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Glue Sealing for Patients With Low-Output ECFs

NCT01672593 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-03-11

No results posted yet for this study

Summary

Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output ECFs. The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG) and a commercially available fibrin sealant Bioseal® in the management of patients with low-output volume ECFs.

Conditions

  • Low-output External Gastrointestinal Fistula

Interventions

PROCEDURE

Endoscopy exploration and glue application

A forward-viewing fistula-fiberscope (EndoView, Outai Medical Equipment, Shanghai, China), with 15cm length and 5mm width of fiber optical wire, was inserted into the fistula tract to accomplish endoscopic visualization. Briefly, the fistula-fiberscope assisted procedure was carried out percutaneously, allowing the exposure of internal hole and the whole tracts, followed by insertion of this catheter with distal mixing device. Upon injection, two components, fibrinogen and thrombin, were mixed together in the mixing reservoir and yield a gelatin-like glue. This procedure was repeated in patients up to 3 times within 14-day FG treatment period.

DRUG

Anti-Bacterial Agents

Antibacterial therapy was given to patients with signs of systemic sepsis or local inflammation with pain.

DIETARY_SUPPLEMENT

Nutrition support

Nutritional replacement and bowel rest via enteral or parenteral nutrition.

PROCEDURE

PRFG preparation

As described in our previous work, platelet-rich cryoprecipitate and thrombin were obtained from 300-400ml whole blood of each patient enrolled in the PRFG group and then frozen at -20°C for storage.

Sponsors & Collaborators

  • Jinling Hospital, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01672593 on ClinicalTrials.gov