Platelet-Rich Plasma-A Safe and Cost-effective Dural Sealant in Spinal Surgeries-A Systematic Review

doi:10.21203/rs.3.rs-4498249/v1

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Systematic Review

Platelet-Rich Plasma-A Safe and Cost-effective Dural Sealant in Spinal Surgeries-A Systematic Review

https://doi.org/10.21203/rs.3.rs-4498249/v1

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Introduction

Incidental durotomy (ID) is a common complication of otherwise rewarding lumbar decompression surgeries. An effective water-tight closure of the dura can potentially avoid cerebrospinal fluid (CSF) leakage and its dreaded sequel. Several sealants, grafts, and patches are used; however, the cost constrains its utility in resource-limited settings. Platelet-rich plasma (PRP) has been found effective in wound healing and adhesive properties and hence a potential adjunct for watertight closure of dura. This systematic review was conducted to highlight the existing literature on the utility of PRP in spinal procedures for the managing of CSF leaks.

Methods

The review was conducted based on the PRISMA guidelines. After a comprehensive database search through three databases (PubMed, Scopus, and Cochrane Library), studies assessing the role of PRP in CSF leaks or for the water-tight closure of dura were included. The study descriptions, demographic details, methodology, and outcomes were assessed.

Results

A total of six studies were included. In vitro studies and animal trials demonstrated the efficacy of PRP in achieving watertight dural closure and prevention of CSF leaks when standard suturing techniques failed. PRP application in rat models have been shown to cause increased dura mater thickness and enhanced vascularity. Clinical cases revealed mixed outcomes, with some patients experiencing symptom relief and improved radiological findings after PRP interventions, while a minority faced recurrent symptoms.

Conclusion

PRP is a promising tool to achieve water-tight dural closure. Although the clinical evidence is limited at this juncture, its feasibility, cost-effectiveness, and safety profile make it suitable for initiating clinical trials to assess its optimal clinical application.

Platelet-rich Plasma

Incidental Duratomy

Dural Sealant

Water-tight Dural Closure

Incidental durotomy (ID) is a common complication of otherwise rewarding lumbar decompression surgeries. The incidence varies depending on the type and extent of the surgery, with the highest occurrence in the lumbar region (14.5%), particularly in recurrent settings ¹. ID can be managed without a long-term sequel. However, it has a wide array of complications including headache, dizziness, dural cutaneous fistula, pseudo-meningocele, wound infection, arachnoiditis, and meningitis.^2,3

Effective closure is a paradigm for satisfactory outcomes and is particularly challenging⁴. Primary suture repair is accepted as a gold standard ^5,6. Various surgical techniques have been used in the past for the management of dural leaks ^5,7,8. Traditionally nylon, polyproline, and polytetrafluoroethylene have been used in an interrupted or running-locked suture technique method with similar outcomes. However, a water-tight closure is at times technically daunting or ineffective necessitating secondary augmentation. Grannum et al. suggested that dural repair can be done without sutures if the tear is located anteriorly or is inaccessible with comparable outcomes ⁹.

Sealants have been introduced to strengthen the suture line, suturing needle holes, and irreparable or diffuse leaks. They may be synthetic or biological (polyethylene glycol or biological absorbable fibrin) and help in polymerization ^10–13. The debate about their efficacy is mixed, with the data suggesting either equivocal results or no added benefits ^12,14, Deficient dura can be grafted with various natural materials (autologous fat, muscles, or fascia) or synthetic patches (collagen matrix, gelatin sponge, polyglycolic acid sheet, collagen-coated with fibrin) ¹⁰. The use of synthetic or absorbable sponges, polyglycolic acid sheets, and collagen patch coated with fibrin has also been approved. These flexible substitutes can be shaped as per need and are especially helpful with large defects ¹⁵. These patches release growth factors and there is compelling evidence that the use of grafts or patches is an effective option and helps in decreasing the rate of CSF leakage ¹³. Their high cost significantly limits their use in resource-limited settings.

