Autologous Fibrin Glues for Fistulas Closure

What Was Tested

In this phase 1 trial, researchers set out to test Octreotide.

Adjuvant use of fibrin glue in the fistula tract may promote healing in low-output enterocutaneous fistulas.

However, there are only few studies that report autologous glue application in a larger patient group or clinical-controlled studies in this setting.

It had two arms (groups): conservative therapy (sham comparator) and Application of autologous PRFG (active comparator).

Conservative therapy includes orrection of electrolytic disturbances, suppression of gastric/intestinal secretion with octreotide, nutritional support.

The registry classes the interventions as drug and procedure.

More on the Plan

The sudden appearance of intestinal contents draining from an abdominal incision is an emotionally devastating experience for both patients and surgeons.

Sufficient time should be allotted for the ECF to heal with conservative treatment, which also results in long-term discomfort.

Adjuvant use of fibrin glue (FG) in the fistula tract may promote healing in low-output ECF.

Containing high concentrations of human fibrinogen and thrombin, FG have been used extensively in many surgical fields as a biological adhesive system for tissue adhesion or hemostasis.

Who Took Part

The registry lists 122 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Older than 18 years. Presence of one or more fistulas.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: failure to meet inclusion criteria; mental handicap; extreme thinness.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2008-01 with completion listed for 2012-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): counting time from enrollment or glue application to fistula closure or healing (d) (time frame: 1-90 days).

It also tracked 1 secondary outcome, for example counting time from enrollment or glue application to enteral intake (d).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Octreotide in 122 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.