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
To assess patient centered outcomes of the Medela INVIA Motion prophylactic NPWT system at cesarean delivery.
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.
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.
Exclusion Criteria:
Device: Invia Motion
Invia Motion NPWT system at cesarean delivery
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)
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)
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)
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)
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)
Wound Infection; Proportion of Incidence
Composite wound complication; wound infection as diagnosed by treating clinician
Time frame: 4-6 Weeks Postpartum
Wound Separation; Proportion of Incidence
Composite wound complication; wound separation as diagnosed by treating clinician
Time frame: 4-6 Weeks Postpartum
Seroma; Proportion of Incidence
Composite wound complication; seroma as diagnosed by treating clinician
Time frame: 4-6 Weeks Postpartum
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
Skin Blistering; Safety Outcomes
Safety outcome; proportion of incidence of skin blistering around surgical wound
Time frame: 4-6 Weeks Postpartum
Allergic Reaction; Safety Outcomes
Safety outcome; proportion of allergic reaction to wound dressing
Time frame: 4-6 Weeks Postpartum
Wound Bleeding; Safety Outcomes
Safety outcome; proportion of wound bleeding
Time frame: 4-6 Weeks Postpartum
| Milestone | Invia Motion Arm |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain
| score on a scale | Invia Motion Arm |
|---|---|
| Pain Scores: Discharge Time Frame | 2.5 (1 to 5) |
Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain
| score on a scale | Invia Motion Arm |
|---|---|
| Pain Scores: Scores Postpartum Day 30 | 0 (0 to 1) |
Patient satisfaction scores (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction
| score on a scale | Invia Motion Arm |
|---|---|
| Patient Satisfaction: Scores Discharge Time Frame | 10 (8.5 to 10) |
Patient satisfaction scores (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction
| score on a scale | Invia Motion Arm |
|---|---|
| Patient Satisfaction: Scores Postpartum Day 30 | 10 (10 to 10) |
Patient satisfaction with aesthetic appearance (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction
| score on a scale | Invia Motion Arm |
|---|---|
| Patient Satisfaction With Aesthetic Appearance: Scale | 10 (10 to 10) |
Composite wound complication; wound infection as diagnosed by treating clinician
| Participants | Invia Motion Arm |
|---|---|
| Wound Infection; Proportion of Incidence | 0 |
Composite wound complication; wound separation as diagnosed by treating clinician
| Participants | Invia Motion Arm |
|---|---|
| Wound Separation; Proportion of Incidence | 0 |
Composite wound complication; seroma as diagnosed by treating clinician
| Participants | Invia Motion Arm |
|---|---|
| Seroma; Proportion of Incidence | 0 |
Composite wound complication; antibiotics prescribed by treating clinician for wound-related infection
| Participants | Invia Motion Arm |
|---|---|
| Antibiotics Prescribed for Presumed SSI; Proportion of Incidence | 0 |
Safety outcome; proportion of incidence of skin blistering around surgical wound
| Participants | Invia Motion Arm |
|---|---|
| Skin Blistering; Safety Outcomes | 0 |
Safety outcome; proportion of allergic reaction to wound dressing
| Participants | Invia Motion Arm |
|---|---|
| Allergic Reaction; Safety Outcomes | 0 |
Safety outcome; proportion of wound bleeding
| Participants | Invia Motion Arm |
|---|---|
| Wound Bleeding; Safety Outcomes | 0 |
Collected over 4 - 6 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Invia Motion Arm | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Invia Motion Arm |
|---|---|
| Median | 25 (22 to 28) |
| Sex: Female, Male(Participants) | Invia Motion Arm |
|---|---|
| Female | 20 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Invia Motion Arm |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 19 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Invia Motion Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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