15 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Chronic hypertension
|
40 participants
n=99 Participants
|
36 participants
n=107 Participants
|
76 participants
n=206 Participants
|
|
Insulin Requiring Diabetes
|
36 participants
n=99 Participants
|
24 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Primary Cesarean
|
95 participants
n=99 Participants
|
80 participants
n=107 Participants
|
175 participants
n=206 Participants
|
|
Cesarean Priority
Scheduled
|
72 participants
n=99 Participants
|
72 participants
n=107 Participants
|
144 participants
n=206 Participants
|
|
Cesarean Priority
ASAP
|
141 participants
n=99 Participants
|
138 participants
n=107 Participants
|
279 participants
n=206 Participants
|
|
Cesarean Priority
Emergent
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Length of Surgery
|
84 minutes
n=99 Participants
|
80 minutes
n=107 Participants
|
82 minutes
n=206 Participants
|
|
Estimated blood loss
|
1181 ml
STANDARD_DEVIATION 294 • n=99 Participants
|
1136 ml
STANDARD_DEVIATION 285 • n=107 Participants
|
1159 ml
STANDARD_DEVIATION 291 • n=206 Participants
|
|
Midline skin incision
|
170 participants
n=99 Participants
|
158 participants
n=107 Participants
|
328 participants
n=206 Participants
|
|
Suture skin closure
|
210 Participants
n=99 Participants
|
211 Participants
n=107 Participants
|
421 Participants
n=206 Participants
|
|
Subcutaneous skin depth in cm
|
5.5 cm
STANDARD_DEVIATION 1.3 • n=99 Participants
|
5.3 cm
STANDARD_DEVIATION 1.8 • n=107 Participants
|
5.4 cm
STANDARD_DEVIATION 1.7 • n=206 Participants
|
|
Number subcutaneous layers closed
|
3 layers
n=99 Participants
|
3 layers
n=107 Participants
|
3 layers
n=206 Participants
|
|
Incision length in cm
|
14.5 cm
STANDARD_DEVIATION 2.5 • n=99 Participants
|
14.6 cm
STANDARD_DEVIATION 2.9 • n=107 Participants
|
14.6 cm
STANDARD_DEVIATION 2.7 • n=206 Participants
|
|
Patients in labor prior cesarean
|
44 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Induction Labor
|
47 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Ruptured Membranes
|
77 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Chorioamnionitis
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day of surgery to 30 days postoperativeNumber of Patients with Wound infection complications: hematoma, seroma, dehiscence, or Surgical Site Infection.
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=222 Participants
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
|
Standard Dressing
n=219 Participants
After standard cesarean section completed patients will have standard dressing placed.
|
|---|---|---|
|
Number of Participants With Wound Complication
|
37 Participants
|
42 Participants
|
PRIMARY outcome
Timeframe: Day of Surgery to 30 days postoperativeListing of different types of wound morbidity in the 2 cohorts: dehiscence, cellulitis, superficial SSI, deep SSI, organ space SSI
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=222 Participants
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
|
Standard Dressing
n=219 Participants
After standard cesarean section completed patients will have standard dressing placed.
|
|---|---|---|
|
Number of Participants With Classification of Wound Morbidity
Dehiscence
|
4 Participants
|
1 Participants
|
|
Number of Participants With Classification of Wound Morbidity
Cellulitis
|
12 Participants
|
16 Participants
|
|
Number of Participants With Classification of Wound Morbidity
Superficial incisional SSI
|
20 Participants
|
25 Participants
|
|
Number of Participants With Classification of Wound Morbidity
Deep incisional SSI
|
0 Participants
|
0 Participants
|
|
Number of Participants With Classification of Wound Morbidity
Organ space infection
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Length of Postoperative StayNumber of Days in Hospital after Initial Surgery
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=222 Participants
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
|
Standard Dressing
n=219 Participants
After standard cesarean section completed patients will have standard dressing placed.
|
|---|---|---|
|
Length of Postoperative Stay
|
3 days
Interval 3.0 to 4.0
|
3 days
Interval 3.0 to 4.0
|
SECONDARY outcome
Timeframe: After dismissal and readmitted within 30 days for wound morbidityNumber of days in hospital after readmission for wound morbidity
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=222 Participants
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
|
Standard Dressing
n=219 Participants
After standard cesarean section completed patients will have standard dressing placed.
|
|---|---|---|
|
Length of Stay After Readmission
|
16 days
Interval 6.0 to 22.0
|
21 days
Interval 11.0 to 25.0
|
SECONDARY outcome
Timeframe: Day of surgery to 30 days postoperativeNumber of emergency room visits made after initial discharge by the study (icNPT) and comparison groups.
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=222 Participants
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
|
Standard Dressing
n=219 Participants
After standard cesarean section completed patients will have standard dressing placed.
|
|---|---|---|
|
Number of Patients With Emergency Room Visits After Discharge
No ER visits
|
190 Participants
|
190 Participants
|
|
Number of Patients With Emergency Room Visits After Discharge
1 ER visit
|
30 Participants
|
28 Participants
|
|
Number of Patients With Emergency Room Visits After Discharge
2 ER visits
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day of surgery to 30 days postoperativeNumber of clinic visits made by patients after surgery concerning wound morbidity per patient
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=222 Participants
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
|
Standard Dressing
n=219 Participants
After standard cesarean section completed patients will have standard dressing placed.
