Trial Outcomes & Findings for The Invia Motion at Cesarean Study (NCT NCT04365452)
NCT ID: NCT04365452
Last Updated: 2023-05-11
Results Overview
Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain
COMPLETED
PHASE4
20 participants
At post-operative day 3 (+/- 1 days)
2023-05-11
Participant Flow
All patient undergoing cesarean delivery who consented were included
Participant milestones
| Measure |
Invia Motion Arm
Invia Motion: Invia Motion NPWT system at cesarean delivery
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Invia Motion at Cesarean Study
Baseline characteristics by cohort
| Measure |
Invia Motion Arm
n=20 Participants
Invia Motion: Invia Motion NPWT system at cesarean delivery
|
|---|---|
|
Age, Continuous
|
25 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At post-operative day 3 (+/- 1 days)Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain
Outcome measures
| Measure |
Invia Motion Arm
n=20 Participants
Invia Motion: Invia Motion NPWT system at cesarean delivery
|
|---|---|
|
Pain Scores: Discharge Time Frame
|
2.5 score on a scale
Interval 1.0 to 5.0
|
PRIMARY outcome
Timeframe: At postoperative day 30 (+/- 2 days)Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain
Outcome measures
| Measure |
Invia Motion Arm
n=20 Participants
Invia Motion: Invia Motion NPWT system at cesarean delivery
|
|---|---|
|
Pain Scores: Scores Postpartum Day 30
|
0 score on a scale
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: At postoperative day 3 (+/- 1 days)Patient satisfaction scores (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction
Outcome measures
| Measure |
Invia Motion Arm
n=20 Participants
Invia Motion: Invia Motion NPWT system at cesarean delivery
|
|---|---|
|
Patient Satisfaction: Scores Discharge Time Frame
|
10 score on a scale
Interval 8.5 to 10.0
|
PRIMARY outcome
Timeframe: At postoperative day 30 (+/- 2 days)Patient satisfaction scores (satisfaction score on scale of 0 - 10); 0 represents no satisfaction, 10 represents highest satisfaction
Outcome measures
| Measure |
Invia Motion Arm
n=20 Participants
Invia Motion: Invia Motion NPWT system at cesarean delivery
|
|---|---|
|
Patient Satisfaction: Scores Postpartum Day 30
|
10 score on a scale
Interval 10.0 to 10.0
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Invia Motion Arm
n=20 Participants
Invia Motion: Invia Motion NPWT system at cesarean delivery
|
|---|---|
|
Patient Satisfaction With Aesthetic Appearance: Scale
|
10 score on a scale
Interval 10.0 to 10.0
|
SECONDARY outcome
Timeframe: 4-6 Weeks PostpartumComposite wound complication; wound infection as diagnosed by treating clinician
Outcome measures
| Measure |
Invia Motion Arm
n=20 Participants
Invia Motion: Invia Motion NPWT system at cesarean delivery
|
|---|---|
|
Wound Infection; Proportion of Incidence
|
0 Participants
|
SECONDARY outcome
Timeframe: 4-6 Weeks PostpartumComposite wound complication; wound separation as diagnosed by treating clinician
Outcome measures
| Measure |
Invia Motion Arm
n=20 Participants
Invia Motion: Invia Motion NPWT system at cesarean delivery
|
|---|---|
|
Wound Separation; Proportion of Incidence
|
0 Participants
|
SECONDARY outcome
Timeframe: 4-6 Weeks PostpartumComposite wound complication; seroma as diagnosed by treating clinician
Outcome measures
| Measure |
Invia Motion Arm
n=20 Participants
Invia Motion: Invia Motion NPWT system at cesarean delivery
|
|---|---|
|
Seroma; Proportion of Incidence
|
0 Participants
|
SECONDARY outcome
Timeframe: 4-6 Weeks PostpartumComposite wound complication; antibiotics prescribed by treating clinician for wound-related infection
Outcome measures
| Measure |
Invia Motion Arm
n=20 Participants
Invia Motion: Invia Motion NPWT system at cesarean delivery
|
|---|---|
|
Antibiotics Prescribed for Presumed SSI; Proportion of Incidence
|
0 Participants
|
SECONDARY outcome
Timeframe: 4-6 Weeks PostpartumSafety outcome; proportion of incidence of skin blistering around surgical wound
Outcome measures
| Measure |
Invia Motion Arm
n=20 Participants
Invia Motion: Invia Motion NPWT system at cesarean delivery
|
|---|---|
|
Skin Blistering; Safety Outcomes
|
0 Participants
|
SECONDARY outcome
Timeframe: 4-6 Weeks PostpartumSafety outcome; proportion of allergic reaction to wound dressing
Outcome measures
| Measure |
Invia Motion Arm
n=20 Participants
Invia Motion: Invia Motion NPWT system at cesarean delivery
|
|---|---|
|
Allergic Reaction; Safety Outcomes
|
0 Participants
|
SECONDARY outcome
Timeframe: 4-6 Weeks PostpartumSafety outcome; proportion of wound bleeding
Outcome measures
| Measure |
Invia Motion Arm
n=20 Participants
Invia Motion: Invia Motion NPWT system at cesarean delivery
|
|---|---|
|
Wound Bleeding; Safety Outcomes
|
0 Participants
|
Adverse Events
Invia Motion Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Theresa Joyce, Quality Improvement Consultant, Research Complaince
Indiana Univiersity
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place