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

NCT ID: NCT07248007

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-11-30

Brief 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% .

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

Conditions

Simple Anal Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRP injection

a group of patients with simple anal fistula that will be treated with PRP following fistulotomy

Group Type: ACTIVE_COMPARATOR

PRP injection

Intervention Type: PROCEDURE

Injection of PRP after fistulotomy in simple low anal fistula

Non PRP group

the other group that will be treated with fistulotomy only without PRP

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PRP injection

Injection of PRP after fistulotomy in simple low anal fistula

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Osama Ahmed

Demonstrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohammed Osama, Resident

Role: CONTACT

zezoosama99@gmail.com

01110554779

Other Identifiers

RPRFISULOTOMY

Identifier Type: -

Identifier Source: org_study_id