Meningomyelocele/Spina BifidaNCT05711355
the Effects of Platelet-Rich Plasma on Postoperative Complications After Meningomyelocele
A study testing Use of Platelet-Rich Plasma after meningomyelocele sac repair and meningomyelocele sac repair in people with Meningomyelocele/Spina Bifida, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Meningomyelocele/Spina Bifida
- What is being tested?
- Use of Platelet-Rich Plasma after meningomyelocele sac repair and meningomyelocele sac repair
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborn babies born with a meningomyelocele sac
Who cannot join
- Newborn babies without a meningomyelocele sac
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial of the Effects of Platelet-Rich Plasma on Postoperative Complications After Meningomyelocele Sac Repair
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.
Read the detailed description
Introduction Meningomyelocele (MMC), a form of spina bifida, is the most common congenital anomaly of the central nervous system. It occurs in the first four weeks of pregnancy when the neural tube of the embryo fails to close. Neural tube defects may result in hydrocephalus, hindbrain herniation, and exposure to toxins in the amniotic fluid, with potential morbidity and mortality (1). Both environmental and genetic factors contribute to the etiology of MMC. The risk of MMC is increasing in the events of maternal exposure to valproate, alcohol, carbamazepine, or isotretinoin; high fever; malnutrition, especially folate or B12 deficiency, diabetes mellitus, or obesity during pregnancy (2). About 1,427 babies are born with spina bifida each year in the United States (1 in 2,758 births). Lower socioeconomic status and older maternal age are associated with higher neural tube defect incidence. The recurrence rate in subsequent pregnancies is about 2% to 3% (3). More than 80% of babies born with MMC require a ventriculoperitoneal shunt for hydrocephalus decompression (4). In 39% of the patients, functional motor deficits are at the affected level or higher, and more than half of these have functional motor deficits two levels higher than the affected level (5). The purpose of early closure of MMC defects is to preserve neural tissue function and prevent sepsis.
Platelet-rich plasma (PRP) is an autologous concentration of human platelets obtained from venous blood through proper centrifugation. It contains several growth factors including platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), platelet-derived factor 4 (PF-4), insulin-like growth factor (IGF-1), and transforming growth factor-beta (TGF-b) (6). There are approximately 150-400 10³/mm³ platelets in the blood and PRP contains between four and seven times this amount (7). When whole blood is collected from a patient for the generation of PRP, an anticoagulant is added. This usually contains citrate and disrupts the coagulation cascade by binding to calcium ions (8). PRP is used in orthopedic indications, wound healing, facial rejuvenation, hair restoration, and other conditions in which tissue renewal is central. The use of PRP for surgical and non-surgical wounds is advantageous, especially in patients with poor wound healing, poor blood supply, and slow cell turnover, and in cases where rapid healing is required.
In this study, we assessed whether the administration of PRP during the MMC pouch repair procedure can improve infant outcomes. This was measured by its ability to reduce CSF leakage, meningitis, local infection, skin necrosis, wound dehiscence, and hydrocephalus, and to accelerate the healing of the underdeveloped pouch tissue. These outcomes were compared with those of an MMC control group who did not receive PRP during surgery.
Materials and Methods This study included 40 infants with a diagnosis of MMC who were operated on at our neurosurgery clinic between February 2020 and May 2021. PRP was administered to 20 of the patients and 20 were followed up without PRP. All babies were born at term and fed with breast milk. All infants in the study were followed up in the neonatal intensive care unit. The mean birth weight was 2990 grams. In the PRP group, 10 of the 20 patients underwent primary defect repair and 10 underwent flap repair. In the non-PRP group, 14 patients underwent primary closure and six underwent flap closure. All operations were performed under general anesthesia. Blood was taken from each patient and the platelets were separated by centrifugation at 3200 rpm for five min in a 2 cc whole blood centrifuge device. The plasma was separated with the buffy coat layer. During MMC sac repair, a neural plate was formed and the dura was then made using opposing flaps from the fascia. After hemostasis was achieved, the defect was repaired and PRP was applied from the wound edge. The prepared PRP was applied to the dura and pouch repair and under the skin flap wound line.
Descriptive statistics were expressed as means, standard deviations, medians, ranges, frequencies, and ratios. The distribution of variables was measured with the Kolmogorov-Smirnov test. Independent sample t-tests and Mann-Whitney U tests were used for the analysis of quantitative independent data. Chi-square tests were used in the analysis of qualitative independent data, and the Fischer test was used when the chi-square test conditions were not met. Analyses were performed using SPSS 27.0 software.
- Conditions
- Meningomyelocele/Spina Bifida
- Being tested
- Use of Platelet-Rich Plasma after meningomyelocele sac repair, meningomyelocele sac repair
- Keywords
- Meningomyelocele, myelomeningocele, neural tube defect, spina bifida, platelet-rich plasma, cerebrospinal fluid
- Medical subject headings
- Meningomyelocele, Spinal Dysraphism, Neural Tube Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Platelet-Rich Plasma after meningomyelocele sac repairProcedure or surgery
Wound healing with the use of Platelet-Rich Plasma after surgical meningomyelocele pouch repair
meningomyelocele sac repairProcedure or surgery
meningomyelocele sac repair without Platelet-Rich Plasma
| Study group | Role | What they receive |
|---|---|---|
| Use of Platelet-Rich Plasma after meningomyelocele sac repair | Active comparator | Paitents treated with platelet-rich plasma injection and treated with according to guidelines Receives: Procedure: Use of Platelet-Rich Plasma after meningomyelocele sac repair; Procedure: meningomyelocele sac repair |
| Control group of meningomyelocele sac repair | Active comparator | Paitents treated according to guidelines Receives: Procedure: meningomyelocele sac repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Dehicense Occurrence
Area of surgery has been examined daily for skin dehisence
Measured: up to first 14 days after the surgery
Partial Skin Necrosis Occurrence
Area of surgery has been examined daily for skin necrosis
Measured: up to first 14 days after the surgery
CSF Leak Occurrence
Area of surgery has been examined daily for CSF leakage
Measured: up to first 14 days after the surgery
Local Infection Occurrence
Area of surgery has been examined daily for wound infection
Measured: up to first 14 days after the surgery
Secondary outcomes (1)
Hydrocephalus Occurrence
Patients had examined as out-patients monthly for 6 months with head circumference documentation and with cranial MRIs
Measured: birth to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start15 Jan 2022
- Primary completion15 Nov 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Meningomyelocele/Spina BifidaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özkan Arabaci, Yuzuncu Yil University
- Investigators
- Mehmet Edip Akyol, Ass. Prof, Study director, Van Yuzuncu Yıl Unıversty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711355
- Sponsor's protocol ID
- YuzuncuYıl1
- Status last verified
- Jan 2023
- First submitted
- 9 Dec 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Moldenhauer JS, Adzick NS. Fetal surgery for myelomeningocele: After the Management of Myelomeningocele Study (MOMS). Semin Fetal Neonatal Med. 2017 Dec;22(6):360-366. doi: 10.1016/j.siny.2017.08.004. Epub 2017 Oct 12.
PubMed 29031539Sahni M, Alsaleem M, Ohri A. Meningomyelocele. 2023 Sep 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536959/
PubMed 30725644Mai CT, Isenburg JL, Canfield MA, Meyer RE, Correa A, Alverson CJ, Lupo PJ, Riehle-Colarusso T, Cho SJ, Aggarwal D, Kirby RS; National Birth Defects Prevention Network. National population-based estimates for major birth defects, 2010-2014. Birth Defects Res. 2019 Nov 1;111(18):1420-1435. doi: 10.1002/bdr2.1589. Epub 2019 Oct 3.
PubMed 31580536Rintoul NE, Sutton LN, Hubbard AM, Cohen B, Melchionni J, Pasquariello PS, Adzick NS. A new look at myelomeningoceles: functional level, vertebral level, shunting, and the implications for fetal intervention. Pediatrics. 2002 Mar;109(3):409-13. doi: 10.1542/peds.109.3.409.
PubMed 11875133Cochrane DD, Wilson RD, Steinbok P, Farquharson DF, Irwin B, Irvine B, Chambers K. Prenatal spinal evaluation and functional outcome of patients born with myelomeningocele: information for improved prenatal counselling and outcome prediction. Fetal Diagn Ther. 1996 May-Jun;11(3):159-68. doi: 10.1159/000264297.
PubMed 8739582Araki J, Jona M, Eto H, Aoi N, Kato H, Suga H, Doi K, Yatomi Y, Yoshimura K. Optimized preparation method of platelet-concentrated plasma and noncoagulating platelet-derived factor concentrates: maximization of platelet concentration and removal of fibrinogen. Tissue Eng Part C Methods. 2012 Mar;18(3):176-85. doi: 10.1089/ten.TEC.2011.0308. Epub 2011 Nov 22.
PubMed 21951067Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018 Jan;4(1):18-24. doi: 10.1159/000477353. Epub 2017 Jul 6.
PubMed 29457008Marx RE. Platelet-rich plasma (PRP): what is PRP and what is not PRP? Implant Dent. 2001;10(4):225-8. doi: 10.1097/00008505-200110000-00002. No abstract available.
PubMed 11813662Tamburrini G, Frassanito P, Iakovaki K, Pignotti F, Rendeli C, Murolo D, Di Rocco C. Myelomeningocele: the management of the associated hydrocephalus. Childs Nerv Syst. 2013 Sep;29(9):1569-79. doi: 10.1007/s00381-013-2179-4. Epub 2013 Sep 7.
PubMed 24013327Shaer CM, Chescheir N, Schulkin J. Myelomeningocele: a review of the epidemiology, genetics, risk factors for conception, prenatal diagnosis, and prognosis for affected individuals. Obstet Gynecol Surv. 2007 Jul;62(7):471-9. doi: 10.1097/01.ogx.0000268628.82123.90.
PubMed 17572919Oncel MY, Ozdemir R, Kahilogullari G, Yurttutan S, Erdeve O, Dilmen U. The effect of surgery time on prognosis in newborns with meningomyelocele. J Korean Neurosurg Soc. 2012 Jun;51(6):359-62. doi: 10.3340/jkns.2012.51.6.359. Epub 2012 Jun 30.
PubMed 22949965McLone DG. Care of the neonate with a myelomeningocele. Neurosurg Clin N Am. 1998 Jan;9(1):111-20.
PubMed 9405769Messing-Junger M, Rohrig A. Primary and secondary management of the Chiari II malformation in children with myelomeningocele. Childs Nerv Syst. 2013 Sep;29(9):1553-62. doi: 10.1007/s00381-013-2134-4. Epub 2013 Sep 7.
PubMed 24013325Mummareddy N, Dewan MC, Mercier MR, Naftel RP, Wellons JC 3rd, Bonfield CM. Scoliosis in myelomeningocele: epidemiology, management, and functional outcome. J Neurosurg Pediatr. 2017 Jul;20(1):99-108. doi: 10.3171/2017.2.PEDS16641. Epub 2017 Apr 28.
PubMed 28452655Wu PI, Diaz R, Borg-Stein J. Platelet-Rich Plasma. Phys Med Rehabil Clin N Am. 2016 Nov;27(4):825-853. doi: 10.1016/j.pmr.2016.06.002.
PubMed 27788903
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of the Effects of Platelet-Rich Plasma on Postoperative Complications After Meningomyelocele Sac Repair
- ClinicalTrials.gov ID
- NCT05711355
- Acronym / sponsor ID
- YuzuncuYıl1
- Conditions
- Meningomyelocele/Spina Bifida
- Keywords
- Meningomyelocele, myelomeningocele, neural tube defect, spina bifida, platelet-rich plasma, cerebrospinal fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction Meningomyelocele (MMC), a form of spina bifida, is the most common congenital anomaly of the central nervous system. It occurs in the first four weeks of pregnancy when the neural tube of the embryo fails to close. Neural tube defects may result in hydrocephalus, hindbrain herniation, and exposure to toxins in the amniotic fluid, with potential morbidity and mortality (1). Both environmental and genetic factors contribute to the etiology of MMC. The risk of MMC is increasing in the events of maternal exposure to valproate, alcohol, carbamazepine, or isotretinoin; high fever; malnutrition, especially folate or B12 deficiency, diabetes mellitus, or obesity during pregnancy (2). About 1,427 babies are born with spina bifida each year in the United States (1 in 2,758 births). Lower socioeconomic status and older maternal age are associated with higher neural tube defect incidence. The recurrence rate in subsequent pregnancies is about 2% to 3% (3). More than 80% of babies born with MMC require a ventriculoperitoneal shunt for hydrocephalus decompression (4). In 39% of the patients, functional motor deficits are at the affected level or higher, and more than half of these have functional motor deficits two levels higher than the affected level (5). The purpose of early closure of MMC defects is to preserve neural tissue function and prevent sepsis.
