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Dural Medical Adhesive for Watertight Sealing in Dural Repair

4 augusti 2026 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

141

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Enhet: 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.
Procedur: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Intraoperative Watertight Sealing Success Rate
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Postoperative CSF Leakage Rate at Day 10±5
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Medprin Regenerative Medical Technologies Co., Ltd.

Samarbetspartners

Xuanwu Hospital, Beijing

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

29 maj 2024

Primärt slutförande (Faktisk)

19 juni 2025

Avslutad studie (Faktisk)

28 juli 2025

Studieregistreringsdatum

Först inskickad

4 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

4 augusti 2026

Första postat (Faktisk)

10 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MP-CTP-YYJ2024

Plan för individuella deltagardata (IPD)

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NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

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