Platelet-rich plasma (PRP), derived from autologous whole blood containing a concentrated source of platelets, contains multiple growth factors such as fibroblast, epithelial, endothelial proliferating factors, and cytokines. These factors help in cellular proliferation, differentiation, and regeneration ¹⁶. Initially used as a transfusion product in cases of thrombocytopenia, its applications have expanded to various medical disciplines, including maxillofacial surgery, sports injuries, cardiac surgery, pediatric surgery, gynecology, urology, plastic surgery, dermatology and ophthalmology for its anti-inflammatory properties and cellular proliferation^17,18. Due to the wound healing and adhesive properties, it has been used as a scaffolding layer for dural repair. Although it has not been widely used, initial studies are promising ^19,20. As prepared from the receiver’s blood, its application has nearly no reported complications or adverse effects ^16,17.

The use of sealants and synthetic patches is on the rise in decompressive spinal procedures. The use of PRP in liquid as well as membranous form can potentially serve as a cost-effective alternative. We, therefore review the studies where PRP was used after spinal procedures for the management of dural CSF leaks.

The present study was conducted based on the PRISMA guidelines.

Search Strategy

A comprehensive database search was conducted through PubMed, Scopus, and Cochrane Library databases using the following search terms: (platelet rich plasma OR PRP) AND ((spinal surg* OR (meningomyelocele OR MMC) OR (post dural puncture headache OR post lumbar puncture headache OR PDPH) OR (CSF OR cerebrospinal fluid) OR dura*)). ClinicalTrials.gov, EU Clinical Trials Register, and the Cochrane Library were the portals used to collect the details of all the ongoing clinical trials for PRP as sealant.

Inclusion and Exclusion Criteria

All in-vivo, in-vitro, animal and human trials assessing the role of PRP in CSF leaks or for the water-tight closure of dura were included. Any article not assessing the variable of interest or not in English language was excluded.

Data Extraction

The study descriptions, demographic details, methodology, and outcomes were assessed and reported.

Following database search, screening, and eligibility assessment, 6 studies were included in the review. The PRISMA flowchart for article selection is illustrated in Fig. 1. The demographics, objectives, and outcomes of individual studies have been summarized in Table 1.

Outcomes

Animal Studies

Vasilikos et al. developed an in vitro testing apparatus for hydrostatic assessment of water-tight dura closure. Using freshly harvested bovine dura mater, a standardized 20-mm incision was closed using a running suture, and the leak pressure was initially measured without PRP augmentation. The secondary leak pressure was measured following the introduction of PRP augmentation. The PRP augmentation consistently strengthened the closure, with a four times higher leak pressure compared to standard running suture technique ²¹.

Paksoy K et al. conducted a study on albino female rats to assess the difference in thickness of dura mater after applying PRP compared with the conventional suturing technique. The first group had dural incision without repair. Dural incision was closed with suturing (10/0 Vicryl) in second group, and PRP was applied over sutured dura in third group. There were no significant differences in dura mater thickness and surface area between Group 1 and Group 2. However, a significant increase was observed in both dura mater thickness and surface area in the third group. The PRP-treated group also displayed a higher occurrence of new bone areas secondary to increased osteoblastic activity and high vascularity due to increased angiogenesis²².

Silverberg et al. in an animal-based trial evaluated the physiological adhesive for its ability to seal surgically produced dural CSF leaks in dogs. All dural grafts applied without PRP resulted in CSF leaks within 1 to 2 hours, whereas, those with PRP remained intact. After 2 to 4 weeks, no CSF leaks were observed in either group. Microscopic examination revealed fibrous union of the graft to the dura in the PRP group, while graft slippage was noted in the control ²³.

Human Studies

Theys et al. conducted a retrospective study assessing the leucocyte and platelet-rich fibrin plugs/membranes for several neurosurgical procedures out of which two were spinal dural leaks. Both cases involved chronic CSF leaks with symptomatic intracranial hypotension and pseudomeningocele. The patients had three revision surgeries for dural repair with collagen biomatrix and dural sealant, muscle/fascia graft, external lumbar drainage, and repetitive blood patches. The surgeon later utilized Leukocyte- and Platelet-Rich Fibrin (L-PRF) membranes for dural closure, sutured into the dura in one case and as onlay grafts to reinforce dural closure in other case. One patient recovered at six weeks’ follow-up while the other patient suffered recurrence.

