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| Name | Class |
|---|---|
| Kinetic Concepts, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative pressure pump | Experimental | Will have the Prevena negative pressure wound system placed at the time of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevena negative pressure wound system | Device | Placement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound Complication Rate | Wound infection, separation or deep infection | Up to 6 weeks from time of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Tikkanen, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Negative Pressure Pump | Will have the Prevena negative pressure wound system placed at the time of surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Negative Pressure Pump | Will have the Prevena negative pressure wound system placed at the time of surgery. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wound Complication Rate | Wound infection, separation or deep infection | Posted | Number | participants | Up to 6 weeks from time of surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Negative Pressure Pump | Will have the Prevena negative pressure wound system placed at the time of surgery. Prevena negative pressure wound system: Placement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin irritation from negative pressure dressing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abbey Hardy-Fairbanks, MD | University of Iowa Hospitals and Clinics | 319-356-2291 | abbey-hardy-fairbanks@uiowa.edu |
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 110 |
| 1 |
| 110 |
| 0 |
| 110 |
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