Wound HealingprpNCT06887166
Platelet- Rich Plasma Injection
A study testing Platelet Rich Plasma in people with Wound Healing and Anal Fistula, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Wound Healing, Anal Fistula
- What is being tested?
- Platelet Rich Plasma
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jul 2023to 5 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Wound Healing, Anal Fistula
- Being tested
- Platelet Rich Plasma
- Keywords
- prp, wound healing, perianal wounds
- Medical subject headings
- Rectal Fistula, Insomnia, Fatal Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaProcedure or surgery
injection of PRP IN PERIANAL WOUNDS AFTER FISTULOTOMY OPERATIONS
| Study group | Role | What they receive |
|---|---|---|
| platelet rich plasma | Active comparator | will be injected with PLATELT RICH PLASMA in addition to the usual surgery Receives: Procedure: Platelet Rich Plasma |
| control | No intervention | a control group will be treated with the usual surgery only |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete wound healing
duration in days required to achieve complete healing of the anal wound in both groups on postoperative follow-up
Measured: from day 1 post operative to maximally 6 months
Secondary outcomes (1)
pain score
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').
Measured: from 6 hours postoperative to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start14 Jul 2023
- Primary completion14 Jul 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirna Mohamed Elsaid, Mansoura University
- Investigators
- emad a proffesor, Study chairsamy e associate professor, Study directorahmed h lecturer, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887166
- Sponsor's protocol ID
- PRP in perianal wound healing
- Acronym
- prp
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data is available with corresponding author on request
Publications
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.
PubMed 34670534
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelet-rich Plasma on Perianal Wound Healing After Anal Fistulotomy: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06887166
- Acronym / sponsor ID
- prp / PRP in perianal wound healing
- Conditions
- Wound Healing, Anal Fistula
- Keywords
- prp, wound healing, perianal wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 14 Jul 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platelet rich plasma | Active comparator | Procedure: Platelet Rich Plasmawill be injected with PLATELT RICH PLASMA in addition to the usual surgery |
| control | No intervention | –a control group will be treated with the usual surgery only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich Plasmainjection of PRP IN PERIANAL WOUNDS AFTER FISTULOTOMY OPERATIONS | Procedure or surgery | platelet rich plasma |
Primary outcome
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
1 secondary outcome
pain score
Time frame: from 6 hours postoperative to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Background: PubMed 34670534Boztug 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.
- Platelet-rich plasma treatment improves postoperative recovery in patients with pilonidal sinus disease: a randomized controlled clinical trialLink provided by the sponsor.
- Individual participant dataSharing planned: No. data is available with corresponding author on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
emad a proffesor study chair
samy e associate professor study director
ahmed h lecturer study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma in people with Wound Healing and Anal Fistula, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete wound healing (time frame: from day 1 post operative to maximally 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06887166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.