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NCT03269968 · ClinicalTrials.gov registry record · NA
Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery
A NA study, sponsored by Medstar Health Research Institute.
- Terminated
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT03269968 is a NA study that was terminated before completion, run by Medstar Health Research Institute. The registered enrollment target is 25 participants.
The verdict
NCT03269968, a NA study, was terminated before completion, sponsored by Medstar Health Research Institute.
- TERMINATED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
Obese women are more likely have a cesarean delivery and develop subsequent wound complications than normal weight women. Negative pressure wound therapy (NPWT) has been shown to improve surgical wound healing, but this device has not been adequately studied in cesarean deliveries. The aim of our study is to determine the efficacy of NPWT in morbidly obese women after cesarean delivery. Investigators will be randomizing women with a BMI \> 40 kg/m2 in a 1:1 ratio to either NPWT (the PREVENA Incision management therapy system Pre 1001 Us) or standard dressing after their cesarean delivery at MedStar Washington Hospital Center. The NPWT will be left in place for a minimum of four days but not to exceed seven days. The standard dressing is typically removed on postoperative day one or two. The primary outcome is a wound complication defined as the formation of a wound infection, seroma, hematoma, separation, or dehiscence from delivery to 4 weeks postpartum. Investigators will also administer a patient satisfaction survey regarding their wound healing experience.
Interventions
- DEVICE Negative pressure wound therapy (PREVENA Incision Management Therapy System)
- DEVICE Standard dressing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2017-10-03 |
| Est. Completion | 2019-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03269968
The ClinicalTrials.gov registry entry for NCT03269968 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medstar Health Research Institute, which has 115 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Negative pressure wound therapy (PREVENA Incision Management Therapy System) is the first listed.
NCT03269968 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03269968 about?
NCT03269968 is a clinical study titled "Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery". Obese women are more likely have a cesarean delivery and develop subsequent wound complications than normal weight women. Negative pressure wound therapy (NPWT) has been shown to improve surgical wound healing, but this device has not been adequately studied in cesarean deliveries. The aim of our st...
What is the current status of trial NCT03269968?
This trial is currently terminated. It is a NA study. The enrollment target is 25 participants. The study started on 2017-10-03. Estimated completion is 2019-06-30.
What interventions are being tested in trial NCT03269968?
The interventions under investigation include: Negative pressure wound therapy (PREVENA Incision Management Therapy System) (DEVICE), Standard dressing (DEVICE).
Who is sponsoring clinical trial NCT03269968?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
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