Platelet-rich plasma (PRP) is an autologous concentration of human platelets obtained from venous blood through proper centrifugation. It contains several growth factors including platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), platelet-derived factor 4 (PF-4), insulin-like growth factor (IGF-1), and transforming growth factor-beta (TGF-b) (6). There are approximately 150-400 10³/mm³ platelets in the blood and PRP contains between four and seven times this amount (7). When whole blood is collected from a patient for the generation of PRP, an anticoagulant is added. This usually contains citrate and disrupts the coagulation cascade by binding to calcium ions (8). PRP is used in orthopedic indications, wound healing, facial rejuvenation, hair restoration, and other conditions in which tissue renewal is central. The use of PRP for surgical and non-surgical wounds is advantageous, especially in patients with poor wound healing, poor blood supply, and slow cell turnover, and in cases where rapid healing is required.
In this study, we assessed whether the administration of PRP during the MMC pouch repair procedure can improve infant outcomes. This was measured by its ability to reduce CSF leakage, meningitis, local infection, skin necrosis, wound dehiscence, and hydrocephalus, and to accelerate the healing of the underdeveloped pouch tissue. These outcomes were compared with those of an MMC control group who did not receive PRP during surgery.
Materials and Methods This study included 40 infants with a diagnosis of MMC who were operated on at our neurosurgery clinic between February 2020 and May 2021. PRP was administered to 20 of the patients and 20 were followed up without PRP. All babies were born at term and fed with breast milk. All infants in the study were followed up in the neonatal intensive care unit. The mean birth weight was 2990 grams. In the PRP group, 10 of the 20 patients underwent primary defect repair and 10 underwent flap repair. In the non-PRP group, 14 patients underwent primary closure and six underwent flap closure. All operations were performed under general anesthesia. Blood was taken from each patient and the platelets were separated by centrifugation at 3200 rpm for five min in a 2 cc whole blood centrifuge device. The plasma was separated with the buffy coat layer. During MMC sac repair, a neural plate was formed and the dura was then made using opposing flaps from the fascia. After hemostasis was achieved, the defect was repaired and PRP was applied from the wound edge. The prepared PRP was applied to the dura and pouch repair and under the skin flap wound line.
Descriptive statistics were expressed as means, standard deviations, medians, ranges, frequencies, and ratios. The distribution of variables was measured with the Kolmogorov-Smirnov test. Independent sample t-tests and Mann-Whitney U tests were used for the analysis of quantitative independent data. Chi-square tests were used in the analysis of qualitative independent data, and the Fischer test was used when the chi-square test conditions were not met. Analyses were performed using SPSS 27.0 software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of Platelet-Rich Plasma after meningomyelocele sac repair | Active comparator | Procedure: Use of Platelet-Rich Plasma after meningomyelocele sac repair, Procedure: meningomyelocele sac repairPaitents treated with platelet-rich plasma injection and treated with according to guidelines |
| Control group of meningomyelocele sac repair | Active comparator | Procedure: meningomyelocele sac repairPaitents treated according to guidelines |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborn babies born with a meningomyelocele sac
Key exclusion criteria (1 listed)
- Newborn babies without a meningomyelocele sac
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Platelet-Rich Plasma after meningomyelocele sac repairWound healing with the use of Platelet-Rich Plasma after surgical meningomyelocele pouch repair | Procedure or surgery | Use of Platelet-Rich Plasma after meningomyelocele sac repair |
| meningomyelocele sac repairmeningomyelocele sac repair without Platelet-Rich Plasma | Procedure or surgery | Control group of meningomyelocele sac repair, Use of Platelet-Rich Plasma after meningomyelocele sac repair |
Primary outcome
Skin Dehicense Occurrence
Time frame: up to first 14 days after the surgery
Area of surgery has been examined daily for skin dehisence
Partial Skin Necrosis Occurrence
Time frame: up to first 14 days after the surgery
Area of surgery has been examined daily for skin necrosis
CSF Leak Occurrence
Time frame: up to first 14 days after the surgery
Area of surgery has been examined daily for CSF leakage
Local Infection Occurrence
Time frame: up to first 14 days after the surgery
Area of surgery has been examined daily for wound infection
1 secondary outcome
Hydrocephalus Occurrence
Time frame: birth to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Background: PubMed 29031539Moldenhauer JS, Adzick NS. Fetal surgery for myelomeningocele: After the Management of Myelomeningocele Study (MOMS). Semin Fetal Neonatal Med. 2017 Dec;22(6):360-366. doi: 10.1016/j.siny.2017.08.004. Epub 2017 Oct 12.
