Dural Medical Adhesive for Watertight Sealing in Dural Repair
2026년 8월 4일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
141
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Beijing, 중국
- Peking University Third Hospital
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Beijing, 중국
- Xuanwu Hospital, Capital Medical University
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Guangzhou, 중국
- Nanfang Hospital, Southern Medical University
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Nanchang, 중국
- The First Affiliated Hospital of Nanchang University
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Shenzhen, 중국
- Shenzhen Second People's Hospital
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Xi'an, 중국
- Xi'an Honghui Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Intraoperative Watertight Sealing Success Rate
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative CSF Leakage Rate at Day 10±5
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2024년 5월 29일
기본 완료 (실제)
2025년 6월 19일
연구 완료 (실제)
2025년 7월 28일
연구 등록 날짜
최초 제출
2026년 8월 4일
QC 기준을 충족하는 최초 제출
2026년 8월 4일
처음 게시됨 (실제)
2026년 8월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 4일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- MP-CTP-YYJ2024
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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