Qureshi et al. reported a case of a patient with headache secondary to a lumbar puncture performed to exclude meningitis. The patient showed complete resolution of symptoms after receiving injectable PRP ²⁴. Another case report showed the successful utilization of a PRP patch in a patient with post-dural puncture headache (PDPH) after a failed standard epidural blood patch.²⁵ The headache gradually decreased and completely resolved after 3 days. The 1-week follow-up MRI revealed apparent radiological improvement with decreased pachymeningeal contrast enhancement. The patient was reported to be free of symptoms at the last follow-up of about one month.²⁵

Table 1

summaries of the included studies.
Study	Study design	Population	Groups	No. of Cases	Objective	Outcome
Vasilikos et al. (2020) ²¹	In-vitro study	Fresh bovine dura preparations harvested from 4-6-month-old bovine skulls	Group A: Dura-closure with running suture only, Group B: PRF-augmented group	26	Augmenting the classical dura suture (Premicron 4–0 running simple closure suture) with a combination of PRF to assess for water-tightness of dura closure	Group A had a leak pressure of 10.5 ± 1.2 cmH₂O while Group B had a leak pressure of 47.2 ± 2.6 cm H₂O. (p < 0.0001)
Paksoy et al. (2021) ²⁶	Animal-based clinical trial	Wistar Albino female rats	Group 1 (Control group): Craniectomy + dural incision Group 2 (only suturing group): Craniectomy + dural incision + suturing (10/0 Vicryl) Group 3 (PRP group): Craniectomy + dural incision + suturing + PRP (10/0 Vicryl and PRP was applied over the sutured dura.)	30	Histopathological effects of dural suture technique with combined suturing and topically applied PRP on dural healing.	No significant difference was observed in the thickness and surface areas of dura mater between groups 1 and 2. A significant increase (p < 0.05) was observed in the thickness and surface areas of dura mater in Group 3 compared to others. New bone regions and new vasculature were observed more frequently in this group.
Silverberg et al. (1977) ²³	Animal-based trial	Large montreal dogs	Group A: Graft (pericranial fascia) + platelets + fibrinogen + thrombin Group B: Graft alone (pericranial fascia)	14	To test a combination of platelets, fibrinogen, and thrombin for its ability to seal surgically produced CSF leaks in dogs.	In acute experiments (1–2 h) when graft + platelets were applied on six dural defects, none leaked while in the control group (n = 5), all leaked. In the long-term (4–6 weeks) none leaked in group A and there was good graft incorporation and good coverage. In this group, two had cerebral herniation through dural defect. In group B, two showed slippage of graft with coverage of brain via thickened arachnoid.
Theys et al. (2018) ¹⁹	Retrospective database study	2 spinal dural repairs (skull base surgery, posterior fossa surgery and spinal cases were part of the study but only the spinal ones were included in our review).	-	2/47	To describe the safety, feasibility, and applicability of L-PRF membranes and plugs in spinal surgery	L-PRF membranes were used in 2 spinal surgeries. These were used as onlay grafts to augment sealing or sutured into a defect. No short-term complications recorded. Postoperative CSF leakage was present in one spinal CSF leak repair.
Qureshi et al. (2018) ²⁴	Case Report	Post lumbar puncture which was performed to exclude meningitis.	-	1	Report of a patient with severe headaches post-lumbar puncture, treated with epidural injection of PRP	Patient-reported complete resolution of headaches immediately after the procedure.
Gunaydin et al. (2017) ²⁵	Case Report	Post-partum female with post lumbar puncture headache	-	1	To report successful utilization of an epidural patch with PRP for persistent post-dural puncture headache refractory to standard epidural blood patch.	Clinical and radiological improvements were observed a week after the epidural patch using PRP.
PRF: Platelet rich fibrin, PRP: Platelet rich Plasma, L-PRF: Leukocyte- and Platelet-Rich Fibrin

Most studies including in-vivo, animal-based trials, and case reports on utilizing PRP for the management of dural CSF leaks have shown it to be efficacious for the watertight closure of dura without any reports of adverse effects.

