Clinical Research Directory

Prospective Study in Laser Treatment of Pilonidal Cysts

The goal of this observational study is to evaluate the recurrence rate after laser treatment of pilonidal sinus within two years of the procedure in adult patients who require this procedure to treat their pilonidal sinus. The main question it aims to answer is: • Is there a clinical recurrence (presence of a fistula in the intergluteal cleft) 2 years after laser treatment of pilonidal sinus? Participants who undergo surgery as part of their regular medical care will answer survey questions about recurrence at 1 and 2 years.

Topical Anti-Androgens in Pilonidal Sinus Disease

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.

Myriad™ Augmented Soft Tissue Reconstruction Registry

This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriad™ as part of the surgical intervention.

Pediatric Pilonidal Sinus Surgical Treatment

The aim of study to evaluate four different treatment options for pilonidal sinus disease in a randomized controlled trial to find the most suitable treatment option.

SiLaC Laser Technique for Pilonidal Sinus - La Paz Cohort Study.

Pilonidal sinus disease (PSD) is a chronic inflammatory condition of the sacrococcygeal region that frequently affects young adults, often causing pain, drainage, and recurrent infection. Traditional surgical approaches such as wide excision or flap techniques may result in prolonged healing times, relevant postoperative pain, and recurrence rates up to 20-30%. The SiLaC (Sinus Laser-Assisted Closure) technique is a minimally invasive procedure that uses a 1470-nm diode laser fiber to ablate the sinus epithelium and induce concentric contraction of the tract. International studies have reported promising results with faster recovery, minimal wound care, and low morbidity. This prospective single-center cohort study aims to evaluate the clinical outcomes and perceived recovery time of adult patients treated with the SiLaC® technique at Hospital Universitario La Paz (Madrid, Spain). The main outcome is the total recovery time perceived by patients after surgery. Secondary outcomes include postoperative complications, recurrence rate, pain intensity, need for wound care, and patient satisfaction. Data will be collected from medical records and structured follow-up interviews.

Bascom Cleft Lift for Primary Wound Healing in Complex and Recurrent Sacrococcygeal Pilonidal Sinus Disease

The goal of this observational study is to improve care for patients with complex or recurrent pilonidal sinus disease by developing and implementing a best practice care pathway, including a standardized cleft lift operation. The main question it aims to answer is: Does a best practice care pathway with standardized cleft lift operation lead to shorter wound healing time and time to return to normal activities, compared to current standard care, with traditional excision techniques.

ENVELOP: Wound Care Following Pilonidal Sinus Surgery

This is a single-blinded, multicentre, prospective randomised controlled trial (RCT) comparing post-operative and patient-reported outcomes for patients undergoing application of negative-pressure wound therapy (NPWT) after sinus tract excision as compared to excision and standard open wound care in chronic pilonidal sinus disease (PSD).

Comparison of Pit Picking, Phenol and Combined Pit Picking and Phenol Applications in Pilonidal Sinus Treatment

Pilonidal sinus disease is a common condition, and treatment options and outcomes vary greatly. Chronic symptomatic pilonidal sinus disease (PSD) primarily affects young adults and causes work loss. In this study, three treatment methods will be performed: the minimally invasive pit-picking procedure, crystallized phenol application (CPT), and a combined method (minimally invasive pit-picking procedure and CPT). The aim of this study is to compare the effectiveness of these three methods, evaluate short- and long-term results, and determine treatment success, the incidence of postoperative complications, chronic pain levels, recurrence rates, and patient satisfaction. Additionally, the effects of these methods on hospital stay, wound healing time, and workforce loss will also be examined.

Outcomes of Karydakis, Primary Closure, and Pit Picking Methods in the Treatment of Pilonidal Sinus: A Prospective Study in Women

Although there are many methods for the surgical treatment of pilonidal sinus disease, the number of studies specific to women is limited in the literature. In addition to post-treatment recurrence and complication rates in women, aesthetic results are also of great importance. This study will compare the Karydakis procedure, a flap method, and the Bascom's pit-pick procedure, a minimally invasive procedure, in terms of recurrence, complications and aesthetics, especially in female patients with three or fewer pits.

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

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.

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

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.

Pilonidal Sinus Disease

The aim of this study is to compare the outcomes of Karydakis technique versus sinus tract ablation procedure using 1470 nm Diode laser for the treatment of pilonidal sinus and provide evidence-based guidance to select the most appropriate operative procedure.

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

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).