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Pilonidal Disease clinical trials

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NCT ID: NCT06286397 Not yet recruiting - Pilonidal Sinus Clinical Trials

Topical Anti-Androgens in Pilonidal Sinus Disease

Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

The goal of this randomized clinical trial is to test the topical drug clascoterone in patients with pilonidal disease, which is a common, benign skin condition of the gluteal cleft. The main questions it aims to answer are: - Does clascoterone improve the severity of pilonidal disease as scored by a physician? - Does clascoterone improve patient symptoms due to pilonidal disease? - Does clascoterone improve the inflammation seen under the microscope in pilonidal disease removed at surgery Participants will apply clascoterone or a placebo cream to the diseased area for 3 months. They will be assessed every 4 weeks for disease severity assessed by a physician viewing patient photos and a symptom-based survey. Researchers will compare participants who received clascoterone treatment to those who received placebo.

NCT ID: NCT06206330 Completed - Pilonidal Sinus Clinical Trials

Effect of Platelet Rich Plasma (PRP) on Healing Time in Patients Following Pilonidal Sinus Surgery

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Our study was planned as a prospective controlled randomized study. The study was started after the ethics committee approval received from Dışkapı Yıldırım Beyazıt Training and Research Hospital. (23.08.2021 118/01). Two groups of patients were planned in parallel. In the treatment of pilonidal sinus disease, in patients operated on with the fistulotomy and curettage technique, one group was followed up with classical dressing, while the other group was followed up with PRP (platelet-rich-plasma) and classical dressing. Wound infection, hematoma, length of hospital stay, recurrence, pain in the first postoperative week, and time to complete epithelialization of the wound (in days) were evaluated between the two groups.

NCT ID: NCT06140199 Not yet recruiting - Pilonidal Sinus Clinical Trials

Comparing Minimally Invasive Treatments for Pilonidal Disease: LA POPA Trial (Laser And Pit-picking OR Pit-picking Alone)

LA POPA
Start date: January 2024
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to establish the efficacy of 'pit picking with laser therapy' versus 'pit picking alone' on both short and long-term outcomes in patients of 12 years and older with primary pilonidal sinus disease. The main questions it aims to answer are: - The overall success rate of treatment which is defined as: closure of all pits, and the absence of symptoms,persisting sinuses or recurrence of pilonidal disease within 12 months. - Secondary endpoints: wound closure time, patient experience, pain, complications, work rehabilitation, time to return to dailyactivities, quality of life, costs and the need for secondary or revision surgery. Participants will allocated to pit picking alone or combined with lasertherapy. The extra burden for participating patients is expected to be minimal to moderate. Patients will have two extra hospital visits in casethey are enrolled in our study: 6 and 12 months after enrolment. Postoperatively the normal scheme of follow up appointments wil be used: 2 and 6 weeks after treatment at the outpatient clinic of the treating surgeon. A telephone appointment with the researcher will be scheduled 4 weeks after treatment. Patients are asked to complete questionnaires at various time points, which will be sentto them by email and will take approximately 5-10 minutes each time. The content includes general and disease specific Quality of Life (QoL) questionnaires. We do not expect any extra adverse reactions or events in respect to participation in the study because both procedures are considered standard of care in the participating clinics. However, because both interventions are surgical procedures a small percentage of adverse events or postoperative complications can be expected.

NCT ID: NCT05830734 Recruiting - Pilonidal Disease Clinical Trials

Injection of Freshly Collected Autologous Adipose Tissue Additional to Bascom's Cleft Lift Surgery

Start date: January 4, 2023
Phase: N/A
Study type: Interventional

In brief, the right management of complex or recurrent pilonidal disease (PD) is still controversial. In our institution we treat these conditions with Bascom's cleft lift surgery. Though this approach for most parts is beneficial, a large proportion of patients will suffer from prolonged post operative healing. We have published some positive results on treating non-healing postoperative wounds after cleft lift surgery with autologous fatty cell transplantation. The overall aim of the project is to investigate whether the addition of autologous fat cell transplantation in the surgical treatment of PD reduces the incidence of patients with prolonged postoperative healing. In a double-blinded randomized controlled clinical trial, we will investigate the effect of injections of freshly harvested autologous fatty cells in addition to Bascom's cleft lift operation versus Bascom's cleft lift operation alone.

NCT ID: NCT05715983 Active, not recruiting - Pilonidal Disease Clinical Trials

Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom II Procedure.

SI-BAS
Start date: December 8, 2022
Phase: N/A
Study type: Interventional

Surgical treatment witn lateralization of intergluteal cleft is still gold standard for pilonidal sinus disaease. But nowadays minimally invasive treatment methods such as the use of a diode laser (SiLac, Sinus Laser Closure) to obliterate the coccygeal tract are used more often. The aim of the study is to compare a new minimal invasive method (laser treatment) with traditional method ( Bascom II) in terms of recurrence rate, complications and patients satisfaction with results.

NCT ID: NCT05569135 Completed - Pilonidal Disease Clinical Trials

Debridement and Laser Ablation Versus Debridement Alone in Pilonidal Disease

Start date: March 1, 2018
Phase:
Study type: Observational

This study aims to investigate the effect of laser ablation (LA) in minimally invasive management of pilonidal disease (PD). Data of the patients with PD who were eligible for simple debridement have been prospectively collected since March 2018, when laser ablation treatment came into use in our institution. Laser ablation treatment was offered to all eligible patients. All the patients underwent debridement (removal of hair and/or necrotic tissues through pits using a clamp/curette/brush) of PD; LA was added to the procedure in patients who were willing to have LA. The surgical outcome of two procedures was compared. The primary outcome measure was recurrence at 36 months.

NCT ID: NCT05439291 Recruiting - Pilonidal Disease Clinical Trials

Comparing Operative vs Non Operative Treatment for Pilonidal Disease

Start date: July 19, 2022
Phase: N/A
Study type: Interventional

The goal is to evaluate whether surgical excision of the pilonidal disease is needed after resolution of the initial symptoms when the patient follows regular hair removal regimen such as laser epilation.

NCT ID: NCT05404243 Completed - Pilonidal Sinus Clinical Trials

Clinical Trial to Test the Phenolization in Sacrococcygeal Pilonidal Disease

SPQF
Start date: January 1, 2021
Phase: Phase 4
Study type: Interventional

Randomized clinical trial to test the efficacy and safety of phenolization in uncomplicated Sacrococcygeal pilonidal disease

NCT ID: NCT05339828 Completed - Recurrence Clinical Trials

Unroofing Curettage for Pilonidal Disease

Start date: April 27, 2022
Phase:
Study type: Observational

This study aimed to investigate the outcomes of patients who underwent UC as the primary intervention for simple or complex SPD

NCT ID: NCT04697082 Completed - Pain Clinical Trials

Application of Platelet-rich Plasma in Pilonidal Sinus Disease

Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Pilonidal sinus disease is a common health-care problem, and surgical excision is the standard treatment modality. Controversy still exists regarding the best surgical technique for treating pilonidal disease in terms of minimizing disease recurrence and patient discomfort. In this study, the investigators compared the impact of autologous platelet-rich plasma (PRP) with that of minimally invasive techniques on pain reduction, return to daily activities, quality of life, and duration of wound healing after open excision and secondary closure.