Preparation of PRP

The preparation of PRP is relatively simple and cost-effective procedure. It usually includes acquiring 35–40 mL of peripheral blood from the patient using an 18G needle. Cubital veins are used for sampling. An anticoagulant such as acid citrate dextrose is then added to the collected sample ^27–29. Blood is then passed through two cycles of centrifugation, the first of which is done at 1600rpm for 15 minutes which stratifies blood into three strata i.e. the basal layer (red layer) containing the erythrocytes, the middle (white) layer containing the leukocytes, and the top (yellow) layer comprising of the plasma, platelets, and growth factors. A second cycle is done at 2800 rpm for 7 minutes) which concentrates platelet-rich and platelet-poor plasma components. This process requires the usage of a manual centrifuge ^27–29. Other than the fluid PRP, there is a solid one as well which comprises a 3d-matrix and is manually compressed and flattened to form a membrane. The membrane, once formed, can be used for up to three hours^21,24,27.

PRP in Spinal Procedure

The role of PRP has been evaluated in various spinal procedures. Levi et al. assessed the ability of intradiscal PRP to relieve discogenic lumbar pain while studying musculoskeletal disorders, and found improvement in their pain and function³⁰. Kristin et al. used the stromal vascular fraction and PRP for degenerative disc disease and reported improvement in spinal flexion range of motion and pain with less number of complications³¹. Tuakli-Wosornu et al. evaluated the effect of PRP in symptomatic degenerative intervertebral discs and found improvement in their pain and functional capacity³². L-Kubota et al. analyzed patients undergoing transforaminal lumbar interbody fusion after spondylolisthesis and reported an increase in the rate of bony fusion after application of PRP³³. Ibrahim et al. in their pilot study explored the efficacy and safety of PRP for the nonoperative management of shoulder tendinopathy in spinal cord injury patients and found convincing results³⁴. Rappl et al. evaluated the usage of PRP in the healing of chronic wounds of patients with spinal cord injury and concluded that PRP facilitates the healing process of chronic nonhealing ulcers³⁵.

PRP for Anterior Skull Base Reconstruction

Apart from spinal surgeries, the role of PRP has also been evaluated in several other neurosurgical procedures. It has been reported that L-PRP promoted early regeneration of the sphenoid sinus mucosa for closure of endoscopic approaches without any complications within the first 30 postsurgical days³⁶. Felipe et al. utilized L-PRP for skull base reconstruction following endoscopic endonasal surgery and compared them with patients who underwent an endoscopic endonasal approach and who underwent reconstruction using a standard technique. They reported significantly lower postoperative CSF leaks in the L-PRP group compared to the standard reconstruction group (2.6%, 10.8%; p 0.024). This difference was also significant in patients with intraoperative high-flow leaks (3.1%, 11.7%; p 0.048). L-PRF was also reported to reduce postoperative CSF leak by 76% in cases with intraoperative CSF leak (relative risk 0.24, 95% CI 0.06–0.87) and by 73% of patients with high-flow leak (relative risk 0.27, 95% CI 0.07–0.99). In patients undergoing surgery for diagnoses other than adenomas, in 13.4% of patients who had standard reconstruction reported postoperative leak, whereas there was no report in the PRP group (p = 0.047) ²⁰. Rasmussen et al. reported the feasibility and protocol of using L-PRP in the reconstruction of endoscopic approaches to the sellar region ³⁶.

Ongoing Trials for PRP as Sealant

Various clinical trials are currently being conducted across multiple medical specialties to evaluate the possible utility of platelet-rich plasma (PRP) as a sealant. We ran a systemic search through ClinicalTrials.gov, EU Clinical Trials Register, and Cochrane Library to identify these ongoing trials, summarized in Table 2 ^37–43.

