Molecular Characteristics of the Persistent Intestinal Fistulae After Glue Application

November 21, 2013 updated by: Jianan Ren
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

22

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Low-output enterocutaneous fistulas receiving glue application

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fistula closure after glue application
Time Frame: 7 days
No fistula output
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jianan Ren

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

November 11, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (ESTIMATE)

November 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Enterocutaneous Fistulas

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe