"Feasibility and Safety of the Calcium Alginate Hydrogel Sealant for the Treatment of Cryptoglandular Fistula-in-ano: Phase I/IIa Clinical Trial"

CompletedOBSERVATIONAL
Enrollment

20

Participants

Timeline

Start Date

January 1, 2016

Primary Completion Date

November 30, 2019

Study Completion Date

November 30, 2019

Conditions
Anal Fistula
Interventions
PROCEDURE

Calcium alginate hydrogel

"1. The external and internal fistulous orifice and fistulous tract were explored without applying any product, including hydrogen peroxide or povidone-iodine.~2. The seton was removed and FT cannulation was performed using a needle for cleaning with a gauze impregnated with saline.~3. Calcium chloride was applied through the EFO until it exits through the IFO, and then the IFO was obturated.~4. Alginate was applied, and the pressure at the IFO was stopped, until the alginate solution partial exits through the IFO.~5. The IFO was closed with a 3/0 braided resorbable suture.~6. The EFO was removed with an electric scalpel and closed with a 3/0 braided resorbable suture."

Trial Locations (1)

41013

Sandra Dios Barbeito, Seville

All Listed Sponsors
lead

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

NCT04740086 - "Feasibility and Safety of the Calcium Alginate Hydrogel Sealant for the Treatment of Cryptoglandular Fistula-in-ano: Phase I/IIa Clinical Trial" | Biotech Hunter | Biotech Hunter