The Invia Motion at Cesarean Study

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

Detailed Description
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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.

Official Title
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Medela INVIA Motion NPWT System for Prophylactic Use on Surgical Incision After Cesarean Delivery

Conditions
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Negative Pressure Wound Therapy, Cesarean Section; Infection

Intervention / Treatment
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* Device: Invia Motion


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Medela Invia pump
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Invia Motion Arm<br> | Device: Invia Motion<br>* Invia Motion NPWT system at cesarean delivery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores: Discharge Time Frame | Pain scores (pain score on scale of 0 - 10); 0 represents no pain, 10 represents highest pain | 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 | 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 | 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 | 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 | At postoperative day 30 (+/- 2 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Infection; Proportion of Incidence | Composite wound complication; wound infection as diagnosed by treating clinician | 4-6 Weeks Postpartum | 
| Wound Separation; Proportion of Incidence | Composite wound complication; wound separation as diagnosed by treating clinician | 4-6 Weeks Postpartum | 
| Seroma; Proportion of Incidence | Composite wound complication; seroma as diagnosed by treating clinician | 4-6 Weeks Postpartum | 
| Antibiotics Prescribed for Presumed SSI; Proportion of Incidence | Composite wound complication; antibiotics prescribed by treating clinician for wound-related infection | 4-6 Weeks Postpartum | 
| Skin Blistering; Safety Outcomes | Safety outcome; proportion of incidence of skin blistering around surgical wound | 4-6 Weeks Postpartum | 
| Allergic Reaction; Safety Outcomes | Safety outcome; proportion of allergic reaction to wound dressing | 4-6 Weeks Postpartum | 
| Wound Bleeding; Safety Outcomes | Safety outcome; proportion of wound bleeding | 4-6 Weeks Postpartum |