Cesarean Section; Infection Clinical Trial
Official title:
Medela INVIA Motion NPWT System for Prophylactic Use on Surgical Incision After Cesarean Delivery
To assess patient centered outcomes of the Medela INVIA Motion prophylactic NPWT system at cesarean delivery.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03960970 -
Two-drug Antibiotic Prophylaxis in Scheduled Cesarean Deliveries
|
Phase 2 | |
Recruiting |
NCT05920122 -
Aqueous vs Alcohol Chlorhexidine Skin Preparation for Prevention of Cesarean Section Wound Infections
|
Phase 4 | |
Active, not recruiting |
NCT04359472 -
The Collection and Application of Autologous Amniotic Fluid at Cesarean Delivery Closure.
|
N/A | |
Completed |
NCT03640507 -
Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline
|
Phase 2/Phase 3 | |
Completed |
NCT05330650 -
Evaluation of Triclosan Coated Suture in Obstetrical Surgery
|
Phase 4 | |
Completed |
NCT04587960 -
Delayed Primary Closure of Skin in Emergency Caesarean Section
|
N/A | |
Completed |
NCT03838965 -
The Effects of Labor Stages and Interventions on Hemodynamic Measures During & After Childbirth With Noninvasive Sensors
|
N/A | |
Not yet recruiting |
NCT06339203 -
Intraoperative Wound Irrigation in Cesarean Section
|
N/A | |
Completed |
NCT05807633 -
Performance of Novosyn® in Patients Undergoing Uterus Closure in Cesarean Section
|
||
Not yet recruiting |
NCT03672214 -
Caesarean Delivery With or Without an Indwelling Bladder Catheter
|
N/A | |
Recruiting |
NCT03500055 -
Abdominal Closure Bundle to Reduce Surgical Site Infection in Patients Undergoing C-sections. Cesarean Section Lead to Reduction in Surgical Site Infection? - A Randomized Controlled Trial
|
N/A | |
Recruiting |
NCT03386240 -
Antibacterial-coated Sutures at Time of Cesarean
|
Phase 4 | |
Completed |
NCT03284749 -
Effect of Copper on the Healing of Obstetric Wounds
|
N/A | |
Active, not recruiting |
NCT06048692 -
Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections
|
Phase 3 | |
Completed |
NCT06119113 -
Wound Infection Due to Suture Material in Caesarean Skin Incision and Evaluation of Cosmetic Results
|
N/A | |
Terminated |
NCT03479931 -
Caesarean Delivery With or Without an Indwelling Bladder Catheter. A Randomised Trial.
|
N/A | |
Recruiting |
NCT04476212 -
Prophylaxis of Surgical Wound Infection With Topical Antibiotics
|
N/A | |
Completed |
NCT03536832 -
Subcuticular Skin Closure at Cesarean Delivery
|
N/A |