Molecular Characteristics of the Persistent Intestinal Fistulae After Glue Application

NCT ID: NCT01990833

Last Updated: 2013-11-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-03-31

Brief Summary

For non-healing ulcers, abnormal periods of wound healing processes: inflammation, proliferation and remodelling, are believed to lead to chronic wounds. As a chronic "stalled" wound, investigators hypothesized that these glue-assisted closure (GAC)-failed enterocutaneous fistula (ECF) might have a prolonged inflammatory phase modulated by excessive pro-inflammatory cytokines or proteases. The aim of this study was to analyze the chemicals in ECF wounds in order to determine patients' condition and fitness for GAC.

Conditions

Enterocutaneous Fistulas

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• above 18 years old;
• single tubular (tract length >2 cm) ECF;
• low output volume (<200 ml/24h);

Exclusion Criteria

• fistulas of cancer-infiltrated;
• associated abscess;
• foreign bodies;
• distal bowel obstruction;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jianan Ren

OTHER

Sponsor Role: lead

Responsible Party

Jianan Ren

Vice president

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

20120101

Identifier Type: -

Identifier Source: org_study_id