Clinical trial NCT04365452: The Invia Motion at Cesarean Study
Official title: Medela INVIA Motion NPWT System for Prophylactic Use on Surgical Incision After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Negative Pressure Wound Therapy
Cesarean Section; Infection
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Medela AG
First posted: 2020-04-28
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Medela Invia pump
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Scheduled/non-labor or unscheduled/labor cesarean delivery
2. Gestational age greater than or equal to 23 weeks

Exclusion Criteria:

1. Unwilling or unable to provide consent
2. Non-availability for postoperative follow-up
3. Contraindication to NPWT

Primary outcomes:
measure: Pain Scores: Discharge Time Frame
timeFrame: At post-operative day 3 (+/- 1 days)
measure: Pain Scores: Scores Postpartum Day 30
timeFrame: At postoperative day 30 (+/- 2 days)
measure: Patient Satisfaction: Scores Discharge Time Frame
timeFrame: At postoperative day 3 (+/- 1 days)
measure: Patient Satisfaction: Scores Postpartum Day 30
timeFrame: At postoperative day 30 (+/- 2 days)
measure: Patient Satisfaction With Aesthetic Appearance: Scale
timeFrame: At postoperative day 30 (+/- 2 days)
Secondary outcomes:
measure: Wound Infection; Proportion of Incidence
timeFrame: 4-6 Weeks Postpartum
measure: Wound Separation; Proportion of Incidence
timeFrame: 4-6 Weeks Postpartum
measure: Seroma; Proportion of Incidence
timeFrame: 4-6 Weeks Postpartum
measure: Antibiotics Prescribed for Presumed SSI; Proportion of Incidence
timeFrame: 4-6 Weeks Postpartum
measure: Skin Blistering; Safety Outcomes
timeFrame: 4-6 Weeks Postpartum
measure: Allergic Reaction; Safety Outcomes
timeFrame: 4-6 Weeks Postpartum
measure: Wound Bleeding; Safety Outcomes
timeFrame: 4-6 Weeks Postpartum
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Methodius Tuuli, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: