An interventional study of Negative pressure wound therapy (PREVENA Incision Management Therapy System) and Standard dressing in Obesity, Morbid, Wound Infection and Wound Complication, sponsored by Medstar Health Research Institute. Terminated at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by Medstar Health Research Institute · Not applicable, Interventional, and Prevention
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 213 studies in Obesity, Morbid with a site in United States — 28 open to participants now, 36 under way, 1 of them phase 3. Obesity, Morbid · United States.
Among the 213 studies in Obesity, Morbid with a site in United States, this one is the 96th largest by enrollment of the 150 interventional ones that give a count, is one of 11 that started in 2017, is one of 107 with no phase, and was the 132nd registered.
941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.
Browse Obesity, Morbid studies →28 of the 213 studies in Obesity, Morbid with a site in United States are open now. Recruiting first, the newest first:
Christopher C. Thompson, MD, MSc · Sites in United States
Ages 18–90
The Cleveland Clinic · Sites in United States
Ages 18–70
University of Maryland, Baltimore · Sites in United States
Ages 18+ · Women only
University of Missouri-Columbia · Sites in United States
Ages 18+
Salvador Navarrete · Sites in United States
Ages 18–70
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 110 Obesity, Morbid studies recruiting now, 21 (19%) set no upper age limit and 84 (76%) stop at 75 or younger; 8 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 50 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
213 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 11 · Phase 3 8 · Phase 4 13
First in 1980; this study’s year is marked. 11 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 25 is below the median of 62 across 602 interventional studies indexed under Obesity, Morbid.
Median enrollment 39 across the 150 interventional studies, 50 across the 63 observational. Of the 147 that completed or were terminated, 56 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
22 of 213 have an industry lead sponsor. The 10 most frequent:
Medstar Health Research Institute is the lead sponsor of 161 studies on the registry; 31 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 7 (50%) have results posted.
Medstar Health Research Institute has 1 study filed under Obesity, Morbid — fewer than ten, so there is no comparison to draw.
8 of the studies in Obesity, Morbid with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06199154University of Maryland, BaltimoreInduction of Labor in Morbidly Obese Patients | 2026-12 |
| NCT05711758Christopher C. Thompson, MD, MScEfficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure | 2026-12 |
| NCT02602769Columbia UniversityWhole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome | 2026-12 |
| NCT05215886University of California, DavisCognitive Impairment, Obesity, and the Effects of Bariatric Surgery | 2026-12-31 |
| NCT03868592Mayo ClinicLong-term, Substantial Weight Loss and Insulin Regulation of Lipolysis | 2027-05 |
Add all 8 to your calendar (.ics) → With an account.
Among the 213 studies in Obesity, Morbid with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women receiving NPWT will have a PREVENA Incision Management Therapy System applied directly onto their skin over the closed incision after delivery.
Device: Negative pressure wound therapy (PREVENA Incision Management Therapy System)
Standard dressing
Device: Standard dressing
After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.
After cesarean delivery, women in the intervention group will receive standard dressing.
Composite Wound Complication
Any of wound infection, seroma/hematoma, wound separation \>1 cm, and wound dehiscence
Time frame: Four weeks postpartum
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.
Time frame: Four weeks postpartum
Demographic Data
Age, race/ethnicity, parity
Time frame: At time time of admission
Maternal Body Mass Index
Prepregnancy and at the time of delivery
Time frame: At time time of admission
Gestational Age at Delivery
We were unable to adequately recruit for this study. Study was closed.
Time frame: At time time of admission
Maternal Comorbidities
Renal disease, hypertension, diabetes, psychiatric history, sleep apnea, history of venous thromboembolism
Time frame: At time time of admission
Antenatal Complications
Gestational diabetes, preeclampsia
Time frame: At time time of admission
Number of Previous Cesarean Deliveries
We were unable to adequately recruit for this study. Study was closed.
Time frame: At time time of admission
Indication for Cesarean Delivery
Failed induction, arrest of active phase, arrest of descent, malpresentation, repeat cesarean delivery, desired cesarean
Time frame: 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)
Time frame: At the time of admission
Labor Duration
We were unable to adequately recruit for this study. Study was closed.
Time frame: At the time of cesarean delivery
Endometritis
We were unable to adequately recruit for this study. Study was closed.
Time frame: Four weeks postpartum
Length of Rupture of Membranes
We were unable to adequately recruit for this study. Study was closed.
Time frame: At the time of cesarean delivery
Operative Time
We were unable to adequately recruit for this study. Study was closed.
