- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07567586
The Role of Platelet-rich Plasma Local Injection as Treatment in Improvement of Pilonidal Sinus Surgery Outcomes
Assessment of the Role of Platelet-rich Plasma Local Injection as an Additional Treatment in Improvement of Pilonidal Sinus Surgery Outcomes
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Pilonidal sinus disease is a chronic inflammatory condition of the skin and subcutaneous tissue that typically arises from hair follicles in the natal cleft of the sacrococcygeal region. The aetiology is debated but theorised to be a result of either the obstruction and subsequent inflammation of hair follicles, or acquired from hair penetrating through the skin into subcutaneous tissue.
It is a common problem affecting 26/100,000 of the general population, with an incidence of 1.1% in young adult males. It is a troublesome disease for patients, with negative impact on quality of life, mood, employment and self-image. It also results in a significant burden for the healthcare service, with high rates of recurrence and readmission following surgery. Definitive surgical management of Pilonidal sinus disease is challenging and remains a contentious issue. The aim of surgery is for the complete excision of affected tissue followed by prompt wound healing with a minimal recurrence rate. Numerous surgical procedures have been described for this purpose without a clear consensus on an optimal approach . Following excision, options for dealing with the resulting defect include healing by secondary intention, midline primary closure or lateral closure by a variety of flap techniques. The use of Platelet-rich plasma involves a complex network of molecular events which accelerate tissue regeneration due to its richness in growth factors plus a variety of biologic mediators. Platelet-rich plasma is an autologous product studied since the late 70s. It has been used in plastic and orthopedic surgery. It has a high concentration of platelets and growth factors (VEGF, PDGF, IGF-1, EGF). Platelets are activated and the suspension is applied to the desired location, stimulating vascular proliferation and promoting tissue healing. Platelet-rich plasma has more concentrated platelets than normal plasma (approximately 150-400×103 cell/dL). The presence of GFs in Platelet-rich plasma such as transforming growth factor-β, insulin-like growth factor1 co-stimulate the stem cells and fibroblasts secretions and promotes the fibrin matrix formation which effectively drive the healing process, induces regenerative response and lead to the damage structure repair in recovery of Pilonidal sinus disease disease. The aim of the present study is to find How Platelet-rich plasma treatment improves postoperative recovery in patients with pilonidal sinus disease.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Al Fayyum, Egypten
- Fayoum University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Patients with chronic pilonidal sinus .
- Patients with recurrent pilonidal sinus.
- Patients with large, painful pilonidal cyst.
- Patients with multiple sinus tracks.
Exclusion Criteria:
- High risk for general anesthesia.
- Patients with high fever (39 C ).(active infection)
- Patients with bleeding rash around the wound .(inflammatory skin conditions)
- Patients with infected pilonidal sinus.
- Patients with autoimmune skin diseases.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Group A( Platelet-rich plasma group)
Group A : patients who are undergoing excision of pilonidal sinus disease and followed by Platelet-rich plasma treatment.
|
patients who are undergoing excision of pilonidal sinus disease and followed by Platelet-rich plasma treatment
|
|
Placebo komparator: Group B (control group)
Group B: patients who are undergoing excision of pilonidal sinus disease and not followed by Platelet-rich plasma treatment.
|
Group B: patients who are undergoing excision of pilonidal sinus disease and not followed by Platelet-rich plasma treatment.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incidence of healing rate of the wound (dehiscence)
Tidsramme: One month postoperative
|
One month postoperative
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of complications : like drainage state , wound infection & bleeding
Tidsramme: one month postoperative
|
Complications : like drainage state , wound infection & bleeding
|
one month postoperative
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- SCCREIRB-MEDICINFAYOM-GU-001-0
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Behandling
-
University of OxfordMedical Research Council; P1vital Products LimitedAfsluttetEmotion | Bright Light Treatment | AnsigtsudtryksgenkendelseDet Forenede Kongerige
-
Soroka University Medical CenterAfsluttetOptimering af Second Line Treatment Protocol for H Pylori-udryddelseIsrael
-
Peking University Sixth HospitalIkke rekrutterer endnuKognitiv svækkelse | Major Depressive Disorder (MDD) | Neuroimaging | Bright Light TreatmentKina
-
New York State Psychiatric InstituteAfsluttetAfdækning af neurale og immune mekanismer for kroniske smerter i efterbehandling Lyme syndrom (PTLS)Kronisk smerte | Post Treatment Lyme Syndrome (PTLS)Forenede Stater
-
Tel Aviv UniversityAfsluttetAttention Bias Modification Treatment (ABMT)Israel
Kliniske forsøg med Group A :Platelet-rich plasma treatment
-
Antalya Training and Research HospitalThe Scientific and Technological Research Council of TurkeyUkendt