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Glue Application in the Treatment of Low-Output Fistulas

Information source: Jinling Hospital, China
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Low-output External Gastrointestinal Fistula

Intervention: Endoscopy exploration and glue application (Procedure); Endoscopy exploration (Procedure); Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin) (Drug); Nutrition support (Dietary Supplement)

Phase: N/A

Status: Recruiting

Sponsored by: Jinling Hospital, China

Official(s) and/or principal investigator(s):
Jianan Ren, MD, Principal Investigator, Affiliation: Jinling Hospital, China

Overall contact:
Jianan Ren, MD, Phone: 862580860108, Email: jiananr@gmail.com

Summary

Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output enterocutaneous fistulas (ECFs). The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG), commercial fibrin glue, and control therapy in the management of patients with low-output volume ECFs.

Clinical Details

Official title: A Randomized Controlled Trial to Evaluate Fibrin Glue Application in the Treatment of Low-Output Enterocutaneous Fistulas

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Closure rates up to 14 days

Secondary outcome: Number of adverse events

Detailed description:

- This is a prospective, randomized, multi-centered study clinical, safety and economic

outcome of ECFs patients.

- Subjects are randomized to one of 3 groups:

- Group 1: Autologous PRFG-treatment [PRFG + Standard of care (SOC)]

- Group 2: Commercial FG-treatment [FG + Standard of care (SOC)]

- Group 3: Control (SOC only)

- Study will include three phases:

- Phase 1: Screening, consent and enrollment

- Phase 2: Patients will receive either PRFG, commercial FG, or SOC only for 14 days

- Phase 3: Follow up: for patients with closed fistula within 14 days, we will

follow up them for 6 months. For patients whose fistulas were still open will be treated with other therapeutic option and follow up for 6 months after closure.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with a single tubular ECF

- Low output volume (<200 ml/24h)

- Tract length >2cm

- Tract diameter < 1cm

Exclusion Criteria:

- Cancer-infiltrated fistula

- Abscess

- Foreign bodies

- Distal bowel obstruction

- Inflammatory Bowel Disease

Locations and Contacts

Jianan Ren, MD, Phone: 862580860108, Email: jiananr@gmail.com

Jinling Hospital, Nanjing, Jiangsu 210002, China; Recruiting
Jianan Ren, MD, Phone: 862580860108, Email: Jiananr@gmail.com
Additional Information

Starting date: March 2014
Last updated: June 9, 2015

Page last updated: August 23, 2015

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