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

NCT ID: NCT06092398

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2028-04-30

Brief Summary

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

Detailed 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

Conditions

Anal Fistula

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PRP and PRFG in anal fistula

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

Group Type: EXPERIMENTAL

PRP and PRFG in treatment of anal fistula

Intervention Type: OTHER

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

Interventions

PRP and PRFG in treatment of anal fistula

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Hassan Thabet Ahmed

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

maha atwa, PHD

Role: STUDY_CHAIR

Assiut University

Central Contacts

marwa hassan thabet, master

Role: CONTACT

meromoro1010@gmail.com

01004748373

mariam Ezzat, MD

Role: CONTACT

References

Abdollahi, Abbas, Elaheh Emadi, and Dariyoush Hamidi Alamdary.

Reference Type: BACKGROUND

Yeung JM, Simpson JA, Tang SW, Armitage NC, Maxwell-Armstrong C. Fibrin glue for the treatment of fistulae in ano--a method worth sticking to? Colorectal Dis. 2010 Apr;12(4):363-6. doi: 10.1111/j.1463-1318.2009.01801.x. Epub 2009 Feb 7.

Reference Type: BACKGROUND

PMID: 19220380 (View on PubMed)

Ji, Lijiang, et al.

Reference Type: RESULT

Other Identifiers

PRP and PRFG in anal fistula

Identifier Type: -

Identifier Source: org_study_id