- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Al Fayyum, Egitto
- Fayoum University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Group A( Platelet-rich plasma group)
Group A : patients who are undergoing excision of pilonidal sinus disease and followed by Platelet-rich plasma treatment.
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patients who are undergoing excision of pilonidal sinus disease and followed by Platelet-rich plasma treatment
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Comparatore placebo: Group B (control group)
Group B: patients who are undergoing excision of pilonidal sinus disease and not followed by Platelet-rich plasma treatment.
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Group B: patients who are undergoing excision of pilonidal sinus disease and not followed by Platelet-rich plasma treatment.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Incidence of healing rate of the wound (dehiscence)
Lasso di tempo: One month postoperative
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One month postoperative
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incidence of complications : like drainage state , wound infection & bleeding
Lasso di tempo: one month postoperative
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Complications : like drainage state , wound infection & bleeding
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one month postoperative
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- SCCREIRB-MEDICINFAYOM-GU-001-0
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Group A :Platelet-rich plasma treatment
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University of California, San DiegoReclutamentoArtrite al ginocchioStati Uniti