Dataset Information

Leukocyte- and platelet-rich fibrin in cranial surgery: study protocol for a prospective, parallel-group, single-blinded randomized controlled non-inferiority trial {1}.

ABSTRACT:

Background

CSF leakage is a major complication after cranial surgery, thus, adequate dural closure must be performed. Commercially available fibrin sealants are currently considered the gold standard for dural closure, but problems have been reported regarding safety, efficacy, and costs. This trial aims to investigate autologous leukocyte- and platelet-rich fibrin (L-PRF) as an alternative to commercially available fibrin sealants.

Methods/design

This single-blinded, prospective randomized controlled interventional trial aims to demonstrate the non-inferiority of L-PRF compared to commercially available fibrin sealants for dural closure. This trial will include patients undergoing cranial neurosurgery (supratentorial and infratentorial) with intentional opening of the dura. Patients are randomized in a 1:1 fashion comparing L-PRF to commercially available fibrin sealants. The primary endpoint is postoperative CSF leakage within 12 weeks after surgery. Secondary endpoints are complications such as bleeding or wound infections. Additionally, a cost-effectiveness analysis is performed.

Discussion

With this trial, we will evaluate the safety and efficiency of L-PRF compared to commercially available fibrin sealants.

Trial registration

ClinicalTrials.gov NCT03812120. Registered on 22 January 2019.

SUBMITTER: Coucke B

PROVIDER: S-EPMC10034240 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Publications

Leukocyte- and platelet-rich fibrin in cranial surgery: study protocol for a prospective, parallel-group, single-blinded randomized controlled non-inferiority trial {1}.

Coucke Birgit B Van Hoylandt Anaïs A van Loon Johannes J Van Calenbergh Frank F Van Gerven Laura L Theys Tom T

Trials 20230323 1

<h4>Background</h4>CSF leakage is a major complication after cranial surgery, thus, adequate dural closure must be performed. Commercially available fibrin sealants are currently considered the gold standard for dural closure, but problems have been reported regarding safety, efficacy, and costs. This trial aims to investigate autologous leukocyte- and platelet-rich fibrin (L-PRF) as an alternative to commercially available fibrin sealants.<h4>Methods/design</h4>This single-blinded, prospective ...[more]

PMID: 36959672

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Project description:Background: Leukocyte and platelet-rich fibrin (L-PRF) may be considered a co-adjuvant intervention that may play a key role in blood coagulation and tissue repair after nail surgeries. The aim of this study was to determine the effectiveness of L-PRF versus nitrofurazone on the post-surgical bleeding and wound cicatrization period in patients with bilateral onychocryptosis during surgeries of chemical matrixectomies with 88% phenol solution. Methods: A randomized single-blind clinical trial was registered with the European Clinical Trials Database (EudraCT) with identification number 2016-002048-18. Twenty healthy participants with bilateral onychocryptosis (n = 40) were recruited and bilaterally received both protocols for both halluces. Patients with a mean age mean of 45.55 ± 12.19 years attended a specialized foot and ankle surgery clinic. Both halluces of each patient were randomized and allocated to receive L-PRF (experimental group; n = 20 halluces) or nitrofurazone (control group; n = 20 halluces) interventions in conjunction with surgery of chemical matrixectomies with 88% phenol solution for bilateral ingrown of toenail border (medial and lateral). Patients were blinded to their intervention in each hallux. The primary outcome measurement was post-surgical bleeding. The secondary outcome measurements were post-surgical pain intensity, inflammation, infection, analgesic intake, and wound cicatrization period. Results: Statistically significant differences (p < 0.001) were found between both groups showing a reduction for wound cicatrization period and post-surgical bleeding for the L-PRF intervention with respect to nitrofurazone treatment. The rest of the outcome measurements did not show any statistically significant differences (p > 0.05). Conclusions: L-PRF rather than nitrofurazone in conjunction with chemical matrixectomies performed with 88% phenol solution reduced the wound cicatrization period and bleeding after nail surgery. Thus, L-PRF may be considered a first-line co-adjuvant intervention for patients who suffer from nail problems, such as onychocryptosis, that require surgical procedures.

Project description:The aim of this study was to evaluate the effect of local and systemic administration of antimicrobials to leukocyte- and platelet-rich fibrin (L-PRF). For part A, 16 tubes of venous blood were collected from each of eight systemically healthy subjects. Prior to blood centrifugation, 12 of the 16 tubes were injected with 0.125 ml, 0.25 ml or 0.50 ml metronidazole solution. One set of L-PRF membranes was used to assess the release of vascular endothelial growth factor AB, platelet-derived growth factor, transforming growth factor beta 1, and bone morphogenetic protein 2 at indicated time points. The metronidazole release over time by L-PRF membranes was also evaluated. The remaining L-PRF membranes were placed on the surface of agar plates inoculated with three different periodontal pathogens to determine their antibacterial activity. For part B, another six subjects were enrolled with three subjects taking 2 g amoxicillin and three subjects 500 mg metronidazole as prophylaxis prior to a periodontal treatment. Before and 2 h after consuming one of the prescribed antimicrobials, three tubes of blood were collected for preparing L-PRF membranes. These membranes were used to measure the antibacterial activity against periodontal pathogens. No statistically significant difference could be found in the release of growth factors between L-PRF membranes with and without incorporation of metronidazole solution. The release of metronidazole could be detected up to day 3, however with the highest concentration during the first 4 h. This concentration was dose dependent. The antibacterial capacity of L-PRF membranes increased significantly for both the systemic intake, and after the addition of metronidazole solution to the blood tubes before centrifugation, the latter again dose dependent. The antibacterial capacity of L-PRF against the periodontal pathogens tested can significantly be enhanced by the addition of antimicrobials, without disadvantage for the release of growth factors.

Dataset Information

Leukocyte- and platelet-rich fibrin in cranial surgery: study protocol for a prospective, parallel-group, single-blinded randomized controlled non-inferiority trial {1}.

Background

Methods/design

Discussion

Trial registration

Publications

Leukocyte- and platelet-rich fibrin in cranial surgery: study protocol for a prospective, parallel-group, single-blinded randomized controlled non-inferiority trial {1}.

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