The Collection and Application of Autologous Amniotic Fluid At Cesarean Delivery Closure.
NCT04359472 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-12-13
Summary
The purpose of this study is to determine the feasibility of collecting amniotic fluid at delivery that will be immediately processed and then applied as a spray to the various layers of cesarean wound closure.
Conditions
- Pregnancy Related
- Cesarean Wound Disruption
- Cesarean Section; Infection
Interventions
- DEVICE
-
Application of Autologous Amniotic Fluid
Collection and reapplication of amniotic fluid at wound layers during a cesarean section.
Sponsors & Collaborators
- collaborator OTHER
-
Recibio, Inc.
lead INDUSTRY
Principal Investigators
-
Jennifer Gilner, MD · Duke University
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-10-01
- Primary Completion
- 2023-09-01
- Completion
- 2024-09-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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