- Background: PubMed 30725644Sahni M, Alsaleem M, Ohri A. Meningomyelocele. 2023 Sep 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536959/
- Background: PubMed 31580536Mai CT, Isenburg JL, Canfield MA, Meyer RE, Correa A, Alverson CJ, Lupo PJ, Riehle-Colarusso T, Cho SJ, Aggarwal D, Kirby RS; National Birth Defects Prevention Network. National population-based estimates for major birth defects, 2010-2014. Birth Defects Res. 2019 Nov 1;111(18):1420-1435. doi: 10.1002/bdr2.1589. Epub 2019 Oct 3.
- Background: PubMed 11875133Rintoul NE, Sutton LN, Hubbard AM, Cohen B, Melchionni J, Pasquariello PS, Adzick NS. A new look at myelomeningoceles: functional level, vertebral level, shunting, and the implications for fetal intervention. Pediatrics. 2002 Mar;109(3):409-13. doi: 10.1542/peds.109.3.409.
- Background: PubMed 8739582Cochrane DD, Wilson RD, Steinbok P, Farquharson DF, Irwin B, Irvine B, Chambers K. Prenatal spinal evaluation and functional outcome of patients born with myelomeningocele: information for improved prenatal counselling and outcome prediction. Fetal Diagn Ther. 1996 May-Jun;11(3):159-68. doi: 10.1159/000264297.
- Background: PubMed 21951067Araki J, Jona M, Eto H, Aoi N, Kato H, Suga H, Doi K, Yatomi Y, Yoshimura K. Optimized preparation method of platelet-concentrated plasma and noncoagulating platelet-derived factor concentrates: maximization of platelet concentration and removal of fibrinogen. Tissue Eng Part C Methods. 2012 Mar;18(3):176-85. doi: 10.1089/ten.TEC.2011.0308. Epub 2011 Nov 22.
- Background: PubMed 29457008Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018 Jan;4(1):18-24. doi: 10.1159/000477353. Epub 2017 Jul 6.
- Background: PubMed 11813662Marx RE. Platelet-rich plasma (PRP): what is PRP and what is not PRP? Implant Dent. 2001;10(4):225-8. doi: 10.1097/00008505-200110000-00002. No abstract available.
- Background: PubMed 24013327Tamburrini G, Frassanito P, Iakovaki K, Pignotti F, Rendeli C, Murolo D, Di Rocco C. Myelomeningocele: the management of the associated hydrocephalus. Childs Nerv Syst. 2013 Sep;29(9):1569-79. doi: 10.1007/s00381-013-2179-4. Epub 2013 Sep 7.
- Background: PubMed 17572919Shaer CM, Chescheir N, Schulkin J. Myelomeningocele: a review of the epidemiology, genetics, risk factors for conception, prenatal diagnosis, and prognosis for affected individuals. Obstet Gynecol Surv. 2007 Jul;62(7):471-9. doi: 10.1097/01.ogx.0000268628.82123.90.
- Background: PubMed 22949965Oncel MY, Ozdemir R, Kahilogullari G, Yurttutan S, Erdeve O, Dilmen U. The effect of surgery time on prognosis in newborns with meningomyelocele. J Korean Neurosurg Soc. 2012 Jun;51(6):359-62. doi: 10.3340/jkns.2012.51.6.359. Epub 2012 Jun 30.
- Background: PubMed 9405769McLone DG. Care of the neonate with a myelomeningocele. Neurosurg Clin N Am. 1998 Jan;9(1):111-20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Edip Akyol, Ass. Prof study director
Van Yuzuncu Yıl Unıversty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Platelet-Rich Plasma after meningomyelocele sac repair and meningomyelocele sac repair in people with Meningomyelocele/Spina Bifida, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Dehicense Occurrence (time frame: up to first 14 days after the surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05711355, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.