Caesarean Section Wound Separation, Major Puerperal Infection, Postpartum, Wound Complications, Wound Infection, Wound Seroma
Conditions
Keywords
Cesarean delivery, Postpartum infection, Wound complications, Wound seroma, Wound separation, Wound infection, Negative pressure
Brief summary
This study is aimed at determining whether or not the use of a wound suction device placed on the cesarean incision instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. The study will first look at the infection and wound complication rate in women 6 months prior to the start date of the study by reviewing charts of women who have undergone a cesarean section. The study involves placing a single use, portable wound vacuum over the cesarean section incision and keeping it in place for 72h. The investigators will then compare the rates of wound infection and wound complications between these two groups. It is our hypothesis that negative pressure wound systems will decrease the wound infection and complication rate in this high risk population.
Detailed description
Infectious complications have been found to be five times higher in women undergoing a cesarean delivery compared to a vaginal delivery. Known risk factors for wound complications are obesity, premature rupture of membranes, diabetes mellitus, hypertensive disorders, emergency cesarean delivery, twin delivery, chorioamnionitis, increased surgical blood loss and preeclampsia. This study is aimed at determining whether or not the use of a suction device placed on the wound instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. The investigators will compare the results from the participants of this study to an existing data set of historical controls who underwent cesarean delivery. The study involves placing a single use, portable negative wound pressure system kept in place while in the hospital after surgery (on average 48-72 hours) in women who meet criteria for increased risk of wound complications. The investigators will then compare the rates of wound infection and wound complications between these two groups.
Interventions
DEVICEPrevena negative pressure wound system
Placement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication
Sponsors
Kinetic Concepts, Inc.
Abbey Hardy-Fairbanks
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 18 years old or older * Having a cesarean delivery * Has one or more of the following conditions: * BMI \> 30 * Anemia * Preeclampsia (sever or mild) * Hemolysis, elevated liver enzymes and low platelets (HELLP) * Urgent procedure * Rupture of membranes prior to surgery for \> 4 hours * Chorioamnionitis * Hypertension * Diabetes (Gestational or pre-gestational) * Dense adhesive disease
Exclusion criteria
* Age \< 18 years old * Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Complication Rate | Up to 6 weeks from time of surgery | Wound infection, separation or deep infection |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Negative Pressure Pump Will have the Prevena negative pressure wound system placed at the time of surgery. | 110 |
| Total | 110 |
Baseline characteristics
| Characteristic | Negative Pressure Pump |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 110 Participants |
| Age, Continuous | 30.8 years STANDARD_DEVIATION 6 |
| Region of Enrollment United States | 110 participants |
| Sex: Female, Male Female | 110 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 110 |
| other Total, other adverse events | 0 / 110 |
| serious Total, serious adverse events | 1 / 110 |
Outcome results
Primary
Wound Complication Rate
Wound infection, separation or deep infection
Time frame: Up to 6 weeks from time of surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Negative Pressure Pump | Wound Complication Rate | wound infection | 3 participants |
| Negative Pressure Pump | Wound Complication Rate | Endometritis | 1 participants |
| Negative Pressure Pump | Wound Complication Rate | Wound separation | 3 participants |
| Negative Pressure Pump | Wound Complication Rate | All wound complications (separation and infection) | 6 participants |