Platelet- Rich Plasma Injection (prp)

March 20, 2025 updated by: Mirna Mohamed Elsaid, Mansoura University

Efficacy of Platelet-rich Plasma on Perianal Wound Healing After Anal Fistulotomy: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Fistula-in-ano is an epithelial-lined tract connecting the anal canal to the perianal skin. Most commonly, it affects people in the third to fifth decades of life.

Anal fistula arise spontaneously, when it is referred to as idiopathic or cryptoglandular, or as a result of an underlying pathology, such as inflammatory bowel disease, malignancy, trauma or irradiation.

The majority of anal fistula often occurs following anorectal abscess. An anorectal abscess occurs when an anal gland becomes obstructed, resulting in infection and abscess formation. One-third of patients undergoing incision and drainage of an anorectal abscess will later develop a fistula. Thirty to 70% of patients diagnosed with an anorectal abscess will already have a fistula present on exam.

According to the relation of fistulous track to the sphincter complex, anal fistulas can be classified as simple or complex. Simple anal fistula includes low transsphincteric and intersphincteric fistulas that cross less than 30% of the external sphincter fibers. On the other hand, complex anal fistulas comprise, high transsphincteric fistulas, suprasphincteric, extrasphincteric fistulas, and horseshoe fistulas.

Patients with anal fistula often complain of perianal cellulitis, anorectal pain, pruritus ani, smelly or bloody drainage of pus, and in some cases difficulty controlling bowel movements.

In the long term, it results in significant morbidity through development of recurrent abscesses due to occlusion of the external opening leading to episodes of fever, exquisite perianal pain and discharge, and financial implications through time off work and repeated hospital admissions.

An anorectal fistula is a clinical diagnosis, but imaging is beneficial in determining the course of a fistulous tract or determining its etiology. Imaging studies include endo-anal ultrasound, CT pelvis, CT-fistulography, and MRI of the pelvis. Still, in general, an exam under anesthesia is typically indicated to identify the fistulous tract using a lacrimal probe and methylene blue or hydrogen peroxide.

The treatment for anal fistulae depends on etiology. While the treatment of simple anal fistula is usually straightforward with fistulotomy being recommended as the first line of treatment; the management of more complex cases requires more sophisticated treatments aiming to preserve the anal sphincters and to eradicate the fistulous track. Surgery for complex anal fistula includes the placement of seton, anal advancement flap, laser ablation, fistula plug, and video-assisted anal fistula treatment.

Postoperative pain and delayed wound healing are the main complications following anal surgery associated with poor quality of life.

Platelet-rich plasma (PRP) is an endogenous therapeutic technology that is gaining interest in regenerative medicine due to its potential to stimulate and accelerate tissue healing. PRP is defined as an autologous biological product derived from the patient's blood, and in which after a centrifugation process a plasma fraction is obtained with a platelet concentration higher than that in circulating blood.

Platelets play a crucial role in the wound healing process thanks to their hemostatic function and presence of cytokines and growth factors.

A recent randomized controlled clinical trial investigated the effect of injection of Platelet-rich plasma in patients with open surgery for pilonidal sinus disease in postoperative recovery. It showed that PRP application improves postoperative recovery in that it speeds patients' return to daily activities, reduces their pain scores and increases their quality of life.

No previous studies were designed to investigate the effect of platelet rich plasma injection on perianal wound healing. Our hypothesis entails that platelet rich plasma decrease the complication rate of anal fistula surgery which includes chronic draining wound and pain therefore accelerate the recovery of the patient, return to work and improve the quality of life.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahliya
      • Mansoura, Dakahliya, Egypt, 35511
        • Mansoura University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: platelet rich plasma
will be injected with PLATELT RICH PLASMA in addition to the usual surgery
Procedure: Platelet Rich Plasma
injection of PRP IN PERIANAL WOUNDS AFTER FISTULOTOMY OPERATIONS
No Intervention: control
a control group will be treated with the usual surgery only

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
complete wound healing
Time Frame: from day 1 post operative to maximally 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: from 6 hours postoperative to 2 months
pain score assessed using Visual Analogue Scale; it measures pain intensity; where 0 ('no pain') and 10 ('pain as bad as it could possibly be').
from 6 hours postoperative to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mansoura University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: emad a proffesor
  • Study Director: samy e associate professor
  • Study Director: ahmed h lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRP in perianal wound healing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data is available with corresponding author on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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