Trial Outcomes & Findings for Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery (NCT NCT03269968)
NCT ID: NCT03269968
Last Updated: 2020-10-19
Results Overview
Any of wound infection, seroma/hematoma, wound separation \>1 cm, and wound dehiscence
TERMINATED
NA
25 participants
Four weeks postpartum
2020-10-19
Participant Flow
The study was terminated due to insufficient enrollment. No study data are available.
Participant milestones
| Measure |
Negative Pressure Wound Therapy (NPWT)
Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.
Negative pressure wound therapy (PREVENA Incision Management Therapy System): After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.
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Standard Dressing
Standard dressing
Standard dressing: After cesarean delivery, women in the intervention group will receive standard dressing.
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Overall Study
STARTED
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0
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Four weeks postpartumPopulation: The study was terminated due to insufficient enrollment. No study data are available.
Any of wound infection, seroma/hematoma, wound separation \>1 cm, and wound dehiscence
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Four weeks postpartumPopulation: The study was terminated due to insufficient enrollment. No study data are available.
Through patient surveys administered prior to hospital discharge and at four weeks post-operative investigators will evaluate patient satisfaction with wound healing. Satisfactory measures will include how well participants think incision healed mobility after surgery, pain control, and the incision's appearance. Patients were also asked if they had emergency room visits or hospital readmissions. For patients who received NPWT investigators will assess the ease of use, comfort, and perception of its efficacy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At time time of admissionAge, race/ethnicity, parity
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At time time of admissionPrepregnancy and at the time of delivery
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At time time of admissionWe were unable to adequately recruit for this study. Study was closed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At time time of admissionRenal disease, hypertension, diabetes, psychiatric history, sleep apnea, history of venous thromboembolism
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At time time of admissionGestational diabetes, preeclampsia
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At time time of admissionWe were unable to adequately recruit for this study. Study was closed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At time time of cesarean deliveryFailed induction, arrest of active phase, arrest of descent, malpresentation, repeat cesarean delivery, desired cesarean
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of admissionSpontaneous labor, rupture of membranes, induction of labor, scheduled cesarean delivery, fetal condition (oligohydroamnios, growth restriction, non reassuring fetal heart tracing)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of cesarean deliveryWe were unable to adequately recruit for this study. Study was closed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Four weeks postpartumWe were unable to adequately recruit for this study. Study was closed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of cesarean deliveryWe were unable to adequately recruit for this study. Study was closed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of cesarean deliveryWe were unable to adequately recruit for this study. Study was closed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of cesarean deliveryPostpartum hemorrhage, transfusion, ureteral injury, bladder injury, B-lynch suture, and hysterectomy
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of cesarean deliveryWe were unable to adequately recruit for this study. Study was closed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of cesarean deliveryWe were unable to adequately recruit for this study. Study was closed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of cesarean deliveryWe were unable to adequately recruit for this study. Study was closed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of cesarean deliveryWe were unable to adequately recruit for this study. Study was closed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of cesarean deliveryCefazolin, Azithromycin, Clindamycin, Gentamicin, and other
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of cesarean deliveryWe were unable to adequately recruit for this study. Study was closed.
Outcome measures
Outcome data not reported
Adverse Events
Negative Pressure Wound Therapy (NPWT)
Standard Dressing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place