|
|---|---|---|
|
Number of Patients With Number of Clinic Visits
1 visit
|
15 participants
|
15 participants
|
|
Number of Patients With Number of Clinic Visits
2 visits
|
4 participants
|
6 participants
|
|
Number of Patients With Number of Clinic Visits
3 visits
|
5 participants
|
2 participants
|
|
Number of Patients With Number of Clinic Visits
4 visits
|
1 participants
|
4 participants
|
|
Number of Patients With Number of Clinic Visits
5 visits
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day of Surgery to 30 days postoperativeOutcome measures
| Measure |
Negative Pressure Wound Therapy
n=222 Participants
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
|
Standard Dressing
n=219 Participants
After standard cesarean section completed patients will have standard dressing placed.
|
|---|---|---|
|
Number of Participants With Morbid Outcomes After Delivery
Readmission
|
12 Participants
|
9 Participants
|
|
Number of Participants With Morbid Outcomes After Delivery
Postoperative antimicrobials
|
33 Participants
|
39 Participants
|
|
Number of Participants With Morbid Outcomes After Delivery
Reoperation for I and D/Extirpation
|
14 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day of Surgery to 30 days postoperativeCochran Mantel-Hanzel measures used to compare interactions between scheduled and unscheduled cesarean sections stratified by icNPT and standard dressing, for wound morbidity
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=37 Participants
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
|
Standard Dressing
n=42 Participants
After standard cesarean section completed patients will have standard dressing placed.
|
|---|---|---|
|
Number of Participants With Scheduled and Unscheduled Cesarean Section
Scheduled
|
12 Participants
|
12 Participants
|
|
Number of Participants With Scheduled and Unscheduled Cesarean Section
Unscheduled
|
25 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Day of Surgery to 30 days postoperativeCochran-Mantel-Haenzel test for interactions between pfannenstiel and midline abdominal incisions stratified by icNPT vs Standard dressing, for wound morbidity
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=37 Participants
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
|
Standard Dressing
n=42 Participants
After standard cesarean section completed patients will have standard dressing placed.
|
|---|---|---|
|
Number of Participants With Pfannenstiel Versus Midline Abdominal Incisions for Cesarian Section
pfannenstiel
|
3 Participants
|
8 Participants
|
|
Number of Participants With Pfannenstiel Versus Midline Abdominal Incisions for Cesarian Section
midline
|
34 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Day of Surgery to 30 days postoperativeCochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard dressing stratified by Ruptured vs Unruptured membranes
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=37 Participants
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
|
Standard Dressing
n=42 Participants
After standard cesarean section completed patients will have standard dressing placed.
|
|---|---|---|
|
Number of Patients With Ruptured and Unruptured Membranes Prior to Cesarean Section
Ruptured
|
15 Participants
|
17 Participants
|
|
Number of Patients With Ruptured and Unruptured Membranes Prior to Cesarean Section
Unruptured
|
22 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Day of Surgery to 30 days postoperativeCochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard dressing stratified by patients in labor and patients not in labor
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=37 Participants
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
|
Standard Dressing
n=42 Participants
After standard cesarean section completed patients will have standard dressing placed.
|
|---|---|---|
|
Number of Patients in Labor Versus no Labor Prior to Cesarean Section
Labor
|
15 Participants
|
17 Participants
|
|
Number of Patients in Labor Versus no Labor Prior to Cesarean Section
No labor
|
22 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Day of Surgery to 30 days postoperativeCochran-Mantel-Haenzel measure used to compare interaction between patients with hypertension versus no hypertension stratified by icNPT versus standard dressing, in wound morbidity
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=37 Participants
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
|
Standard Dressing
n=42 Participants
After standard cesarean section completed patients will have standard dressing placed.
|
|---|---|---|
|
Number of Patients With Hypertension Versus no Hypertension
Hypertension
|
8 Participants
|
8 Participants
|
|
Number of Patients With Hypertension Versus no Hypertension
No Hypertension
|
29 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Day of Surgery to 30 days postoperativeCochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard wound dressings stratified by women with insulin requiring diabetes and no insulin requiring Diabetes.
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=37 Participants
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
|
Standard Dressing
n=42 Participants
After standard cesarean section completed patients will have standard dressing placed.
|
|---|---|---|
|
Number of Patients With Insulin Requiring Diabetes Versus no Insulin Requiring Diabetes
Insulin Diabetes
|
5 Participants
|
7 Participants
|
|
Number of Patients With Insulin Requiring Diabetes Versus no Insulin Requiring Diabetes
No Diabetes
|
32 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Day of Surgery to 30 days postoperativeCochran-Mantel-Haenzel measure used to estimate interaction between chorioamnionitis and no chorioamnionitis stratified by icNPT and standard dressing, for wound morbidity
Outcome measures
| Measure |
Negative Pressure Wound Therapy
n=37 Participants
After standard cesarean section completed patients will have Prevena negative pressure wound therapy system placed.
Negative pressure wound therapy: Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
|
Standard Dressing
n=42 Participants
After standard cesarean section completed patients will have standard dressing placed.
|
|---|---|---|
|
Number of Patients With Chorioamnionitis Versus no Chorioamnionitis
chorioamnionitis
|
4 Participants
|
3 Participants
|
|
Number of Patients With Chorioamnionitis Versus no Chorioamnionitis
no chorioamnionitis
|
33 Participants
|
39 Participants
|
Adverse Events
Negative Pressure Wound Therapy
Serious events: 0 serious events
Other events: 0 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
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 8\. PUBLICATION AND REPORTS ON DATA; COPYRIGHTS A. Prior to public presentation or submission to a journal, Investigator will submit for review to Company...content of any manuscript for publication, abstract, or presentation containing data and results of the Study, ...such review is for the limited purposes of ensuring that the manuscript accurately describes the Product and does not contain any Confidential lnformation...Investigator will have the unfettered right to publish.
- Publication restrictions are in place
Restriction type: OTHER