Enterocutaneous fistula repair using the Biodesign enterocutaneous fistula plug ( Cook Medical)

Enterocutaneous fistula repair using the Biodesign enterocutaneous fistula plug ( Cook Medical) - ECF repair with a Biodesign fistula plug

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38559

Enrollment

Registered

2013-09-18

Start date

2013-05-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

abnormal connection between gut and skin Enterocutaneous fistula

Interventions

Percutaneous placement of Biodesign plug ( Cook Medical) in enterocutaneous fistula according to protocol

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: A longstanding ( more than 6 months ) therapy-resistant ( therapy according to AVL standard) low-output ( less than 200 ml/ 24 hours) ECF. Size of the ECF : 2/6-mm diameter, length less than 18 cm.

Exclusion criteria

Exclusion criteria: Sensitivity to porcine materials. An abscess cavity that is not sufficiently drained An abscess cavity that is immediately adjacent to the internal fistula opening

Design outcomes

Primary

Measure	Time frame
Technical feasibility of the treatment protocol, including: to determine the feasibility, tolerance and primary technical success rate of the Enterocutaneous fistula repair using the Biodesign enterocutaneous fistula plug ( Cook Medical)	—

Secondary

Measure	Time frame
The secondary objective will be to evaluate the longterm success ( after 3, 6 and 12 months): permanent closure ( non-production, skin healing) of the fistula.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)