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| Name | Class |
|---|---|
| Amenity Health, Inc. | INDUSTRY |
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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.
Obese women are more likely to be delivered by cesarean than normal weight women and are at increased risk for operative morbidity including wound complications. Negative pressure wound therapy (NPWT) has been shown to improve wound healing, decrease the rate of surgical site infection, sero-hematoma formation, and reoperation rates. The potential benefit of NPWT in high-risk wounds after cesarean delivery is unclear. Investigators propose conducting a single-site randomized controlled trial to examine the efficacy of NPWT after cesarean delivery in morbidly obese women (BMI ≥ 40 kg/m2).
Specific aims of the study include determining if NPWT used in morbidly obese women after cesarean delivery improves postoperative wound complication rate and to assess patient satisfaction with NPWT. The primary outcome is a composite wound complication rate defined as having one of the following occur within four weeks of delivery: wound infection, seroma, hematoma, separation, or dehiscence.
Participants will be randomized in a 1:1 ratio to either NPWT or standard surgical dressing. Women receiving NWPT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery. Women randomized to the standard surgical dressing will have a TELFA non-adhesive dressing with a 3M Tegaderm transparent film adhesive dressing. In addition, an abdominal pad (ABD) with foam tape may be applied to provide additional pressure if needed.
The wound will be assessed at the time of dressing removal or hospital discharge and at four weeks postoperative. Participants will also take a patient satisfaction survey regarding wound healing experience at four-week follow-up. For the study, investigators are planning to enroll 482 patients (241 per arm) to demonstrate a decrease in the wound complication rate by 50%. This study will help clinicians better manage obese women in pregnancy and hopefully improve wound outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative pressure wound therapy (NPWT) | Experimental | Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery. |
|
| Standard dressing | Placebo Comparator | Standard dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative pressure wound therapy (PREVENA Incision Management Therapy System) | Device | After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Wound Complication | Any of wound infection, seroma/hematoma, wound separation >1 cm, and wound dehiscence | Four weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Survey | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic Data | Age, race/ethnicity, parity | At time time of admission |
| Maternal Body Mass Index | Prepregnancy and at the time of delivery |
Inclusion Criteria:
Exclusion Criteria:
Pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Rachael T Overcash, MD, MPH | Medstar Health Research Institute | Principal Investigator |
| Iqbal N Iqbal, MD | Medstar Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
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The study was terminated due to insufficient enrollment. No study data are available.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Sep 24, 2019 |
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Study participants will be enrolled in a 1:1 ratio to either Negative Pressure Wound Therapy or standard dressing. Randomization will occur prior to delivery using a computer randomization system.
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| Standard dressing | Device | After cesarean delivery, women in the intervention group will receive standard dressing. |
|
| Four weeks postpartum |
| At time time of admission |
| Gestational Age at Delivery | We were unable to adequately recruit for this study. Study was closed. | At time time of admission |
| Maternal Comorbidities | Renal disease, hypertension, diabetes, psychiatric history, sleep apnea, history of venous thromboembolism | At time time of admission |
| Antenatal Complications | Gestational diabetes, preeclampsia | At time time of admission |
| Number of Previous Cesarean Deliveries | We were unable to adequately recruit for this study. Study was closed. | At time time of admission |
| Indication for Cesarean Delivery | Failed induction, arrest of active phase, arrest of descent, malpresentation, repeat cesarean delivery, desired cesarean | At time time of cesarean delivery |
| Reason for Admission | Spontaneous labor, rupture of membranes, induction of labor, scheduled cesarean delivery, fetal condition (oligohydroamnios, growth restriction, non reassuring fetal heart tracing) | At the time of admission |
| Labor Duration | We were unable to adequately recruit for this study. Study was closed. | At the time of cesarean delivery |
| Endometritis | We were unable to adequately recruit for this study. Study was closed. | Four weeks postpartum |
| Length of Rupture of Membranes | We were unable to adequately recruit for this study. Study was closed. | At the time of cesarean delivery |
| Operative Time | We were unable to adequately recruit for this study. Study was closed. | At the time of cesarean delivery |
| Intraoperative Complication | Postpartum hemorrhage, transfusion, ureteral injury, bladder injury, B-lynch suture, and hysterectomy | At the time of cesarean delivery |
| Type of Skin Incision | We were unable to adequately recruit for this study. Study was closed. | At the time of cesarean delivery |
| Type of Uterine Incision | We were unable to adequately recruit for this study. Study was closed. | At the time of cesarean delivery |
| Type of Fascia Closure | We were unable to adequately recruit for this study. Study was closed. | At the time of cesarean delivery |
| Type of Subcutaneous Closure | We were unable to adequately recruit for this study. Study was closed. | At the time of cesarean delivery |
| Administration of Preoperative Antibiotics | Cefazolin, Azithromycin, Clindamycin, Gentamicin, and other | At the time of cesarean delivery |
