Negative Pressure Wound TherapyPhase 4NCT04365452
The Invia Motion at Cesarean Study
A Phase 4 study testing Invia Motion in people with Negative Pressure Wound Therapy and Cesarean Section; Infection, run by Indiana University at 1 site in United States.
Trial summary
To assess patient centered outcomes of the Medela INVIA Motion prophylactic NPWT system at cesarean delivery. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Negative Pressure Wound Therapy, Cesarean Section; Infection
- What is being tested?
- Invia Motion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2020to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Scheduled/non-labor or unscheduled/labor cesarean delivery
- Gestational age greater than or equal to 23 weeks
Who cannot join
- Unwilling or unable to provide consent
- Non-availability for postoperative follow-up
- Contraindication to NPWT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Being tested
- Invia Motion
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invia MotionDevice
Invia Motion NPWT system at cesarean delivery
| Study group | Role | What they receive |
|---|---|---|
| Invia Motion Arm | Experimental | Not described Receives: Device: Invia Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores: Discharge Time Frame
Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At postoperative day 30 (+/- 2 days)
Secondary outcomes (7)
Wound Infection; Proportion of Incidence
Composite wound complication; wound infection as diagnosed by treating clinician
Measured: 4-6 Weeks Postpartum
Wound Separation; Proportion of Incidence
Composite wound complication; wound separation as diagnosed by treating clinician
Measured: 4-6 Weeks Postpartum
Seroma; Proportion of Incidence
Composite wound complication; seroma as diagnosed by treating clinician
Measured: 4-6 Weeks Postpartum
Antibiotics Prescribed for Presumed SSI; Proportion of Incidence
Composite wound complication; antibiotics prescribed by treating clinician for wound-related infection
Measured: 4-6 Weeks Postpartum
Skin Blistering; Safety Outcomes
Safety outcome; proportion of incidence of skin blistering around surgical wound
Measured: 4-6 Weeks Postpartum
Allergic Reaction; Safety Outcomes
Safety outcome; proportion of allergic reaction to wound dressing
Measured: 4-6 Weeks Postpartum
Wound Bleeding; Safety Outcomes
Safety outcome; proportion of wound bleeding
Measured: 4-6 Weeks Postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start10 Mar 2020
- Primary completion31 Aug 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Negative Pressure Wound TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Medela Invia pump
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Medela AG
- Responsible party
- Principal investigator, David Haas, Indiana University
- Investigators
- Methodius Tuuli, MD, MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365452
- Sponsor's protocol ID
- HC#1902
- Status last verified
- May 2023
- First submitted
- 5 Mar 2020
- Last updated
- 11 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medela INVIA Motion NPWT System for Prophylactic Use on Surgical Incision After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT04365452
- Acronym / sponsor ID
- HC#1902
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Medela AG
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Posted 11 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess patient centered outcomes of the Medela INVIA Motion prophylactic NPWT system at cesarean delivery.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Medela Invia pump
| Arm | Type | Receives |
|---|---|---|
| Invia Motion Arm | Experimental | Device: Invia Motion |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled/non-labor or unscheduled/labor cesarean delivery
- Gestational age greater than or equal to 23 weeks
Key exclusion criteria (3 listed)
- Unwilling or unable to provide consent
- Non-availability for postoperative follow-up
- Contraindication to NPWT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invia MotionInvia Motion NPWT system at cesarean delivery | Device | Invia Motion Arm |
Primary outcome
Pain Scores: Discharge Time Frame
Time frame: At post-operative day 3 (+/- 1 days)
Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain
Pain Scores: Scores Postpartum Day 30
Time frame: At postoperative day 30 (+/- 2 days)
Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain
Patient Satisfaction: Scores Discharge Time Frame
Time frame: At postoperative day 3 (+/- 1 days)
Patient satisfaction scores (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction
Patient Satisfaction: Scores Postpartum Day 30
Time frame: At postoperative day 30 (+/- 2 days)
Patient satisfaction scores (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction
Patient Satisfaction With Aesthetic Appearance: Scale
Time frame: At postoperative day 30 (+/- 2 days)
Patient satisfaction with aesthetic appearance (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction
7 secondary outcomes
Wound Infection; Proportion of Incidence
Time frame: 4-6 Weeks Postpartum
Wound Separation; Proportion of Incidence
Time frame: 4-6 Weeks Postpartum
Seroma; Proportion of Incidence
Time frame: 4-6 Weeks Postpartum
Antibiotics Prescribed for Presumed SSI; Proportion of Incidence
Time frame: 4-6 Weeks Postpartum
Skin Blistering; Safety Outcomes
Time frame: 4-6 Weeks Postpartum
Allergic Reaction; Safety Outcomes
Time frame: 4-6 Weeks Postpartum
Wound Bleeding; Safety Outcomes
Time frame: 4-6 Weeks Postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Methodius Tuuli, MD, MPH principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Invia Motion in people with Negative Pressure Wound Therapy and Cesarean Section; Infection, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores: Discharge Time Frame (time frame: At post-operative day 3 (+/- 1 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.