Table 2

Ongoing clinical trials on PRP
Trial	Title	Objective
NCT03812120 ³⁸	L-PRF in Cranial Surgery: a Prospective, Randomized Trial	To demonstrate that the use of L-PRF is non-inferior to classical fibrin sealants in cranial surgeries.
NCT03910374 ³⁹	Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction	To investigate prospectively, the effectivity of L-PRF membranes for skull base reconstruction after endoscopic endonasal skull base surgery versus classical closure techniques.
NCT05264467 ⁴⁰	Use of Leukocyte and Platelet-rich Fibrin Plasma (L-PRF) for the Prevention of Anastomotic Leakage in Colorectal Anastomosis	To assess the feasibility of using L-PRF in colorectal surgery and to determine the incidence of anastomotic leakage after colorectal anastomosis.
NCT05437744 ⁴¹	Assessment of Soft Tissue Healing Over Immediately Placed Implant Sealed With Platelets Rich Fibrin Versus Cyanoacrylate Glue (a Randomized Controlled Clinical Trial)	To clinically compare the soft tissue healing, height, and thickness over immediate implants placed in type I sockets sealed by PRF to those sealed by a Cyanoacrylate glue.
NCT05711355 ⁴²	A Randomized Trial of the Effects of Platelet-Rich Plasma on Postoperative Complications After Meningomyelocele Sac Repair	To minimize cerebrospinal fluid leakage and accelerate the healing of the immature pouch tissue following corrective surgery for meningomyelocele by administering Platelet-rich plasma.
NCT01672593 ⁴³	A Randomized Controlled Trial to Evaluate Endoscopy Assisted Fibrin Glue Application in the Treatment of Low-Output enterocutaneous fistulas	To compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG) and a commercially available fibrin sealant Bioseal® in the management of patients with low-output volume enterocutaneous fistulas.
NCT03500796 ³⁷	Combined Amniotic Membrane and Platelet Rich Plasma Clot for Management of Central Corneal Perforation	To evaluate the use of amniotic membrane and platelet rich plasma clot for closure of central corneal perforation

The available evidence consists of in-vitro experiments, animal trials, and a sparse number of clinical cases. This diversity in methodologies and the lack of clinical data make it challenging to draw comprehensive conclusions. Furthermore, the variability in outcomes observed in the clinical cases underscores the need for controlled clinical trials, therefore further research and investigation are crucial to validate and refine the potential role of PRP in these medical applications.

The current literature presents compelling evidence regarding the potential benefits of PRP in the management of CSF leaks. The majority of these investigations indicate the efficacy of PRP for achieving watertight dural closure without adverse effects. Furthermore, the cost-effectiveness of PRP preparation also supports its use, although no data compares the effectiveness of PRP compared to commercially available dural sealants with clinically proven effectiveness. Further research is essential to establish the broader and more standardized use of PRP.

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Gerven LV, Leuven UZ (2021) Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction. Universitaire Ziekenhuizen KU Leuven, -PRF&aggFilters=studyType:int&limit=100&term=closure&rank=2. https://clinicaltrials.gov/study/NCT03910374?intr=Dural%20closure%20with%20L
Leukocyte (2022) and Platelet-Rich Fibrin Plasma for the Prevention of Anastomotic Leakage in Colorectal Anastomosis. Universidad de Concepcion, &aggFilters=studyType:int&page=2&limit=50&rank=62. https://clinicaltrials.gov/study/NCT05264467?intr=platelet-rich%20fibrin
Immediately Placed Implant Sealed With Platelets Rich Fibrin Versus Cyanoacrylate Glue. Alexandria University; (2022) https://clinicaltrials.gov/study/NCT05437744?intr=platelet-rich%20fibrin&aggFilters=studyType:int&page=2&limit=50&rank=78
The Effects of Platelet-Rich Plasma on Postoperative Complications After Meningomyelocele. Yuzuncu Yıl University; (2023) https://clinicaltrials.gov/study/NCT05711355?intr=platelet-rich%20&aggFilters=studyType:int&limit=100&term=cranial&rank=4
Hospital J (2014) China; https://clinicaltrials.gov/study/NCT01672593?intr=platelet-rich%20&aggFilters=studyType:int&limit=100&term=sealant&rank=2

The authors declare no competing interests.

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Platelet-Rich Plasma-A Safe and Cost-effective Dural Sealant in Spinal Surgeries-A Systematic Review

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Abstract

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Introduction

Methodology

Results

Outcomes

Animal Studies

Human Studies

Discussion

Preparation of PRP

PRP in Spinal Procedure

PRP for Anterior Skull Base Reconstruction

Ongoing Trials for PRP as Sealant

Conclusion

References

Additional Declarations

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