| Quantitative Blood Loss | We were unable to adequately recruit for this study. Study was closed. | At the time of cesarean delivery |
| FG001 | Standard Dressing | Standard dressing Standard dressing: After cesarean delivery, women in the intervention group will receive standard dressing. |
| COMPLETED |
|
| NOT COMPLETED |
|
The study was terminated due to insufficient enrollment. No study data are available.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard Dressing | Standard dressing Standard dressing: After cesarean delivery, women in the intervention group will receive standard dressing. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| ||||||||||||||||||||||
| Age, Continuous | |||||||||||||||||||||||
| Sex: Female, Male |
| ||||||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | ||||||||||||||||||||||
| Region of Enrollment | participants |
| |||||||||||||||||||||
| Parity |
| 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 | Composite Wound Complication | Any of wound infection, seroma/hematoma, wound separation >1 cm, and wound dehiscence | The study was terminated due to insufficient enrollment. No study data are available. | Posted | Four weeks postpartum |
|
| ||||||||||||||||||||||
| Secondary | Patient Survey | 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. | The study was terminated due to insufficient enrollment. No study data are available. | Posted | Four weeks postpartum |
|
| ||||||||||||||||||||||
| Other Pre-specified | Demographic Data | Age, race/ethnicity, parity | Not Posted | At time time of admission | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Maternal Body Mass Index | Prepregnancy and at the time of delivery | Not Posted | At time time of admission | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Gestational Age at Delivery | We were unable to adequately recruit for this study. Study was closed. | Not Posted | At time time of admission | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Maternal Comorbidities | Renal disease, hypertension, diabetes, psychiatric history, sleep apnea, history of venous thromboembolism | Not Posted | At time time of admission | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Antenatal Complications | Gestational diabetes, preeclampsia | Not Posted | At time time of admission | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Number of Previous Cesarean Deliveries | We were unable to adequately recruit for this study. Study was closed. | Not Posted | At time time of admission | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Indication for Cesarean Delivery | Failed induction, arrest of active phase, arrest of descent, malpresentation, repeat cesarean delivery, desired cesarean | Not Posted | At time time of cesarean delivery | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Reason for Admission | Spontaneous labor, rupture of membranes, induction of labor, scheduled cesarean delivery, fetal condition (oligohydroamnios, growth restriction, non reassuring fetal heart tracing) | Not Posted | At the time of admission | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Labor Duration | We were unable to adequately recruit for this study. Study was closed. | Not Posted | At the time of cesarean delivery | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Endometritis | We were unable to adequately recruit for this study. Study was closed. | Not Posted | Four weeks postpartum | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Length of Rupture of Membranes | We were unable to adequately recruit for this study. Study was closed. | Not Posted | At the time of cesarean delivery | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Operative Time | We were unable to adequately recruit for this study. Study was closed. | Not Posted | At the time of cesarean delivery | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Intraoperative Complication | Postpartum hemorrhage, transfusion, ureteral injury, bladder injury, B-lynch suture, and hysterectomy | Not Posted | At the time of cesarean delivery | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Type of Skin Incision | We were unable to adequately recruit for this study. Study was closed. | Not Posted | At the time of cesarean delivery | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Type of Uterine Incision | We were unable to adequately recruit for this study. Study was closed. | Not Posted | At the time of cesarean delivery | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Type of Fascia Closure | We were unable to adequately recruit for this study. Study was closed. | Not Posted | At the time of cesarean delivery | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Type of Subcutaneous Closure | We were unable to adequately recruit for this study. Study was closed. | Not Posted | At the time of cesarean delivery | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Administration of Preoperative Antibiotics | Cefazolin, Azithromycin, Clindamycin, Gentamicin, and other | Not Posted | At the time of cesarean delivery | Participants | ||||||||||||||||||||||||
| Other Pre-specified | Quantitative Blood Loss | We were unable to adequately recruit for this study. Study was closed. | Not Posted | At the time of cesarean delivery | Participants |
The study was terminated due to insufficient enrollment. No study data are available.
The study was terminated due to insufficient enrollment. No study data are available.
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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 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Standard Dressing | Standard dressing Standard dressing: After cesarean delivery, women in the intervention group will receive standard dressing. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachael Overcash | MedStar Health Reseach Institute | 202-877-6093 | rachael.overcash@medstar.net |
| Sep 24, 2020 |
| Prot_ICF_000.pdf |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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| Counts |
|---|
| Participants |
|