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Pilonidal Sinus clinical trials

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NCT ID: NCT06324656 Recruiting - Pilonidal Sinus Clinical Trials

The Efficacy of Combining Platelet-rich Plasma With Crystallized Phenol in Pilonidal Sinus Disease

Start date: November 21, 2023
Phase: N/A
Study type: Interventional

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.

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: NCT06152952 Not yet recruiting - Clinical trials for Pilonidal Sinus Infected

Rhomboid Flap vs. Deep Suturing in Recurrent Pilonidal Sinus

Start date: December 2023
Phase:
Study type: Observational [Patient Registry]

This prospective clinical trial aims to compare the perioperative outcomes of rhomboid flap versus deep suturing in the management of recurrent sacrococcygeal pilonidal disease.

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: NCT06021392 Not yet recruiting - Pilonidal Sinus Clinical Trials

Comparative Study Between Wide Local Excision and Minimal Excision of Pilonidal Sinus

Start date: December 1, 2023
Phase:
Study type: Observational

Comparative study between wide local excision and minimal excision of pilonidal sinus

NCT ID: NCT05990569 Recruiting - Hemorrhoids Clinical Trials

Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia

Start date: August 12, 2023
Phase: N/A
Study type: Interventional

Study Description: The goal of this clinical trial is to compare the duration of postoperative pain relief achieved with two different approaches to pudendal nerve block in patients undergoing elective perianal surgery. The main question this study aims to answer is whether adding Methylene Blue to Bupivacaine pudendal nerve block can prolong postoperative analgesia compared to using Bupivacaine alone. Participants in this study will be individuals with ASA I and II physical status undergoing elective perianal surgery under spinal anesthesia. They will be randomly assigned to one of two groups: 1. Group A (Case Group): Participants will receive a pudendal nerve block with Bupivacaine combined with Methylene Blue. 2. Group B (Control Group): Participants will receive a pudendal nerve block with Bupivacaine alone. The pudendal nerve block will be performed using ultrasound guidance at the level of the ischial spine. The needle tip will be positioned between the Sacro tuberous and sacrospinous ligaments to inject the local anesthetic or the local anesthetic combined with Methylene Blue. Throughout the study, the researchers will monitor the time to the first rescue analgesic, assess pain levels using the Numeric Rating Scale at various time intervals (2, 6, 24, 48 hours, and 7 days), and observe for any side effects or complications related to the intervention. Participants will be closely observed after surgery to assess their pain levels and analgesic requirements. The researchers will also evaluate patient satisfaction using the Likert scale. By comparing the outcomes between the two groups, the study aims to determine if the addition of Methylene Blue to Bupivacaine pudendal nerve block provides superior postoperative analgesia in perianal surgery patients. This information will contribute to the understanding of effective pain management strategies for individuals undergoing perianal surgical procedures and potentially reduce the need for opioids and improve patient outcomes.

NCT ID: NCT05982028 Enrolling by invitation - Quality of Life Clinical Trials

Patients' Quality of Life After Pilonidal Cyst Operations.

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Biomedical research consists of two main parts. In the first part, the pilonidal cyst-specific quality of life questionnaire is compiled, adapted, validated, tested for suitability in assessing patients after pilonidal cyst operations. The second part will compare two pilonidal cyst operations. A prospective, comparative, randomized clinical study will be conducted.

NCT ID: NCT05900518 Completed - Clinical trials for Infected Pilonidal Sinus

A Promising Minimally Invasive Surgical Technique for the Treatment of Infected Pilonidal Sinus

LASER SILAT
Start date: June 27, 2018
Phase:
Study type: Observational

Infected pilonidal sinuses are a common pathology, affecting an estimated 0.7% of the population. In France, the most commun technique is extended exeresis with an open wound, followed by directed healing. This technique reduces the risk of recurrence, albeit at the cost of daily nursing care and a long healing period involving prolonged absence from work. Closure or plasty surgical techniques aimed at reducing the duration of nursing care are more restrictive, and seem to have higher recurrence rate. Minimally invasive treatment, such as phenolization and flattening with curettage of the sinus have existed for over 50 years, albeit with disappointing long-term results and morbidity that limits their application. Today, new minimally invasive treatments are being developed, aiming at a less constraining post-operative period. without compromising healing. These include glue, endoscopic treatment (EPSiT : Endoscopic Pilonidal Sinus Treatment or VAASP : Video-Assisted Ablation of Pilonidal Sinus) and laser treatment (SiLaT procedure : Sinus Laser Therapy or PiLaT : Pilonidal disease Laser Treatment). Laser treatment is used since 2014 in the treatment of anal fistulas and more recently in the treatment of infected pilonidal sinus. A laser fiber is introduced, under local or general anaesthesia, into the main cavity and secondary tracts after curettage and opening of the dimples. The energy delivered by the laser is transmitted in the form of heat, in order to seal the cavity during healing of thermal lesions. Initial results report success rates of around 90%, with a healing time of between 1 and 2 months. It also appears to be effective after failure of previous surgery. In cases of incomplete closure or recurrence, a second laser treatment can be performed with high healing rates. The investigators carried out an retrospective study including 29 patients treated with the SILAT technique. The healing rate, defined as the absence of symptoms and recurrence of suppuration, was around 70%. The procedure was painless and no serious complications were observed. The presence of one or more secondary orifices and overweight were associated with a higher risk of failure. In order to confirm these results, to better specify the factors predictive of success, and to evaluate the efficacy of SiLaT in the longer term, the investigators will carry out a single-center study including all adult patients treated with laser between June 2018 and December 2020.

NCT ID: NCT05892198 Completed - Pilonidal Sinus Clinical Trials

A Single Center Experience in the Management of Pilonidal Disease

Start date: January 1, 2015
Phase: N/A
Study type: Interventional

Sacrococcygeal pilonidal disease (PND) is a common entity affecting the skin and subcutaneous tissue of the upper portion of the natal cleft of the buttocks. It is characterized by the presence of sinus tracts with recurrent inflammation and infection. It poses a significant healthcare problem due to its related morbidity, impaired quality of life, and financial costs.