CClinicalTrials.gg
CompletedNCT04365452Updated May 11, 2023Results posted

The Invia Motion at Cesarean Study

A Phase 4 interventional study of Invia Motion in Negative Pressure Wound Therapy and Cesarean Section; Infection, sponsored by Indiana University. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2023-05-11.

Sponsored by Indiana University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Negative Pressure Wound Therapy
  • Cesarean Section; Infection
03

In context

Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Unwilling or unable to provide consent
  2. Non-availability for postoperative follow-up
  3. Contraindication to NPWT
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Invia Motion Arm

    Device: Invia Motion

Interventions

  • DeviceInvia Motion

    Invia Motion NPWT system at cesarean delivery

06

What researchers measure

Primary outcomes

  1. Pain Scores: Discharge Time Frame

    Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain

    Time frame: At post-operative day 3 (+/- 1 days)

  2. Pain Scores: Scores Postpartum Day 30

    Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain

    Time frame: At postoperative day 30 (+/- 2 days)

  3. Patient Satisfaction: Scores Discharge Time Frame

    Patient satisfaction scores (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction

    Time frame: At postoperative day 3 (+/- 1 days)

  4. Patient Satisfaction: Scores Postpartum Day 30

    Patient satisfaction scores (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction

    Time frame: At postoperative day 30 (+/- 2 days)

  5. 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

    Time frame: At postoperative day 30 (+/- 2 days)

Secondary outcomes

  1. Wound Infection; Proportion of Incidence

    Composite wound complication; wound infection as diagnosed by treating clinician

    Time frame: 4-6 Weeks Postpartum

  2. Wound Separation; Proportion of Incidence

    Composite wound complication; wound separation as diagnosed by treating clinician

    Time frame: 4-6 Weeks Postpartum

  3. Seroma; Proportion of Incidence

    Composite wound complication; seroma as diagnosed by treating clinician

    Time frame: 4-6 Weeks Postpartum

  4. Antibiotics Prescribed for Presumed SSI; Proportion of Incidence

    Composite wound complication; antibiotics prescribed by treating clinician for wound-related infection

    Time frame: 4-6 Weeks Postpartum

  5. Skin Blistering; Safety Outcomes

    Safety outcome; proportion of incidence of skin blistering around surgical wound

    Time frame: 4-6 Weeks Postpartum

  6. Allergic Reaction; Safety Outcomes

    Safety outcome; proportion of allergic reaction to wound dressing

    Time frame: 4-6 Weeks Postpartum

  7. Wound Bleeding; Safety Outcomes

    Safety outcome; proportion of wound bleeding

    Time frame: 4-6 Weeks Postpartum

07

Results

Posted May 11, 2023

Participant flow

Participant flow — Overall Study
MilestoneInvia Motion Arm
Started20
Completed20
Not completed0

Outcome measures

PrimaryPain Scores: Discharge Time Frame

Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain

Time frame:
At post-operative day 3 (+/- 1 days)
Reported as:
Median · score on a scale
Pain Scores: Discharge Time Frame
score on a scaleInvia Motion Arm
Pain Scores: Discharge Time Frame2.5 (1 to 5)
PrimaryPain Scores: Scores Postpartum Day 30

Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain

Time frame:
At postoperative day 30 (+/- 2 days)
Reported as:
Median · score on a scale
Pain Scores: Scores Postpartum Day 30
score on a scaleInvia Motion Arm
Pain Scores: Scores Postpartum Day 300 (0 to 1)
PrimaryPatient Satisfaction: Scores Discharge Time Frame

Patient satisfaction scores (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction

Time frame:
At postoperative day 3 (+/- 1 days)
Reported as:
Median · score on a scale
Patient Satisfaction: Scores Discharge Time Frame
score on a scaleInvia Motion Arm
Patient Satisfaction: Scores Discharge Time Frame10 (8.5 to 10)
PrimaryPatient Satisfaction: Scores Postpartum Day 30

Patient satisfaction scores (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction

