Trials / Terminated
TerminatedNCT02799667
Do Single Use Negative Pressure Dressings Reduce Wound Complications in Obese Women After Cesarean Delivery
Randomized Controlled Trial: Do Single Use Negative Pressure Dressings Reduce Wound Complications in Women With a BMI >40 kg/m2 Undergoing Cesarean Delivery at a Tertiary Medical Center?
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- Tufts Medical Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The investigators aim to show that single use negative pressure dressings can decrease the rate of wound complications in obese women (BMI \> 40 kg/m2) undergoing cesarean delivery at a tertiary medical center by randomizing women to receive either a single use negative pressure dressing or the standard dressing after cesarean delivery.
Detailed description
Subjects admitted to L+D for obstetric or medical indications at a tertiary medical center with a BMI \> 40 kg/m2 will be asked to participate in a study on post surgical dressings and wound outcomes if they undergo cesarean delivery. Subjects will be randomized to either study arm at the time of fascial closure during cesarean delivery. Post operative care will not be altered. Incisions will be evaluated prior to hospital discharge. Subjects will present for a wound evaluation 2 weeks post operatively, and receive phone calls to assess outcomes at both 2 and 6 weeks post operatively.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Standard Dressing | Patients are randomized to the standard dressing at the time of fascial closure. |
| DEVICE | Negative Pressure Wound Therapy Dressing | Patients are randomized to the NPWT at the time of fascial closure. |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2019-03-31
- Completion
- 2019-03-31
- First posted
- 2016-06-15
- Last updated
- 2021-02-21
- Results posted
- 2021-02-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02799667. Inclusion in this directory is not an endorsement.