The Invia Motion at Cesarean Study

Indiana University

Status and phase

Completed

Phase 4

Conditions

Negative Pressure Wound Therapy

Cesarean Section; Infection

Treatments

Device: Invia Motion

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04365452

HC#1902

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria