NCT03816293

Brief Summary

Our goal is to provide data that will give surgeons and hospitals clear recommendations on the use of NPWT for Cesarean section, abdominal hysterectomy and colon surgeries in patients with diabetes and/or obesity. We also want to understand the patient experience with the dressing so that we can provide information that will enable clinicians to remove barriers to NPWT use. Additionally, we are seeking to use automated electronic medical record decision support to identify patients that will benefit most from the NPWT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,680

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

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

January 22, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

1.9 years

First QC Date

January 22, 2019

Last Update Submit

November 17, 2022

Conditions

Surgical Site InfectionObesityDiabetesCesarean Section Complications

Keywords

colon surgeryabdominal hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Surgical Site Infection Rate per 100 surgeries

    Superficial , Deep and organ space infections after surgery

    within 30 days after surgery

Secondary Outcomes (5)

  • Post Operative Length of Stay (days)

    within 30days after surgery

  • REadmission incidence and rate per 100 surgeries

    within 30 days

  • Seroma incidence and rate per 100 surgeries

    with in 30 days after surgery

  • Hematoma incidence and rate per 100 surgeries

    within 30 days after surgery

  • Dehiscence incidence and rate per 100 surgeries

    within 30 days after surgery

Study Arms (2)

Negative Pressure Wound Therapy

ACTIVE COMPARATOR

NPWT use on closed incision for 7 days after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity

Device: Negative Pressure Wound Therapy

Control Dressing

NO INTERVENTION

Standard dressing on closed incisions after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity

Interventions

Negative Pressure Wound TherapyDEVICE

Occlusive dressing with attached Prevena incision management with 125mmHg of negative pressure and cartridge to manage secretions

Also known as: Prevena Incision Management
Negative Pressure Wound Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A. Patients undergoing any of the below procedures:
  • C-section
  • abdominal hysterectomy
  • B. and either of the following medical conditions:
  • obesity, BMI \>30 kg/m2
  • diabetes type 1 or 2 Criteria for a diagnosis of diabetes: Diabetes noted in the problem list or the medical history or Patient is taking a medication as treatment for diabetes, consistent with NHSN criteria(10).

You may not qualify if:

  • Age less than 18 years
  • Infection present at the time of the surgery
  • Laparoscopic procedures with incisions \<6cm.
  • Patients using alternative NPWT device other than the PrevenaTM with 125 mm Hg negative pressure
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Illinois Hospital

Chicago, Illinois, 60612, United States

Location

University of Iowa Health System

Iowa City, Iowa, 52242, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Surgical Wound InfectionObesityDiabetes Mellitus

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Study Officials

  • Susan Bleasdale, MD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Randomized stepped wedge cluster but site
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Medicine

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 25, 2019

Study Start

May 1, 2019

Primary Completion

March 31, 2021

Study Completion

September 30, 2021

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

This is a study with waiver of consent data will be in aggregate without patient identifiers

Locations

US(5)