Dural Medical Adhesive for Watertight Sealing in Dural Repair
4 août 2026 mis à jour par: Medprin Regenerative Medical Technologies Co., Ltd.
A Multicenter, Single-blind, Randomized Controlled Clinical Trial on the Safety and Effectiveness of Dural Medical Adhesive for Watertight Sealing in Dural Repair
This is a prospective, multicenter, single-blind, randomized controlled superiority clinical trial of dural medical adhesive for watertight sealing after primary spinal dural repair to prevent cerebrospinal fluid (CSF) leakage.
A total of 141 patients with intraoperative CSF leakage after primary dural repair from 7 medical centers will be enrolled at a 2:1 randomization ratio (94 in adhesive group, 47 in standard treatment control group).
Intraoperative watertight sealing success rate is the primary outcome.
Postoperative CSF leakage rate at day 10±5 and day 90±7, drainage volume/duration, and adverse events/serious adverse events within 90 days are secondary outcomes to evaluate the safety and effectiveness of the investigational device.
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Description détaillée
The investigational product is dural medical adhesive indicated for watertight sealing of dural defects in spinal surgery to prevent CSF leakage. This superiority trial adopts a prospective, multicenter, single-blind, randomized controlled design with 7 participating neurosurgical centers across China. Eligible patients are adults with visible CSF leakage after one-layer primary dural repair confirmed by intraoperative visualization, Valsalva maneuver or hemostatic sponge test. Subjects are randomly assigned 2:1 via sealed envelopes to two groups.
Intervention group: standard primary dural repair + dural medical adhesive evenly coated on the repair site for instant watertight sealing; a second application is allowed if persistent leakage occurs after first use.
Control group: standard treatment including autologous fat/fascia/muscle graft or reinforced suture after primary repair without medical adhesive.
All participants receive follow-up at postoperative day 10±5 (Visit 1) and day 90±7 (Visit 2). Primary efficacy endpoint is intraoperative successful watertight sealing without CSF leakage. Secondary endpoints include postoperative CSF leakage incidence at two time points, postoperative drainage volume and indwelling duration, and overall safety profiles including all adverse events and serious adverse events within 90 days post-operation. Statistical analyses will be performed on Full Analysis Set (FAS) and Per Protocol Set (PPS) for efficacy, and Safety Set (SS) for safety evaluation.
Type d'étude
Interventionnel
Inscription (Réel)
141
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Beijing, Chine
- Peking University Third Hospital
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Beijing, Chine
- Xuanwu Hospital, Capital Medical University
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Guangzhou, Chine
- Nanfang Hospital, Southern Medical University
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Nanchang, Chine
- The First Affiliated Hospital of Nanchang University
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Shenzhen, Chine
- Shenzhen Second People's Hospital
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Xi'an, Chine
- Xi'an Honghui Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Aged 18-75 years old, any gender.
- Undergoing spinal surgery with dural incision, traumatic tear or defect requiring primary repair.
- Intraoperative confirmed CSF leakage after primary dural repair via naked eye, microscopy, Valsalva maneuver or hemostatic sponge test.
- Patient or legal guardian voluntarily signs written informed consent form.
Exclusion Criteria:
- Participated in another interventional clinical trial within 1 month before surgery.
- Severe cardiac, hepatic, renal or hematological disease unable to tolerate spinal surgery.
- Known hypersensitivity to any component of dural medical adhesive (polyethylenimine, 4-arm PEG succinimidyl glutarate, brilliant blue, ε-poly-L-lysine hydrochloride).
- History of severe anaphylaxis or immunodeficiency disorders.
- Expected survival less than 3 months post-operation.
- Pregnant, lactating female or women planning pregnancy within 3 months after surgery.
- Poor treatment compliance judged by investigator, unable to complete full follow-up visits.
- Unable to understand trial information and cooperate with assessment.
- Intraoperative dural defect that cannot receive primary sutured repair.
- Class III contaminated surgical wound or active infection at operation site.
- Any other condition judged inappropriate for trial participation by investigator.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Dural Medical Adhesive Treatment Group
After routine primary suture repair of spinal dural defects and intraoperative confirmation of cerebrospinal fluid leakage, evenly apply the investigational dural medical adhesive to the sutured repair area.
After the adhesive is fully cured, perform Valsalva maneuver / hemostatic sponge test to recheck watertight sealing status.
One additional application of the adhesive is permitted if leakage persists after the first application.
Postoperative routine drainage and standardized follow-up are implemented.
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After primary suture repair of spinal dural defect with intraoperative confirmed cerebrospinal fluid leakage, evenly coat the adhesive over the sutured area.
After curing, use Valsalva maneuver or hemostatic sponge test to check sealing effect.
One repeated application is permitted if leakage persists.
Postoperative drainage and unified follow-up schedule are performed.
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Comparateur actif: Standard Conventional Treatment Control Group
After routine primary suture repair of spinal dural defects with confirmed intraoperative cerebrospinal fluid leakage, adopt clinically conventional reinforcement measures: autologous fat/fascia/muscle transplantation or supplementary interrupted suturing for leak blocking, without using any dural sealing adhesive products.
Recheck sealing effect intraoperatively by Valsalva maneuver / hemostatic sponge test, followed by postoperative routine drainage and identical follow-up schedule as the experimental group.
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After primary suture repair of spinal dural defect with intraoperative confirmed cerebrospinal fluid leakage, adopt conventional clinical reinforcement methods including autologous fat/fascia/muscle graft or supplementary suturing, without using any dural sealing adhesive products.
Intraoperative sealing verification and postoperative follow-up schedule are identical to the experimental group.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Intraoperative Watertight Sealing Success Rate
Délai: Intraoperatively (Visit 0)
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Proportion of subjects with no intraoperative CSF leakage confirmed by direct vision, Valsalva maneuver or hemostatic sponge test after assigned intervention.
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Intraoperatively (Visit 0)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Postoperative CSF Leakage Rate at Day 10±5
Délai: Postoperative day 10±5 (Visit 1)
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Incidence of clinically confirmed CSF leakage via drainage fluid volume, MRI imaging or intracranial hypotension symptoms within 10±5 days post-surgery.
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Postoperative day 10±5 (Visit 1)
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Postoperative CSF Leakage Rate at Day 90±7
Délai: Postoperative day 90±7 (Visit 2)
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Incidence of delayed CSF leakage, pseudomeningocele or wound CSF leakage confirmed by MRI or clinical manifestations within 90±7 days post-operation.
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Postoperative day 90±7 (Visit 2)
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Postoperative Drainage Volume and Drain Indwelling Duration
Délai: Postoperative day 10±5 (Visit 1)
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Daily drainage fluid volume from surgical drain and total catheter retention time for patients with postoperative drainage tube placement.
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Postoperative day 10±5 (Visit 1)
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Incidence of All Adverse Events and Serious Adverse Events
Délai: From surgery to postoperative day 90±7
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Overall occurrence rate of treatment-emergent adverse events and serious adverse events related or unrelated to the dural medical adhesive throughout the 90-day follow-up period.
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From surgery to postoperative day 90±7
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
29 mai 2024
Achèvement primaire (Réel)
19 juin 2025
Achèvement de l'étude (Réel)
28 juillet 2025
Dates d'inscription aux études
Première soumission
4 août 2026
Première soumission répondant aux critères de contrôle qualité
4 août 2026
Première publication (Réel)
10 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MP-CTP-YYJ2024
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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