Molecular Characteristics of the Persistent Intestinal Fistulae After Glue Application

Enterocutaneous Fistulas Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990833
• Other study ID #: 20120101
• Status: Completed
• Phase: N/A
• First received: November 11, 2013
• Last updated: November 21, 2013
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: November 2013
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Enterocutaneous Fistulas
• Fistula
• Intestinal Fistula

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jianan Ren

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula closure after glue application	No fistula output	7 days	No