CompletedNot Applicable

the Effects of Platelet-Rich Plasma on Postoperative Complications After Meningomyelocele

Turkey (Türkiye)40 participantsStarted 2022-01-15

Plain-language summary

Introduction: Meningomyelocele is a common congenital neural tube defect. To reduce complications, early surgery and a multidisciplinary approach is needed. In this study, the investigators administered platelet-rich plasma (PRP) to newborns with meningomyelocele following corrective surgery to minimize cerebrospinal fluid (CSF) leakage and accelerate the healing of the immature pouch tissue. The investigators compared these with a control group that did not receive PRP. Patients and Methods: Of the 40 newborns who were operated on with the diagnosis of meningomyelocele, 20 patients received PRP after surgical repair, and 20 were followed up without PRP. In the PRP group, 10 of the 20 patients underwent primary defect repair, the other 10 underwent flap repair. In the group that did not receive PRP, primary closure was performed in 14 patients and flap closure in six.

Who can participate

Age range

1 Day – 1 Month

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Newborn babies born with a meningomyelocele sac Exclusion Criteria: * Newborn babies without a meningomyelocele sac

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Skin Dehicense Occurrence

Timeframe: up to first 14 days after the surgery

Partial Skin Necrosis Occurrence

Timeframe: up to first 14 days after the surgery

CSF Leak Occurrence

Timeframe: up to first 14 days after the surgery

Local Infection Occurrence

Timeframe: up to first 14 days after the surgery

Trial details

NCT IDNCT05711355

SponsorYuzuncu Yil University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-15

View on ClinicalTrials.gov More Meningomyelocele/Spina Bifida trials

Plain-language summary

Who can participate

Age range

1 Day – 1 Month

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Newborn babies born with a meningomyelocele sac Exclusion Criteria: * Newborn babies without a meningomyelocele sac