Effect of Platelet-Rich Plasma Injection on Wound Healing After Fistulotomy for Simple Anal Fistula Randomized Controlled Trial (RCT) (PRPIWHAFSAFRCT)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Simple Anal Fistula
• Intervention / Treatment: Procedure: PRP injection

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mohammed Osama, Resident; Phone Number: 01110554779; Email: zezoosama99@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PRP injection; a group of patients with simple anal fistula that will be treated with PRP following fistulotomy	Procedure: PRP injection; Injection of PRP after fistulotomy in simple low anal fistula
No Intervention: Non PRP group; the other group that will be treated with fistulotomy only without PRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	messure the improvement of operative time between the PRP group and the non PRP group	intra operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain	messure the improvement of post operative pain between the 2 groups using the VIsual Analogue Scale (VAS) score	12 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: anal fistula
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Digestive System Fistula; Fistula; Intestinal Fistula; Pathological Conditions, Signs and Symptoms; Rectal Fistula
• Other Study ID Numbers: RPRFISULOTOMY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No