NCT01990833

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1.2 years

First QC Date

November 11, 2013

Last Update Submit

November 21, 2013

Conditions

Enterocutaneous Fistulas

Outcome Measures

Primary Outcomes (1)

  • Fistula closure after glue application

    No fistula output

    7 days

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Low-output enterocutaneous fistulas receiving glue application

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasmas and fistula tissues

MeSH Terms

Conditions

Intestinal Fistula

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice president

Study Record Dates

First Submitted

November 11, 2013

First Posted

November 25, 2013

Study Start

January 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11