Role of Autologous Platelet Rich Plasma(PRP) Injection and Platelet Rich Fibrin Glue(PRFG) Interposition for Treatment of Anal Fistula

Assiut University

Status: Not yet enrolling

Conditions: Anal Fistula

Treatments: Other: PRP and PRFG in treatment of anal fistula

Study type: Interventional

Funder types: Other

Identifiers

NCT06092398

PRP and PRFG in anal fistula

Details and patient eligibility

About

To evaluate the autologous platelet rich plasma and platelet rich fibrin glue effect on the treatment of anal fistula

To asses role of platelet rich plasma and platelet rich fibrin glue in decreasing recurrence of perianal fistula

Full description

An anal fistula (AF) is a tunnel connecting the anal canal or rectum (internal opening) with the skin (external opening) around the anus. Patients who have a perianal abscess have symptoms include discomfort, trouble sitting, and pus or blood discharge. Simple and complicated anal fistulas are the two types that exist. A complex fistula is difficult to manage, has a higher risk of recurrence rates, and poses a greater threat to continence after surgery. AF was associated with significant morbidity which is a devastating condition with profound effects on both the physical and psychological health of the patient.

Fibrin glue (also called fibrin sealant) is a surgical formulation used to create a fibrin clot for hemostasis, cartilage repair surgeries or wound healing. It contains separately packaged human fibrinogen and human thrombin. New procedures were published in the scientific literature, each with advantages and disadvantages. According to reports, an effective therapy option is the autologous fibrin glue that is rich in platelets.

PRP began to be used in surgery as a regenerative tissue factor

The tract fistula was cleaned with betadine 10% before PRP and PRFP were applied. Then, 2 ml of PRP was injected around the fistula into the tissue (the penetration depth in injection was 5-6 mm), and 4 ml PRFP was mixed with 1 m thrombin and interpositioned into the tract. 2 ml of PRP was injected around the fistula into the tissue (the penetration depth in injection was 5-6 mm), and 4 ml PRFP was mixed with 1 m thrombin and interpositioned into the tract. The operation time was about 20-30 minutes, the clot formation usually takes about 8 minutes, but the anesthesia was extended to 20 minutes to make sure a complete clot in the place of fistula

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 60 patients with perianal fistula were in the age group between 20 to 60 years old

Exclusion criteria

• Thrombocytopenia
• Patient with rectovaginal fistula
• fistula with chronic cavities
• Acute sepsis and patient were not willing undergo this type of treatment

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

PRP and PRFG in anal fistula

Experimental group

Description:

the tract fistula was cleaned with betadine 10% before PRP and PRFP were applied. Then, 2 ml of PRP was injected around the fistula into the tissue (the penetration depth in injection was 5-6 mm), and 4 ml PRFP was mixed with 1 m thrombin and interpositioned into the tract. 2 ml of PRP was injected around the fistula into the tissue (the penetration depth in injection was 5-6 mm), and 4 ml PRFP was mixed with 1 m thrombin and interpositioned into the tract. The operation time was about 20-30 minutes, the clot formation usually takes about 8 minutes, but the anesthesia was extended to 20 minutes to make sure a complete clot in the place

Treatment:

Other: PRP and PRFG in treatment of anal fistula