Obesity, Morbid Clinical Trial
Official title:
Use of Negative Pressure Wound Therapy in Morbidly Obese Women After Cesarean Delivery
NCT number | NCT03269968 |
Other study ID # | 2017-137 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | October 3, 2017 |
Est. completion date | June 30, 2019 |
Verified date | June 2020 |
Source | Medstar Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 25 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Body Mass Index =40 kg/m2 at time of delivery - Delivered by cesarean delivery - 18 years or later Exclusion Criteria: - Chorioamnionitis - Silver allergy - Inability to follow up |
Country | Name | City | State |
---|---|---|---|
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Medstar Health Research Institute | Amenity Health, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Demographic Data | Age, race/ethnicity, parity | At time time of admission | |
Other | Maternal Body Mass Index | Prepregnancy and at the time of delivery | At time time of admission | |
Other | Gestational Age at Delivery | We were unable to adequately recruit for this study. Study was closed. | At time time of admission | |
Other | Maternal Comorbidities | Renal disease, hypertension, diabetes, psychiatric history, sleep apnea, history of venous thromboembolism | At time time of admission | |
Other | Antenatal Complications | Gestational diabetes, preeclampsia | At time time of admission | |
Other | Number of Previous Cesarean Deliveries | We were unable to adequately recruit for this study. Study was closed. | At time time of admission | |
Other | 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 | |
Other | 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 | |
Other | Labor Duration | We were unable to adequately recruit for this study. Study was closed. | At the time of cesarean delivery | |
Other | Endometritis | We were unable to adequately recruit for this study. Study was closed. | Four weeks postpartum | |
Other | Length of Rupture of Membranes | We were unable to adequately recruit for this study. Study was closed. | At the time of cesarean delivery | |
Other | Operative Time | We were unable to adequately recruit for this study. Study was closed. | At the time of cesarean delivery | |
Other | Intraoperative Complication | Postpartum hemorrhage, transfusion, ureteral injury, bladder injury, B-lynch suture, and hysterectomy | At the time of cesarean delivery | |
Other | Type of Skin Incision | We were unable to adequately recruit for this study. Study was closed. | At the time of cesarean delivery | |
Other | Type of Uterine Incision | We were unable to adequately recruit for this study. Study was closed. | At the time of cesarean delivery | |
Other | Type of Fascia Closure | We were unable to adequately recruit for this study. Study was closed. | At the time of cesarean delivery | |
Other | Type of Subcutaneous Closure | We were unable to adequately recruit for this study. Study was closed. | At the time of cesarean delivery | |
Other | Administration of Preoperative Antibiotics | Cefazolin, Azithromycin, Clindamycin, Gentamicin, and other | At the time of cesarean delivery | |
Other | Quantitative Blood Loss | We were unable to adequately recruit for this study. Study was closed. | At the time of cesarean delivery | |
Primary | Composite Wound Complication | Any of wound infection, seroma/hematoma, wound separation >1 cm, and wound dehiscence | 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. | Four weeks postpartum |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04517591 -
Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study
|
N/A | |
Active, not recruiting |
NCT04583683 -
Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities
|
N/A | |
Completed |
NCT01550601 -
Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity
|
N/A | |
Completed |
NCT03638843 -
Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2
|
N/A | |
Recruiting |
NCT05917795 -
Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
|
N/A | |
Completed |
NCT03339791 -
Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial
|
N/A | |
Recruiting |
NCT05711758 -
Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure
|
||
Not yet recruiting |
NCT04209842 -
Effectiveness Gastric Balloon in Obese Adolescents
|
N/A | |
Recruiting |
NCT03100292 -
Korean OBEsity Surgical Treatment Study
|
N/A | |
Active, not recruiting |
NCT04357119 -
Common Limb Length in One-anastomosis Gastric Bypass
|
N/A | |
Completed |
NCT03210207 -
Gastric Plication in Mexican Patients
|
N/A | |
Completed |
NCT02590406 -
EPO2-A: Evaluation of Pre-Oxygenation in Morbid Obesity: Effect of Position and Positive Pressure Ventilation
|
N/A | |
Completed |
NCT01840020 -
BAR-trial: Bioavailability of Ethanol Following Bariatric Surgery
|
||
Completed |
NCT01183975 -
Swedish Adjustable Gastric Banding Observational Cohort Study
|
N/A | |
Completed |
NCT03872024 -
Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients
|
N/A | |
Terminated |
NCT05993169 -
Body Composition Optimization Intervention RCT
|
N/A | |
Not yet recruiting |
NCT05974995 -
Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer
|
N/A | |
Recruiting |
NCT05554016 -
The UFO (Ultra Processed Foods in Obesity) Project
|
||
Not yet recruiting |
NCT05499949 -
The Franciscus Obesity NASH Study
|
||
Completed |
NCT05519423 -
Investigation of the Effectiveness of Whatsapp-Based Physical Activity Incentive Program in Morbidly Obese Individuals
|
N/A |