The Invia Motion at Cesarean Study

Cesarean Section; Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04365452
• Other study ID #: HC#1902
• Status: Completed
• Phase: Phase 4
• Start date: March 10, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section; Infection
• Negative Pressure Wound Therapy

Intervention

Device:
• Invia Motion
Invia Motion NPWT system at cesarean delivery

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Medela AG

Country where clinical trial is conducted

United States, 

Outcome

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