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Amniotic Fluid Spray for Cesarean Wound Healing
N/A
Waitlist Available
Led By Jennifer Gilner, MD
Research Sponsored by Recibio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 and 6 weeks
Awards & highlights
Study Summary
This trial will test whether amniotic fluid can be used as a spray to help heal c-section wounds.
Who is the study for?
This trial is for pregnant women over 18, expecting one baby, and planning a cesarean delivery. They must speak English, be at least weeks into their pregnancy, can consent themselves, and commit to the full study period including follow-ups.Check my eligibility
What is being tested?
The study tests if collecting amniotic fluid during cesarean delivery and then spraying it on the wound layers helps with healing. The process involves immediate collection and application of the patient's own fluid.See study design
What are the potential side effects?
Since this trial uses autologous (the patient's own) amniotic fluid applied topically, side effects are expected to be minimal but may include potential allergic reactions or infection at the site of application.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at time of delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Collection and reapplication of autologous amniotic fluid
Secondary outcome measures
Assessment of the Cesarean Wound
Cesarean Wound Complication
Pain Medication Use
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Collection and reapplication of amniotic fluid.
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Who is running the clinical trial?
Recibio, Inc.Lead Sponsor
Duke UniversityOTHER
2,358 Previous Clinical Trials
3,420,049 Total Patients Enrolled
Jennifer Gilner, MDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
1,000 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are participating in this clinical trial?
"Affirmative, according to clinicaltrials.gov this trial is in the process of recruiting patients and was posted on October 1st 2020 with a most recent update occurring August 30th 2022. The study plans to enrol 20 individuals from one particular medical centre."
Answered by AI
Are there any unfilled slots left in this clinical research?
"Indeed, the information hosted on clinicaltrials.gov affirms that this research project is in need of volunteers; it was first made available to the public on October 1st 2020 and has been recently updated as of August 30th 2022. This medical trial requires twenty participants from one site."
Answered by AI
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