NCT03269968

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 3, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 19, 2020

Completed
Last Updated

October 19, 2020

Status Verified

June 1, 2020

Enrollment Period

1.7 years

First QC Date

August 30, 2017

Results QC Date

September 24, 2020

Last Update Submit

September 24, 2020

Conditions

Obesity, MorbidWound InfectionWound Complication

Outcome Measures

Primary Outcomes (1)

  • Composite Wound Complication

    Any of wound infection, seroma/hematoma, wound separation \>1 cm, and wound dehiscence

    Four weeks postpartum

Secondary Outcomes (1)

  • Patient Survey

    Four weeks postpartum

Other Outcomes (19)

  • Demographic Data

    At time time of admission

  • Maternal Body Mass Index

    At time time of admission

  • Gestational Age at Delivery

    At time time of admission

  • +16 more other outcomes

Study Arms (2)

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.

Device: Negative pressure wound therapy (PREVENA Incision Management Therapy System)

Standard dressing

PLACEBO COMPARATOR

Standard dressing

Device: Standard dressing

Interventions

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.

Negative pressure wound therapy (NPWT)
Standard dressingDEVICE

After cesarean delivery, women in the intervention group will receive standard dressing.

Standard dressing

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index ≥40 kg/m2 at time of delivery
  • Delivered by cesarean delivery
  • years or later

You may not qualify if:

  • Chorioamnionitis
  • Silver allergy
  • Inability to follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Obesity, MorbidWound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInfections

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Results Point of Contact

Title
Rachael Overcash
Organization
MedStar Health Reseach Institute
rachael.overcash@medstar.net
202-877-6093

Study Officials

  • Rachael T Overcash, MD, MPH

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

  • Iqbal N Iqbal, MD

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 1, 2017

Study Start

October 3, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

October 19, 2020

Results First Posted

October 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)