Simple Anal FistulaPhase 1PRPIWHAFSAFRCTNCT07248007
Effect of Platelet-Rich Plasma Injection on Wound Healing After Fistulotomy for Simple Anal Fistula Randomized Controlled Trial (RCT)
A Phase 1 study testing PRP injection in people with Simple Anal Fistula, run by Assiut University.
Trial summary
Anal fistula is a common benign anorectal condition characterized by an abnormal tract between the anal canal and perianal skin, often resulting from cryptoglandular infection. Surgical fistulotomy remains the standard treatment for simple low anal fistulas, with success rates exceeding 90% . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Simple Anal Fistula
- What is being tested?
- PRP injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 30 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Anal fistula is a common benign anorectal condition characterized by an abnormal tract between the anal canal and perianal skin, often resulting from cryptoglandular infection. Surgical fistulotomy remains the standard treatment for simple low anal fistulas, with success rates exceeding 90% .
However,wound healing following fistulotomy can be prolonged,ranging from 6-10 weeks,which affects patient comfort, quality of life, and return to normal activity (1,2).
Read more
After a fistulotomy, the tract is laid open, leaving behind a raw wound extending from the anal canal to the perianal skin.Traditionally,this wound is left open to heal by secondary intention(granulation and epithelialization).
In marsupialization, the cut wound edges (the mucosa and anoderm/skin) are sutured to the wound base.Thismakesthewoundshallowerandkeepsitopenfordrainage.Itpreventsadeepcavitythat would otherwise take longer to granulate and epithelialize.
Marsupialization of the wound edges has been introduced as a modification of standard fistulotomy to improve healing outcomes. Several randomized trials have shown that marsupialization accelerates wound healing (by 1-4 weeks) and preserves sphincter function better compared to leaving the wound open, without increasing recurrence or complications (3,4,5).
Read the detailed description
Platelet-rich plasma(PRP) has been widely investigated and applied in several surgical fields because of its ability to promote tissue regeneration and accelerate healing. In orthopedic surgery, PRP has been used to enhance bone and tendon healing, particularly in the managementofchronictendinopathiesandfractures.Inplastic and reconstructive surgery,it has been applied to improve graft take, flap survival, and cosmetic outcomes in wound coverage.In maxillofacial and dental surgery, PRP has shown benefits in bone regeneration, implant integration, and periodontal healing. More recently, colorectal and general surgery have explored PRP for difficult-to-heal wounds, including anal fistula, where it has been demonstrated to shorten healing time and reduce recurrence rates
- Conditions
- Simple Anal Fistula
- Being tested
- PRP injection
- Keywords
- anal fistula
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injectionProcedure or surgery
Injection of PRP after fistulotomy in simple low anal fistula
| Study group | Role | What they receive |
|---|---|---|
| PRP injection | Active comparator | a group of patients with simple anal fistula that will be treated with PRP following fistulotomy Receives: Procedure: PRP injection |
| Non PRP group | No intervention | the other group that will be treated with fistulotomy only without PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
messure the improvement of operative time between the PRP group and the non PRP group
Measured: intra operative
Secondary outcomes (1)
Post operative pain
messure the improvement of post operative pain between the 2 groups using the VIsual Analogue Scale (VAS) score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simple Anal FistulaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparison between 2 groups of patients with simple anal fistula one group use PRP with fistulotomy in treatment and the other group only do fistulotomy
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Osama Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248007
- Sponsor's protocol ID
- RPRFISULOTOMY
- Acronym
- PRPIWHAFSAFRCT
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Platelet-Rich Plasma Injection on Wound Healing After Fistulotomy for Simple Anal Fistula Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT07248007
- Acronym / sponsor ID
- PRPIWHAFSAFRCT / RPRFISULOTOMY
- Conditions
- Simple Anal Fistula
- Keywords
- anal fistula
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anal fistula is a common benign anorectal condition characterized by an abnormal tract between the anal canal and perianal skin, often resulting from cryptoglandular infection. Surgical fistulotomy remains the standard treatment for simple low anal fistulas, with success rates exceeding 90% .
However,wound healing following fistulotomy can be prolonged,ranging from 6-10 weeks,which affects patient comfort, quality of life, and return to normal activity (1,2).
After a fistulotomy, the tract is laid open, leaving behind a raw wound extending from the anal canal to the perianal skin.Traditionally,this wound is left open to heal by secondary intention(granulation and epithelialization).
In marsupialization, the cut wound edges (the mucosa and anoderm/skin) are sutured to the wound base.Thismakesthewoundshallowerandkeepsitopenfordrainage.Itpreventsadeepcavitythat would otherwise take longer to granulate and epithelialize.
Marsupialization of the wound edges has been introduced as a modification of standard fistulotomy to improve healing outcomes. Several randomized trials have shown that marsupialization accelerates wound healing (by 1-4 weeks) and preserves sphincter function better compared to leaving the wound open, without increasing recurrence or complications (3,4,5).
Detailed description
Platelet-rich plasma(PRP) has been widely investigated and applied in several surgical fields because of its ability to promote tissue regeneration and accelerate healing. In orthopedic surgery, PRP has been used to enhance bone and tendon healing, particularly in the managementofchronictendinopathiesandfractures.Inplastic and reconstructive surgery,it has been applied to improve graft take, flap survival, and cosmetic outcomes in wound coverage.In maxillofacial and dental surgery, PRP has shown benefits in bone regeneration, implant integration, and periodontal healing. More recently, colorectal and general surgery have explored PRP for difficult-to-heal wounds, including anal fistula, where it has been demonstrated to shorten healing time and reduce recurrence rates
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparison between 2 groups of patients with simple anal fistula one group use PRP with fistulotomy in treatment and the other group only do fistulotomy
| Arm | Type | Receives |
|---|---|---|
| PRP injection | Active comparator | Procedure: PRP injectiona group of patients with simple anal fistula that will be treated with PRP following fistulotomy |
| Non PRP group | No intervention | –the other group that will be treated with fistulotomy only without PRP |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age18-65years. Both males and females. Clinical diagnosis of simple low anal fistula(confirmed by examination±imaging).
- 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.
Key exclusion criteria (6 listed)
- 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)..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP injectionInjection of PRP after fistulotomy in simple low anal fistula | Procedure or surgery | PRP injection |
Primary outcome
Operative time
Time frame: intra operative
messure the improvement of operative time between the PRP group and the non PRP group
1 secondary outcome
Post operative pain
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRP injection in people with Simple Anal Fistula, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Osama, Resident (01110554779, zezoosama99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: intra operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.