Dural Medical Adhesive for Watertight Sealing in Dural Repair
2026年8月4日 更新者：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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
141
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Beijing、中国
- Peking University Third Hospital
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Beijing、中国
- Xuanwu Hospital, Capital Medical University
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Guangzhou、中国
- Nanfang Hospital, Southern Medical University
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Nanchang、中国
- The First Affiliated Hospital of Nanchang University
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Shenzhen、中国
- Shenzhen Second People's Hospital
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Xi'an、中国
- Xi'an Honghui Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Intraoperative Watertight Sealing Success Rate
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postoperative CSF Leakage Rate at Day 10±5
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年5月29日
一次修了 (実際)
2025年6月19日
研究の完了 (実際)
2025年7月28日
試験登録日
最初に提出
2026年8月4日
QC基準を満たした最初の提出物
2026年8月4日
最初の投稿 (実際)
2026年8月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月10日
QC基準を満たした最後の更新が送信されました
2026年8月4日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- MP-CTP-YYJ2024
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いいえ
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