The Invia Motion at Cesarean Study

NCT04365452 | Completed Phase 4 Results FDA Device

• 1 other identifier: HC#1902
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Negative Pressure Wound Therapy; Cesarean Section; Infection

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Wound Infection; Proportion of Incidence

  4-6 Weeks Postpartum

• Wound Separation; Proportion of Incidence

  4-6 Weeks Postpartum

• Seroma; Proportion of Incidence

  4-6 Weeks Postpartum

• Antibiotics Prescribed for Presumed SSI; Proportion of Incidence

  4-6 Weeks Postpartum

• Skin Blistering; Safety Outcomes

  4-6 Weeks Postpartum

Study Arms (1)

Invia Motion Arm

EXPERIMENTAL

Device: Invia Motion

Interventions

Invia Motion DEVICE

Invia Motion NPWT system at cesarean delivery

Invia Motion Arm

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unwilling or unable to provide consent
• Non-availability for postoperative follow-up
• Contraindication to NPWT

Sponsors & Collaborators

• Indiana University: lead
• Medela AG: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Infections

Results Point of Contact

• Title: Theresa Joyce, Quality Improvement Consultant, Research Complaince
• Organization: Indiana Univiersity

tajoyce@iu.edu

3172921882

Study Officials

• Methodius Tuuli, MD, MPH

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Model Details: Medela Invia pump

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: April 28, 2020
• Study Start: March 10, 2020
• Primary Completion: August 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 11, 2023
• Results First Posted: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)