Platelet- Rich Plasma Injection

NCT06887166 | Completed DMC

• 1 other identifier: PRP in perianal wound healing
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study aims to investigate the effect of injection of platelet rich plasma on the postoperative outcome of perianal wound after anal fistula surgery in terms of healing time, reduction in wound size, pain score , and therefore quality of patients' life.

Conditions

Wound Healing; Anal Fistula

Keywords

prp; wound healing; perianal wounds

Outcome Measures

Primary Outcomes (1)

• complete wound healing

  duration in days required to achieve complete healing of the anal wound in both groups on postoperative follow-up

  from day 1 post operative to maximally 6 months

Secondary Outcomes (1)

• pain score

  from 6 hours postoperative to 2 months

Study Arms (2)

platelet rich plasma

ACTIVE COMPARATOR

will be injected with PLATELT RICH PLASMA in addition to the usual surgery

Procedure: Platelet Rich Plasma

control

NO INTERVENTION

a control group will be treated with the usual surgery only

Interventions

Platelet Rich Plasma PROCEDURE

injection of PRP IN PERIANAL WOUNDS AFTER FISTULOTOMY OPERATIONS

platelet rich plasma

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genders
• Aging between 18-65 years
• Presented by simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 30% of external anal sphincter fibers)

You may not qualify if:

• Patients with associated anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases.
• Patients on long-acting corticosteroids or immunosuppressive drugs
• Patients having connective tissue diseases
• Patients with complex anal fistula.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahliya, 35511, Egypt

Location

Related Publications (1)

• Boztug CY, Karaagac Akyol T, Benlice C, Koc MA, Doganay Erdogan B, Ozcebe OI, Kuzu MA, Akyol C. Platelet-rich plasma treatment improves postoperative recovery in patients with pilonidal sinus disease: a randomized controlled clinical trial. BMC Surg. 2021 Oct 21;21(1):373. doi: 10.1186/s12893-021-01370-5.

  PMID: 34670534 BACKGROUND

Related Links

• Platelet-rich plasma treatment improves postoperative recovery in patients with pilonidal sinus disease: a randomized controlled clinical trial

MeSH Terms

Conditions

Rectal Fistula; Insomnia, Fatal Familial

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Prion Diseases; Central Nervous System Infections; Infections; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• emad a proffesor

  STUDY CHAIR

• samy e associate professor

  STUDY DIRECTOR

• ahmed h lecturer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of general surgery

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: July 14, 2023
• Primary Completion: July 14, 2024
• Study Completion: August 5, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)