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Dural Medical Adhesive for Watertight Sealing in Dural Repair

4. august 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

141

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Beijing, Kina
        • Peking University Third Hospital
      • Beijing, Kina
        • Xuanwu Hospital, Capital Medical University
      • Guangzhou, Kina
        • Nanfang Hospital, Southern Medical University
      • Nanchang, Kina
        • The First Affiliated Hospital of Nanchang University
      • Shenzhen, Kina
        • Shenzhen Second People's Hospital
      • Xi'an, Kina
        • Xi'an Honghui Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: Dural medical adhesive
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.
Aktiv komparator: 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.
Procedure: Standard dural reinforcement surgery
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intraoperative Watertight Sealing Success Rate
Tidsramme: Intraoperatively (Visit 0)
Proportion of subjects with no intraoperative CSF leakage confirmed by direct vision, Valsalva maneuver or hemostatic sponge test after assigned intervention.
Intraoperatively (Visit 0)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Postoperative CSF Leakage Rate at Day 10±5
Tidsramme: Postoperative day 10±5 (Visit 1)
Incidence of clinically confirmed CSF leakage via drainage fluid volume, MRI imaging or intracranial hypotension symptoms within 10±5 days post-surgery.
Postoperative day 10±5 (Visit 1)
Postoperative CSF Leakage Rate at Day 90±7
Tidsramme: Postoperative day 90±7 (Visit 2)
Incidence of delayed CSF leakage, pseudomeningocele or wound CSF leakage confirmed by MRI or clinical manifestations within 90±7 days post-operation.
Postoperative day 90±7 (Visit 2)
Postoperative Drainage Volume and Drain Indwelling Duration
Tidsramme: Postoperative day 10±5 (Visit 1)
Daily drainage fluid volume from surgical drain and total catheter retention time for patients with postoperative drainage tube placement.
Postoperative day 10±5 (Visit 1)
Incidence of All Adverse Events and Serious Adverse Events
Tidsramme: From surgery to postoperative day 90±7
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.
From surgery to postoperative day 90±7

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medprin Regenerative Medical Technologies Co., Ltd.

Samarbejdspartnere

Xuanwu Hospital, Beijing

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. maj 2024

Primær færdiggørelse (Faktiske)

19. juni 2025

Studieafslutning (Faktiske)

28. juli 2025

Datoer for studieregistrering

Først indsendt

4. august 2026

Først indsendt, der opfyldte QC-kriterier

4. august 2026

Først opslået (Faktiske)

10. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MP-CTP-YYJ2024

Plan for individuelle deltagerdata (IPD)

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INGEN

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