A Trial of Absorbable Medical Adhesive for Prevention of CSF Leak

NCT07768553 | Completed Phase 3

• 1 other identifier: MP-CSR-YYJ2021
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 9

Brief Summary

This is a multicenter, randomized, single-blind, positive-controlled, non-inferiority clinical trial designed to evaluate the safety and effectiveness of an absorbable medical adhesive (developed by Guangzhou Maipu Regenerative Medical Technology Co., Ltd.) as an adjunctive method for dural repair in neurosurgery to prevent cerebrospinal fluid (CSF) leakage. A total of 132 subjects (1:1 randomization, 66 in the test group and 66 in the control group) were enrolled across 9 centers in China. The test device is an absorbable medical adhesive composed of polyethylene glycol (PEG) derivatives. The control device is the commercially available absorbable polymeric tissue sealing film (TissuePatchSF, TissueMed Ltd., UK NMPA Registration No. 20163641547). The primary efficacy endpoint is the success rate of postoperative prevention of CSF leakage (assessed at Day 7 ± 3 days post-surgery). Secondary efficacy endpoints include intraoperative CSF leak prevention success rate, postoperative subcutaneous fluid accumulation rate, and scalp incision healing. Safety endpoints include adverse events, serious adverse events, central nervous system infection, and pseudomeningocele. Subjects were followed for 3 months post-surgery. The study was completed in April 2021.

Conditions

Cerebrospinal Fluid Leak

Keywords

Cerebrospinal Fluid Leak

Outcome Measures

Primary Outcomes (1)

• Success Rate of Postoperative Prevention of CSF Leakage

  Success is defined as the absence of cerebrospinal fluid (CSF) leakage at the dural repair site, assessed by imaging (CT/MRI), laboratory tests, and clinical symptoms at Day 7 ± 3 days post-surgery.

  Day 7 ± 3 days post-surgery

Secondary Outcomes (3)

• Intraoperative CSF Leak Prevention Success Rate

  Intraoperative (Day of surgery)

• Postoperative Subcutaneous Fluid Accumulation Rate

  Day 7 ± 3 days post-surgery

• Scalp Incision Healing

  Day 7 ± 3 days post-surgery

Other Outcomes (3)

• Incidence of Adverse Events

  Through study completion (up to 3 months post-surgery)

• Central Nervous System Infection Rate

  Through study completion (up to 3 months post-surgery)

• Pseudomeningocele Rate

  Through study completion (up to 3 months post-surgery)

Study Arms (2)

Experimental: Absorbable Medical Adhesive

EXPERIMENTAL

Subjects undergoing neurosurgical dural repair (including tumor resection or dural repair) who are at risk of or have already developed CSF leakage and require adjunctive sealing. The test device is applied to the dural repair site as an adjunctive sealant.

Device: Absorbable Medical Adhesive

Active Comparator: TissuePatchSF (Absorbable Polymeric Tissue Sealing Film)

ACTIVE COMPARATOR

Subjects undergoing neurosurgical dural repair (including tumor resection or dural repair) who are at risk of or have already developed CSF leakage and require adjunctive sealing. The control device is applied to the dural repair site as an adjunctive sealant per its approved labeling.

Device: TissuePatchSF (Absorbable Polymeric Tissue Sealing Film)

Interventions

Absorbable Medical Adhesive DEVICE

A synthetic absorbable medical adhesive composed of polyethylene glycol (PEG) derivatives (electrophilic and nucleophilic components) that crosslink to form a hydrogel upon mixing. It provides a watertight seal and enhances tissue adhesion through ionic interactions between cationic groups on the nucleophilic component and anions in tissue matrices. The product is biodegradable and has low swelling ratio.Guangzhou Maipu Regenerative Medical Technology Co., Ltd.

Experimental: Absorbable Medical Adhesive

TissuePatchSF (Absorbable Polymeric Tissue Sealing Film) DEVICE

A synthetic absorbable polymeric tissue sealing film indicated as an adjunctive sealant for dural repair in neurosurgery. The product is applied directly to the dural repair site to provide a watertight seal. TissueMed Ltd. (UK) .NMPA Registration No.: 国械注进20163641547

Active Comparator: TissuePatchSF (Absorbable Polymeric Tissue Sealing Film)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and ≤ 75 years, any gender.
• Patients undergoing neurosurgical dural (or spinal dural) repair who are at risk of CSF leakage or who have already developed CSF leakage and require adjunctive repair.
• Patient and/or legal guardian has provided written informed consent.

You may not qualify if:

• Participated in another clinical trial within 1 month prior to screening.
• Body temperature ≥ 37.3°C within 3 days prior to screening.
• Severe diseases of vital organs (heart, liver, kidney) or hematological diseases that would make the patient intolerant to surgery.
• History of severe allergies or severe immunodeficiency.
• Life expectancy \< 3 months.
• Pregnant or breastfeeding women, or women of childbearing age with positive pregnancy test; male or female subjects not using effective contraception or planning to conceive within 3 months after study initiation.
• Poor compliance as judged by the investigator.
• Unable to understand the study description.
• Any other condition deemed unsuitable for participation as judged by the investigator.

Sponsors & Collaborators

• The Second Affiliated Hospital of Air Force Military Medical University: collaborator
• Shenzhen Second People's Hospital: collaborator
• Qinghai People's Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Medprin Regenerative Medical Technologies Co., Ltd.: lead
• General Hospital of Ningxia Medical University: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Second Affiliated Hospital of Shantou University Medical College: collaborator
• Huazhong University of Science and Technology Union Shenzhen Hospital (Shenzhen Nanshan People's Hospital): collaborator

Study Sites (9)

The Second Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Location

Huazhong University of Science and Technology Union Shenzhen Hospital (Shenzhen Nanshan People's Hospital)

Shenzhen, Guangdong, China

Location

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Location

Qinghai Provincial People's Hospital

Xining, Qinghai, China

Location

Tangdu Hospital, Air Force Medical University

Xi'an, Shaanxi, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

MeSH Terms

Conditions

Cerebrospinal Fluid Leak

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 17, 2026
• Study Start: November 13, 2017
• Primary Completion: September 6, 2021
• Study Completion: September 6, 2021
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)