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Completed

NCT Number: NCT07768553

A Trial of Absorbable Medical Adhesive for Prevention of CSF Leak

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.

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Key information

Conditions

Cerebrospinal Fluid Leak Craniocerebral Trauma Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Second Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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

Primary outcomes

  1. Success Rate of Postoperative Prevention of CSF Leakage

    Time frame: Day 7 ± 3 days post-surgery

    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.

Secondary outcomes

  1. Intraoperative CSF Leak Prevention Success Rate

    Time frame: Intraoperative (Day of surgery)

    Success is defined as absence of CSF leakage at the repair site after application of the test/control device, assessed by Valsalva maneuver or other effective methods.

  2. Postoperative Subcutaneous Fluid Accumulation Rate

    Time frame: Day 7 ± 3 days post-surgery

    Presence of subcutaneous fluid accumulation assessed by imaging (CT/MRI), laboratory tests, or clinical examination (e.g., aspiration) at Day 7 ± 3 days post-surgery.

  3. Scalp Incision Healing

    Time frame: Day 7 ± 3 days post-surgery

    Assessment of surgical wound healing based on clinical examination at Day 7 ± 3 days post-surgery.

Other outcomes

  1. Incidence of Adverse Events

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

    All adverse events, including device-related AEs, serious AEs, and device-related SAEs.

  2. Central Nervous System Infection Rate

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

    Incidence of CNS infection as diagnosed by clinical and laboratory findings.

  3. Pseudomeningocele Rate

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

    Incidence of pseudomeningocele diagnosed by imaging (CT/MRI) and clinical examination.

Sponsors and collaborators

Lead sponsor

Medprin Regenerative Medical Technologies Co., Ltd.

Industry

Collaborators

  • General Hospital of Ningxia Medical University
  • Huazhong University of Science and Technology Union Shenzhen Hospital (Shenzhen Nanshan People's Hospital)
  • Qinghai People's Hospital
  • Second Affiliated Hospital of Nanchang University
  • Second Affiliated Hospital of Shantou University Medical College
  • Shenzhen Second People's Hospital
  • The Affiliated Hospital of Qingdao University
  • The First Affiliated Hospital of Nanchang University
  • The Second Affiliated Hospital of Air Force Military Medical University

Registry information

Official study title

A Multicenter, Randomized, Single-Blind, Positive-Controlled, Non-Inferiority Clinical Trial of Absorbable Medical Adhesive as an Adjunctive Method for Dural Repair in Neurosurgery to Prevent Cerebrospinal Fluid Leak

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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