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Pilonidal Sinus clinical trials

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NCT ID: NCT06391307 Recruiting - Pilonidal Sinus Clinical Trials

The Role of Mesenchymal Stem Cell and Exosome in Treating Pilonidal Sinus Disease in Children

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Chronic wounds that fail to heal over extended periods pose a significant financial burden on the healthcare system, underscoring the urgent need to enhance clinical treatments. Among the most promising approaches are stem cell-based therapies. Substantial evidence suggests that mesenchymal stem cells (MSCs) can facilitate the healing of chronic wounds in both animal models and preclinical studies, primarily through their paracrine actions. The bioactive factors and cytokines secreted by MSCs can be harvested in the form of conditioned medium. This medium has been processed into a lyophilized powder for clinical use. Patients with chronic wounds will recruited and divided into two groups: the control group will receive the commonly used fibroblast growth factor, while the experimental group was treated with the lyophilized powder. The study aims to assess the efficacy and safety of this Stem cell and exosome in treating chronic wounds (especially pilonidal sinus).

NCT ID: NCT06378918 Not yet recruiting - Pilonidal Cyst Clinical Trials

Comparison of the Effectiveness of the Simple Puncture Compared to the Incision of an Abscess on the piLOnidal Sinus

PILO
Start date: June 15, 2024
Phase: N/A
Study type: Interventional

Pilonidal disease is a common disease characterized by the presence of abscess in the intergluteal groove. During periods of abscess, current recommendations are to make a simple incision with daily wicking of the abscess. Direct excision at this time is not recommended because there is a risk of incomplete excision. The principle of directed healing after incision of the abscess results in an average dressing period of 21 days. A definitive resection is recommended after 4 to 6 weeks, when healing has been achieved, in order to limit the risk of infectious recurrence. An alternative has recently been proposed, consisting of a puncture of the abscess, aimed at emptying it under antibiotic coverage. The major advantage of this treatment is that patients no longer need general anesthesia to flatten the abscess. Although this technique is promising, it is currently not the subject of any published or ongoing randomized controlled study registered on Clinicaltrials.gov. The research hypothesis is that the two techniques have the same results in terms of recurrence before definitive surgical treatment but that drainage puncture would imply a faster healing time, a lower cost of treatment, a quality of superior support, reduced support time and reduced work stoppage.

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: May 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 at 12 months of follow-up. - Secondary endpoints: succes rat eof treatment during long-term follow-up, wound closure time, pain scores, complication rate, work rehabilitation, time to return to daily activities, quality of life, persisting complaints, patient satisfaction, 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. Participants 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. The investigators 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.