A Trial of Absorbable Medical Adhesive for Prevention of CSF Leak

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

Interventions

DEVICE

Absorbable Medical Adhesive

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.

DEVICE

TissuePatchSF (Absorbable Polymeric Tissue Sealing Film)

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

Sponsors & Collaborators

• The Second Affiliated Hospital of Air Force Military Medical University

  collaborator OTHER

• Second Affiliated Hospital of Shantou University Medical College

  collaborator OTHER

• General Hospital of Ningxia Medical University

  collaborator OTHER

• Shenzhen Second People's Hospital

  collaborator OTHER

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

  collaborator UNKNOWN

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• Qinghai People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Medprin Regenerative Medical Technologies Co., Ltd.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-13

Primary Completion

2021-09-06

Completion

2021-09-06

Countries

• China

Study Locations