The Invia Motion at Cesarean Study

Medela INVIA Motion NPWT System for Prophylactic Use on Surgical Incision After Cesarean Delivery

To assess patient centered outcomes of the Medela INVIA Motion prophylactic NPWT system at cesarean delivery.

Study Overview

• Status: Completed
• Conditions: Negative Pressure Wound Therapy; Cesarean Section; Infection
• Intervention / Treatment: Device: Invia Motion

Detailed Description

This study will be a two center case series of women undergoing caesarean delivery conducted at two medical centers in Indianapolis, Indiana.

All patients meeting inclusion criteria will be included. All enrolled patients will receive the Medela INVIA Motion prophylactic NPWT device.

Visit A: Interventional Procedure All enrolled patients will receive the Medela INVIA Motion device placed by the patient's surgeon after the skin is closed with subcuticular suture or staples. Research staff and clinicians (labor & delivery and postpartum nurses, OR technicians, physicians, etc.) involved in the study will receive formal training on how to place and remove the prophylactic NPWT device.

Visit B: Post Procedure until Discharge Patients will be monitored daily while in the hospital by clinical staff and/or research staff for complications.

The negative pressure wound therapy dressing will be removed on the day of discharge. If the patient remains hospitalized for more than 7 days, the dressing will be removed on postoperative day 7.

Replacement of any dressing that is saturated. If a patient develops infection with the NPWT device in place the device will be removed and the patient given standard SSI therapy as outlined below.

Patients will be educated about the signs and symptoms of infection and other study outcomes and encouraged to call their provider if these should arise.

Research staff document inpatient course regarding SSI. Management of surgical site infections will follow the Practice Guidelines of the Infectious Diseases Society of America.

Visit C: Postpartum Follow Up

We will use active surveillance by research staff to ascertain surgical site infections:

Research staff will follow-up with the research participant at time of discharge or within 48 hours post discharge (postpartum day 1-9) to assess for adverse events, assess the participant's pain, obtain their satisfaction with their dressing and aesthetic appearance of the incision.

Research staff will call subjects on approximately postoperative day 30 (±2 days). They will ask the patient standardized questions regarding wound complications, patient satisfaction, pain and aesthetic appearance. If the patient reports a hospital, clinic, or ER visit not associated with the study centers, the staff will obtain the name of the medical facility and request the records.

The EQ-5D-3L quality of life questionnaire will be administered at the 30-day call.

Medical records from postpartum clinic visits as well as records of unscheduled visits (to any hospital clinic or ER) will be sought to ascertain study outcomes.

At the time of the subject's standard of care postpartum appointment about 4-6 weeks after inpatient hospital discharge research staff will collect information on outcomes, pain and patient satisfaction. If the patient does not attend the clinical postpartum visit, the study staff will contact the subject by phone to collect the data.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Scheduled/non-labor or unscheduled/labor cesarean delivery
2. Gestational age greater than or equal to 23 weeks

Exclusion Criteria:

1. Unwilling or unable to provide consent
2. Non-availability for postoperative follow-up
3. Contraindication to NPWT

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Invia Motion Arm	Device: Invia Motion; Invia Motion NPWT system at cesarean delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores: Discharge Time Frame	Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain	At post-operative day 3 (+/- 1 days)
Pain Scores: Scores Postpartum Day 30	Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain	At postoperative day 30 (+/- 2 days)
Patient Satisfaction: Scores Discharge Time Frame	Patient satisfaction scores (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction	At postoperative day 3 (+/- 1 days)
Patient Satisfaction: Scores Postpartum Day 30	Patient satisfaction scores (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction	At postoperative day 30 (+/- 2 days)
Patient Satisfaction With Aesthetic Appearance: Scale	Patient satisfaction with aesthetic appearance (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction	At postoperative day 30 (+/- 2 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Infection; Proportion of Incidence	Composite wound complication; wound infection as diagnosed by treating clinician	4-6 Weeks Postpartum
Wound Separation; Proportion of Incidence	Composite wound complication; wound separation as diagnosed by treating clinician	4-6 Weeks Postpartum
Seroma; Proportion of Incidence	Composite wound complication; seroma as diagnosed by treating clinician	4-6 Weeks Postpartum
Antibiotics Prescribed for Presumed SSI; Proportion of Incidence	Composite wound complication; antibiotics prescribed by treating clinician for wound-related infection	4-6 Weeks Postpartum
Skin Blistering; Safety Outcomes	Safety outcome; proportion of incidence of skin blistering around surgical wound	4-6 Weeks Postpartum
Allergic Reaction; Safety Outcomes	Safety outcome; proportion of allergic reaction to wound dressing	4-6 Weeks Postpartum
Wound Bleeding; Safety Outcomes	Safety outcome; proportion of wound bleeding	4-6 Weeks Postpartum

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Medela AG
• Investigators: Principal Investigator: Methodius Tuuli, MD, MPH, Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HC#1902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No