Time frame: At the time of cesarean delivery
Intraoperative Complication
Postpartum hemorrhage, transfusion, ureteral injury, bladder injury, B-lynch suture, and hysterectomy
Time frame: At the time of cesarean delivery
Type of Skin Incision
We were unable to adequately recruit for this study. Study was closed.
Time frame: At the time of cesarean delivery
Type of Uterine Incision
We were unable to adequately recruit for this study. Study was closed.
Time frame: At the time of cesarean delivery
Type of Fascia Closure
We were unable to adequately recruit for this study. Study was closed.
Time frame: At the time of cesarean delivery
Type of Subcutaneous Closure
We were unable to adequately recruit for this study. Study was closed.
Time frame: At the time of cesarean delivery
Administration of Preoperative Antibiotics
Cefazolin, Azithromycin, Clindamycin, Gentamicin, and other
Time frame: At the time of cesarean delivery
Quantitative Blood Loss
We were unable to adequately recruit for this study. Study was closed.
Time frame: At the time of cesarean delivery
| Milestone | Negative Pressure Wound Therapy (NPWT) | Standard Dressing |
|---|---|---|
| Started | 0 | 0 |
| Completed | 0 | 0 |
| Not completed | 0 | 0 |
Any of wound infection, seroma/hematoma, wound separation \>1 cm, and wound dehiscence
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Age, race/ethnicity, parity
Results for this outcome have not been posted.
Prepregnancy and at the time of delivery
Results for this outcome have not been posted.
We were unable to adequately recruit for this study. Study was closed.
Results for this outcome have not been posted.
Renal disease, hypertension, diabetes, psychiatric history, sleep apnea, history of venous thromboembolism
Results for this outcome have not been posted.
Gestational diabetes, preeclampsia
Results for this outcome have not been posted.
We were unable to adequately recruit for this study. Study was closed.
Results for this outcome have not been posted.
Failed induction, arrest of active phase, arrest of descent, malpresentation, repeat cesarean delivery, desired cesarean
Results for this outcome have not been posted.
Spontaneous labor, rupture of membranes, induction of labor, scheduled cesarean delivery, fetal condition (oligohydroamnios, growth restriction, non reassuring fetal heart tracing)
Results for this outcome have not been posted.
We were unable to adequately recruit for this study. Study was closed.
Results for this outcome have not been posted.
We were unable to adequately recruit for this study. Study was closed.
Results for this outcome have not been posted.
We were unable to adequately recruit for this study. Study was closed.
Results for this outcome have not been posted.
We were unable to adequately recruit for this study. Study was closed.
Results for this outcome have not been posted.
Postpartum hemorrhage, transfusion, ureteral injury, bladder injury, B-lynch suture, and hysterectomy
Results for this outcome have not been posted.
We were unable to adequately recruit for this study. Study was closed.
Results for this outcome have not been posted.
We were unable to adequately recruit for this study. Study was closed.
Results for this outcome have not been posted.
We were unable to adequately recruit for this study. Study was closed.
Results for this outcome have not been posted.
We were unable to adequately recruit for this study. Study was closed.
Results for this outcome have not been posted.
Cefazolin, Azithromycin, Clindamycin, Gentamicin, and other
Results for this outcome have not been posted.
We were unable to adequately recruit for this study. Study was closed.
Results for this outcome have not been posted.
Collected over The study was terminated due to insufficient enrollment. No study data are available.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Negative Pressure Wound Therapy (NPWT) | — | — | — |
| Standard Dressing | — | — | — |
The study was terminated due to insufficient enrollment. No study data are available.
| Age, Categorical | Negative Pressure Wound Therapy (NPWT) | Standard Dressing | Total |
|---|---|---|---|
| <=18 years | — | — | — |
| Between 18 and 65 years | — | — | — |
| >=65 years | — | — | — |
| Age, Continuous | Negative Pressure Wound Therapy (NPWT) | Standard Dressing | Total |
|---|
| Sex: Female, Male | Negative Pressure Wound Therapy (NPWT) | Standard Dressing | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
| Race and Ethnicity Not Collected | Negative Pressure Wound Therapy (NPWT) | Standard Dressing | Total |
|---|
| Region of Enrollment(participants) | Negative Pressure Wound Therapy (NPWT) | Standard Dressing | Total |
|---|
| Parity | Negative Pressure Wound Therapy (NPWT) | Standard Dressing | Total |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Jun 2019, 20 months.
Results were first posted in Oct 2020, 1 year 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medstar Health Research Institute →