Phase 4
N=20
The Invia Motion at Cesarean Study
Negative Pressure Wound Therapy · Cesarean Section; Infection
Bottom Line
View on ClinicalTrials.gov: NCT04365452 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Pain Scores: Discharge Time Frame — 2.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Invia Motion (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Indiana University
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Scores: Discharge Time Frame |
2.5 | — |
| PRIMARY Pain Scores: Scores Postpartum Day 30 |
— | — |
| PRIMARY Patient Satisfaction: Scores Discharge Time Frame |
10 | — |
| PRIMARY Patient Satisfaction: Scores Postpartum Day 30 |
10 | — |
| PRIMARY Patient Satisfaction With Aesthetic Appearance: Scale |
10 | — |
| SECONDARY Wound Infection; Proportion of Incidence |
— | — |
| SECONDARY Wound Separation; Proportion of Incidence |
— | — |
| SECONDARY Seroma; Proportion of Incidence |
— | — |
| SECONDARY Antibiotics Prescribed for Presumed SSI; Proportion of Incidence |
— | — |
| SECONDARY Skin Blistering; Safety Outcomes |
— | — |
| SECONDARY Allergic Reaction; Safety Outcomes |
— | — |
| SECONDARY Wound Bleeding; Safety Outcomes |
— | — |
Summary
To assess patient centered outcomes of the Medela INVIA Motion prophylactic NPWT system at cesarean delivery.
Eligibility Criteria
Inclusion Criteria
- Scheduled/non-labor or unscheduled/labor cesarean delivery
- Gestational age greater than or equal to 23 weeks
Exclusion Criteria
- Unwilling or unable to provide consent
- Non-availability for postoperative follow-up
- Contraindication to NPWT
Data sourced from ClinicalTrials.gov (NCT04365452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.