Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06324656 |
| Other study ID # |
PRP-PNS |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 21, 2023 |
| Est. completion date |
May 30, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Necmi Kadioglu Hospital |
| Contact |
Mustafa Azizoglu, MD, PhD |
| Phone |
+905447448244 |
| Email |
mdmazizoglu[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The use of local liquid phenol for pilonidal sinus disease was first introduced by Maurica
and Greenwood in 1964. Phenol, also known as carbolic acid, has been proven to be an
effective sclerosing agent for treating pilonidal sinus diseas. Its antiseptic and anesthetic
qualities make it suitable for application in awake patients under local anesthesia. The
treatment of pilonidal sinus diseas in children with crystallized phenol was first published
by Ateş et al in 2018. However, the treatment involving only crystallized phenol can require
numerous sessions, potentially extending the duration of the treatment. IIn this study, the
investigators, investigated whether the application of platelet-rich plasma following
crystallized phenol treatment could accelerate the healing process and reach better outcomes.
This study evaluates the efficacy of PRP as a treatment modality for pilonidal sinus disease
in pediatric patients.
Description:
Upon their arrival at our pilonidal care clinic, patients commenced a regimen of manual
shaving of the gluteal cleft either weekly or bi-weekly. Laser epilation therapy was
initiated at the earliest opportunity, conducted every 6 to 8 weeks, aiming for a hair
reduction of over 90%. For patients presenting with a pilonidal abscess, an initial procedure
of incision and drainage was performed, followed by antibiotic therapy. In the outpatient
clinic, patients were placed in a prone position, and the area was sterilized with a
povidone-iodine solution.
Anaesthesia local: The skin and subcutaneous tissues surrounding the PSD area, including the
sinus openings, receive local anesthesia with 5 ml of lidocaine (20 mg/ml) mixed with
epinephrine (0.0125 mg/ml).
Zone keeps clean: The area surrounding the PSD is thoroughly disinfected with povidone-iodine
solution, covering a minimum area of 20 square centimeters to ensure adequate local
disinfection.
Irrigation with isotonic solution: The wound is washed with sterile isotonic solution.
Zero hair (removing hair and curettage): For sinuses measuring ≤ 3 mm in diameter, dilation
is performed using a mosquito clamp (BH-109, Aesculap®, Center Valley, PA, USA). Hair within
the sinus is removed. After the complete removal of hair from the area, the granulation
tissue is then excised through curettage.
Ointment application around the wound: To prevent skin necrosis and burns, a 0.2%
nitrofurazone (Furacin® Eczacıbası İlaç San, Istanbul, Turkey) ointment is meticulously
applied around the pilonidal sinus area immediately before the CP application, ensuring a
protective barrier and enhancing skin safety.
Gravel-like crystallized phenol application: In this instance, the phenol applied is not in
liquid form; rather, it is in a solid, gravel-like form. CP (BotaFarma İlaç Medikal İtriyat
Kimya San. Tic. Ltd. Şti, Ankara, Turkey) is carefully administered into the cavity via the
orifice, with the precise amount required just sufficient to fill the cavity without causing
any overflow. This step necessitates meticulous attention to ensure the correct dosage and
prevent any potential spillage. Typically, for an average pediatric patient and the size of
the defect encountered, an amount ranging from 4 to 6 grams of phenol is deemed adequate to
effectively treat the area while minimizing risk.
Local re-disinfection prior to PRP injection: Up to this point, all procedures are identical
for both groups. However, the following steps and any subsequent applications are exclusively
for Group 2. The area around the pilonidal sinus should be thoroughly disinfected again with
povidone-iodine (care should be taken to prevent povidone-iodine from entering the sinus
itself). This step is critical because, following this phase, a PRP injection will be
administered into the tissue, necessitating that the skin is properly disinfected to minimize
the risk of infection.
Undergo PRP injection: In Group 2, patients received a PRP injection during the same session
as the CP application. The amount of PRP injected-approximately 1-2 ml, depending on the size
of the pilonidal sinus-was administered around the edges and surrounding area of the wound.
