Platelet power: new shot may speed anal fistula recovery
NCT ID NCT07248007
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether injecting platelet-rich plasma (PRP) into the wound after fistulotomy surgery for simple anal fistula can speed healing and reduce pain. About 70 adults aged 18-65 with simple low anal fistulas will be randomly assigned to get either standard surgery plus PRP or standard surgery alone. The goal is to see if PRP shortens recovery time and improves comfort.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age18-65years. Both males and females. Clinical diagnosis of simple low anal fistula(confirmed by examination±imaging). Simple fistula is defined as: Fistula affecting less than one third of anal sphincter Fistula willnot affect sphincter function after surgery(no risk for fecal incontinence). All types of low fistula which will not affect anal continence after surgery. Exclusion Criteria: * Complex or high anal fistulas: ( multiple tracts, suprasphincteric, extrasphincteric, or high transsphincteric tracts.) -Underlying diseases that impair healing: (Crohn's disease, ulcerative colitis, tuberculosis, HIV infection, anorectal malignancy) * Hematological disorders: coagulopathy, thrombocytopenia, or platelet dysfunction. * Systemic factors: Uncontrolled diabetes mellitus. Immunosuppressive therapy (e.g., steroids, chemotherapy). Previous surgery for anal fistula (to avoid bias from scar tissue and recurrence).. -Known allergy to any agents used in PRP preparation (rare, e.g., calcium chloride).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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How to take part
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The official record
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