Time frame:
At postoperative day 30 (+/- 2 days)
Reported as:
Median · score on a scale
Patient Satisfaction: Scores Postpartum Day 30
score on a scaleInvia Motion Arm
Patient Satisfaction: Scores Postpartum Day 3010 (10 to 10)
PrimaryPatient 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

Time frame:
At postoperative day 30 (+/- 2 days)
Reported as:
Median · score on a scale
Patient Satisfaction With Aesthetic Appearance: Scale
score on a scaleInvia Motion Arm
Patient Satisfaction With Aesthetic Appearance: Scale10 (10 to 10)
SecondaryWound Infection; Proportion of Incidence

Composite wound complication; wound infection as diagnosed by treating clinician

Time frame:
4-6 Weeks Postpartum
Reported as:
Count of participants · Participants
Wound Infection; Proportion of Incidence
ParticipantsInvia Motion Arm
Wound Infection; Proportion of Incidence0
SecondaryWound Separation; Proportion of Incidence

Composite wound complication; wound separation as diagnosed by treating clinician

Time frame:
4-6 Weeks Postpartum
Reported as:
Count of participants · Participants
Wound Separation; Proportion of Incidence
ParticipantsInvia Motion Arm
Wound Separation; Proportion of Incidence0
SecondarySeroma; Proportion of Incidence

Composite wound complication; seroma as diagnosed by treating clinician

Time frame:
4-6 Weeks Postpartum
Reported as:
Count of participants · Participants
Seroma; Proportion of Incidence
ParticipantsInvia Motion Arm
Seroma; Proportion of Incidence0
SecondaryAntibiotics Prescribed for Presumed SSI; Proportion of Incidence

Composite wound complication; antibiotics prescribed by treating clinician for wound-related infection

Time frame:
4-6 Weeks Postpartum
Reported as:
Count of participants · Participants
Antibiotics Prescribed for Presumed SSI; Proportion of Incidence
ParticipantsInvia Motion Arm
Antibiotics Prescribed for Presumed SSI; Proportion of Incidence0
SecondarySkin Blistering; Safety Outcomes

Safety outcome; proportion of incidence of skin blistering around surgical wound

Time frame:
4-6 Weeks Postpartum
Reported as:
Count of participants · Participants
Skin Blistering; Safety Outcomes
ParticipantsInvia Motion Arm
Skin Blistering; Safety Outcomes0
SecondaryAllergic Reaction; Safety Outcomes

Safety outcome; proportion of allergic reaction to wound dressing

Time frame:
4-6 Weeks Postpartum
Reported as:
Count of participants · Participants
Allergic Reaction; Safety Outcomes
ParticipantsInvia Motion Arm
Allergic Reaction; Safety Outcomes0
SecondaryWound Bleeding; Safety Outcomes

Safety outcome; proportion of wound bleeding

Time frame:
4-6 Weeks Postpartum
Reported as:
Count of participants · Participants
Wound Bleeding; Safety Outcomes
ParticipantsInvia Motion Arm
Wound Bleeding; Safety Outcomes0

Adverse events

Collected over 4 - 6 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Invia Motion Arm0/20 (0%)0/20 (0%)0/20 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Invia Motion Arm
Median25 (22 to 28)
Sex: Female, Male
Sex: Female, Male(Participants)Invia Motion Arm
Female20
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Invia Motion Arm
Hispanic or Latino1
Not Hispanic or Latino19
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Invia Motion Arm
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American6
White14
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Indiana University
    Indianapolis, Indiana 46202, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 15, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04365452
Lead sponsor
Indiana University
Collaborators
Medela AG
Responsible party
David Haas (Professor of Obstetrics and Gynecology, Indiana University School of Medicine) — Principal investigator
First posted
Apr 28, 2020
Start date
Mar 10, 2020
Primary completion
Aug 31, 2020
Completion
Dec 31, 2020
Results posted
May 11, 2023
Last update
May 11, 2023

Study contacts

Methodius Tuuli, MD, MPH
principal investigator · Indiana University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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