Study to determine how safe and effective is a therapy for the treatment of anal fistula, compared with another treatment that is considered of choice for this disease

PHASE III CLINICAL TRIAL, single-center, randomized, double blind IN TWO GROUPS PARALLELS TO COMPARE THE EFFICACY AND SAFETY OF RICH PLASMA GROWTH FACTORS (PRGF) IN FRONT OF fibrin glue (TISSUCOL ®) FOR SEALING ANAL AND CRIPTOGLANDULAR FISTULA AFTER 48 WEEKS

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002579-16-ES

Enrollment

104

Registered

2014-11-04

Start date

2014-12-09

Completion date

Unknown

Last updated

2015-03-02

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

Conditions

Anal and criptoglandular fistula

Interventions

Product Name: PLATELET RICH FACTORS Pharmaceutical Form: Rectal solution INN or Proposed INN: PRGF Other descriptive name: PLATELETS Concentration unit: % percent Concentration type: equal Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Signed consent Older than 18 years Cryptoglandular anal fistulas. There may be at most 3 external orifices open and a maximum one inner hole. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 104 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Filed or coexisting undrained collections. ASA IV History of radiation therapy in the perineal area No internal opening Pregnant (IF POSSIBLE PREGNANCY PREGNANCY TEST DO) immunosuppression Patients with active neoplasia or neoplasia has had a less than a year. HIV Simple fistula (submucosal / subcutaneous / low intersphincteric)

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy and safety of PRGF as sealant for the treatment of anal fistula cryptoglandular against fibrin, which is the current gold standard treatment for sealing anal fistulas.;Secondary Objective: - To assess the clinical response are wholly or partially, at each visit and at the end of the trial, compared to baseline data. - Assess the time to clinical remission wholly or partially defined at each visit and at the end of the trial, compared to baseline data. - To assess the radiological response by endoanal ultrasound at the end of the trial compared to baseline ultrasound data. - Assess changes in quality of life, assessed using the Quality of Life Questionnaire SF36 at each visit and at the end of the trial, compared to baseline data. Safety evaluation;Primary end point(s): The fistula is considered cured when the external fistula orifice, are closed and / or does not drain after compression finger. Persistence of symptoms after three months of surgery: recurrence and / or failure of treatment is considered.;Timepoint(s) of evaluation of this end point: At three, six, and twelve months after treatment	—

Measure

Time frame

Main Objective: To evaluate the efficacy and safety of PRGF as sealant for the treatment of anal fistula cryptoglandular against fibrin, which is the current gold standard treatment for sealing anal fistulas.;Secondary Objective: - To assess the clinical response are wholly or partially, at each visit and at the end of the trial, compared to baseline data. - Assess the time to clinical remission wholly or partially defined at each visit and at the end of the trial, compared to baseline data. - To assess the radiological response by endoanal ultrasound at the end of the trial compared to baseline ultrasound data. - Assess changes in quality of life, assessed using the Quality of Life Questionnaire SF36 at each visit and at the end of the trial, compared to baseline data. Safety evaluation;Primary end point(s): The fistula is considered cured when the external fistula orifice, are closed and / or does not drain after compression finger. Persistence of symptoms after three months of surgery: recurrence and / or failure of treatment is considered.;Timepoint(s) of evaluation of this end point: At three, six, and twelve months after treatment

—

Secondary

Measure	Time frame
Secondary end point(s): The safety assessment will be part of the secondary endpoints and include possible adverse events PRGF measured by recording adverse events reported during the study and clinical findings of the physical examination. The evaluation will also consider the evaluation of fecal incontinence.;Timepoint(s) of evaluation of this end point: At three, six, and twelve months after treatment	—

Measure

Time frame

Secondary end point(s): The safety assessment will be part of the secondary endpoints and include possible adverse events PRGF measured by recording adverse events reported during the study and clinical findings of the physical examination. The evaluation will also consider the evaluation of fecal incontinence.;Timepoint(s) of evaluation of this end point: At three, six, and twelve months after treatment

—

Countries

Spain

Contacts

Public ContactFUNDACION GESTION INVESTIGACION SEV

C. HOSPITALARIO VIRGEN DEL ROCIO

mariavmaestre@gmail.com+34955012292

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026