Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202311570350354 Date of Approval: 28/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of The Effect of Platelet Rich Plasma on the healing of the lay open surgically repaired sacrococcygeal pilonidal sinus.
Official scientific title Evaluation of The Effect of Platelet Rich Plasma on the healing of the lay open surgically repaired sacrococcygeal pilonidal sinus.
Brief summary describing the background and objectives of the trial Background: Pilonidal sinus disease indicates a disease consisting of hair-containing sinus usually found in the sacrococcygeal area. The two main surgical methods of pilonidal sinus disease include excision with primary closure/flap repair or excision of the sinus with healing by secondary intent. Wounds left open to heal by secondary intent remain extremely common due to their association with reduced risk of recurrence,however, it is associated with prolonged healing times. Aim of the work: This study was done for evaluation of the role of PRP in accelerating wound healing of fourty patients with pilonidal sinus disease for whome lay-open excision of pilonidal sinus disease with secondary healing method was done
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) PRP in pilinidal sinus
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2020
Actual trial start date 01/10/2019
Anticipated date of last follow up 12/09/2021
Actual Last follow-up date 12/09/2021
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Active, not recruiting
Publication URL https://journals.lww.com/aamj/pages/default.aspx
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Platelet Rich Plasma injection in lay open surgically repaired sacrococcygeal pilonidal sinus. The first injection was performed right after surgery (in which PRP was injected up to 13 mm deep into the wound area (0.1 cc/cm2)). On postoperative days 3, 7 and 14, patients were scheduled for injection visits. Fresh frozen plasma was injected into the wound to a depth of 13 mm via the granulation tissue under the skin using a 0.1 cc/cm2 insulin needle as soon as possible for each injection (the entire process took less than 30 seconds), and the leftover PRP was then injected into the wound. The surface was then covered with sterile non-allergenic latex to prevent PRP leakage for 24 hours. After 24 hours, the latex covering was taken off, and the usual dressing was put on. 2 weeks 25cc of venous blood was drawn from the patient using a 30mL syringe containing 3mL anticoagulant: sodium citrate 3.8% then the blood was shaken gently 4 times. The blood was collected in seven 4 ml clean vacutainer tubes.The citrated blood was centrifuged at1700 rpm at room temperature for 15 minutes., separating red blood cells at the bottom with plasma at the top and a “buffy coat” in between. The plasma and the buffy coat were aspirated from every test tube into a syringe and exchanged to another tube then centrifuged again at 3000 rpm for 10 min at room temperature resulting in two layers of plasma: the upper layer consists of platelet-poor plasma (PPP); and the lower layer consists of platelet-rich plasma (PRP). The PPP was carfully aspirated, to separate it from the PRP 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria for surgical treatment included patients who presented with sacrococcygeal pilonidal sinus even recurrent cases. Exclusion criteria included patients who presented with acute pilonidal abscess, uncontrolled diabetes mellitus, anemia or thrombocytopenia (on anticoagulant treatment) and also patients who have pits below the coccyx. Adult: 19 Year-44 Year 19 Year(s) 44 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/10/2020 Al Azhar ethical board
Ethics Committee Address
Street address City Postal code Country
Al saeidy street new damietta 7952567 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome shortens the healing time and post-operative pain associated with pilonidal wounds following surgery. 6 weeks after operation
Secondary Outcome also the time needed to resume work or daily activities, and complications are decreased. PRP therapy would therefore probably lessen the financial burden related to lay-open excision of pilonidal sinus illness. 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Azhar university Faculty of medicine University hospital Damietta Al sinaeia New damietta 7952567 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no alseedy street new damietta 7952567 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hazem Ahmed Megahed Al saedy street new damietta 7952567 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Lamiaa Zakaria Elmoursi alhawaary street Al mansoura 35511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hazem Megahed doctor_hazem_m@yahoo.com 00966569023468 al saedy street
City Postal code Country Position/Affiliation
new damietta 7952567 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Lamiaa Elmoursi dr.lamiaa.3@gmail.com 00966565513823 Al hawaary street
City Postal code Country Position/Affiliation
Al mansoura 35511 Egypt Consultant
Role Name Email Phone Street address
Public Enquiries Youssif Ali Youssif.Gimsct@gmail.com 00201005190565 Alsaedy street
City Postal code Country Position/Affiliation
new damietta 7952567 Egypt doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Results: The PRP group (B) experienced accelerated healing, which was identified on week 1 (day 7) and resulted in a significant difference. Week 2 (day 14), Week 3 (day 21), Week 4 (day 28), and Week 5 (day 35) all revealed a very significant difference. At week 6 (day 42) it becomes significant again. Statistical Analysis Plan 6-weeks https://journals.lww.com/aamj/pages/default.aspx
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://journals.lww.com/aamj/pages/default.aspx Yes 19/11/2023 19/11/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 19/11/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks -
Changes to trial information