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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: Clinical Trial NA study, sponsored by Medstar Health Research Institute.
NCT03269968 is a NA study that was terminated before completion, run by Medstar Health Research Institute. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Any of wound infection, seroma/hematoma, wound separation \>1 cm, and wound dehiscence
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 |
Why NCT03269968 stopped before completion
NCT03269968 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03269968's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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