NCT07248007

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	PRP injection	Injection of PRP after fistulotomy in simple low anal fistula

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-01
• Completion: 2027-11-30
• First posted: 2025-11-25
• Last updated: 2025-11-25