Neoplasms

All Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Pilonidal Sinus

Cysts

Paranasal Sinus Diseases

Nose Diseases

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

All Drugs and Chemicals

Androgens

Androgen Antagonists

Participants will apply 1% clasocterone cream to the affected area twice daily got a total of 12 weeks with assessment visits at weeks 0, 4, 8, and 12. At assessment visits participants will have medical photography of the diseased area, be administered a dermatology-specific quality of life questionnaire, and be assessed for any side effects.

Participants will apply a vehicle cream matched in texture, appearance, and odor to clacoterone to the affected area twice daily got a total of 12 weeks with assessment visits at weeks 0, 4, 8, and 12. At assessment visits participants will have medical photography of the diseased area, be administered a dermatology-specific quality of life questionnaire, and be assessed for any side effects.

Application of 1% clascoterone cream twice daily to affected area for 12 weeks.

1% Clascoterone

Application of a vehicle cream to the natal cleft twice daily for 12 weeks

Vehicle Cream

Lillias Maguire, MD

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.

This is a randomized, double-blinded placebo-controlled trial. Recruitment The investigators will recruit patients from the University of Pennsylvania colorectal surgery clinics which consist of six high-volume surgeons and five advance practice providers across three hospitals serving a major metropolitan area. Patients considered for elective surgery will be recruited for the study and undergo a thorough informed consent process. Patients with asymptomatic disease and those with acute abscesses will be excluded as will patients who are pregnant or concurrently on a systemic anti-androgen (i.e. spironolactone). At the intake visit, patients will undergo a 1:1 randomization performed by the University of Pennsylvania's Investigational Drug Service (IDS). Recruited subjects will receive clascoterone or a vehicle cream matched for consistency, color, and container so that both subject and investigator are blinded to the assignment. At the intake visit, subjects will be advised to apply cream to cover the affected area twice daily for 12 weeks. At the intake visit, baseline disease assessment will be obtained including demographics, height and weight, medication usage, and personal history of PSD such as disease onset and prior procedures. Baseline disease measurements and medical photography will be obtained. Photographs will be taken with a dedicated camera, patients given a codified study ID, and data entered into a deidentified, HIPAA- compliant database.

I. Objective assessment of Disease Severity: Medical photography and analysis To objectively evaluate PSD, the investigators will obtain physical measurements of disease extent (left to right, cranial to caudal) and obtain disease photographs at baseline and weeks 4, 8, and 12. Photographs will be collected, deidentified, and provided to two colorectal surgeons for scoring. Surgeons will be asked to compare each timepoint to baseline and rate the PSD severity as significantly worsened, mildly worsened, unchanged, mildly improved, or significantly improved. Discrepant evaluations between surgeons will be referred to a third blinded surgeon.

II. Assessment of Dermatology Quality of Life Randomized subjects will be administered the Dermatology Life Quality Index (DLQI) at baseline and at 4, 8, and 12 weeks. The DLQI is a 10-question survey scored from 0-30 that has been applied widely across multiple dermatologic conditions and covers a range of potential quality of life impacts over a weekly basis. Specifically, the DLQI inquires about the impact of skin disease on symptoms ("Over the past week, how itchy, painful, or stinging has your skin been?"), daily activities, leisure, work and school, and personal relationships, as well as a question of impact of treatment ("Over the last week, how much of a problem has the treatment of your skin been?"). Subjects respond Very much, A lot, A little, or Not at all for descending scores of 3 to zero. A score at or above 10 is considered a significant impact on quality of life. Responses to the individual questions will be summed and responses compared between groups after unblinding at data analysis.

III. The investigators anticipate that a large portion of subjects in both groups will ultimately undergo surgery. Those that undergo surgery within 4 weeks will be selected for these analyses, on the hypothesis that the effect of clascoterone may subside at a longer interval. At surgery, blinded investigators will measure the left-right, cranial-caudal, and superficial-deep measurements of the excisional defect with a sterile ruler. The investigators will then follow patients with chart review in the electronic medical record for 8 weeks postoperatively to assess for immediate wound complications such as cellulitis, wound separation, abscess, and early recurrence.

III. Assessment of Cutaneous Inflammation A full thickness representative sample of the excised pilonidal cyst and adjacent normal tissue will be obtained at operation, fixed in formalin and delivered to the skin phenomics core of the University of Pennsylvania Skin Biology Disease Research Core (SBDRC). Following de-paraffination, rehydration, antigen retrieval, and blocking as necessary, SBDRC-validated antibodies will be applied to characterize the inflammatory infiltrate, specifically anti- CD3 (T- cells and Natural Killer Cells), anti-CD4 (helper T-cells), anti-CD8 (cytotoxic T-cells), anti-CD68 (macrophages), anti-CD79 (B cells). Investigators blinded to treatment groups will assess the specimens for epidermal, dermal, and subcuticular inflammatory infiltrates, hyperkeratosis, and follicular hyperplasia. Antibody-positive cells will be counted in six randomly selected fields under a light microscope at 400x magnification. Cell counts will be tallied and means and standard deviations compared between groups.

Randomized, Double-Blinded, Placebo-Controlled Trial

Topical Anti-Androgens in Pilonidal Sinus Disease

To objectively evaluate PSD, the investigators will obtain physical measurements of disease extent (left to right, cranial to caudal) and obtain disease photographs at baseline and weeks 4, 8, and 12. Photographs will be collected, deidentified, and provided to two colorectal surgeons for scoring. Surgeons will be asked to compare each timepoint to baseline and rate the PSD severity as significantly worsened, mildly worsened, unchanged, mildly improved, or significantly improved. Discrepant evaluations between surgeons will be referred to a third blinded surgeon. Data will be collated and analyzed in two fashions: as a 6-point ordinal outcome and collapsed into a dichotomous outcome with severely worsened to no change as a negative outcome and improvement as a positive outcome.

Randomized subjects will be administered the Dermatology Life Quality Index (DLQI) at baseline and at 4, 8, and 12 weeks. The DLQI is a 10-question survey scored from 0-30 that has been applied widely across multiple dermatologic conditions and covers a range of potential quality of life impacts over a weekly basis. Specifically, the DLQI inquires about the impact of skin disease on symptoms (Example: "Over the past week, how itchy, painful, or stinging has your skin been?"), daily activities, leisure, work and school, and personal relationships, as well as a question of impact of treatment ("Over the last week, how much of a problem has the treatment of your skin been?"). Subjects respond Very much, A lot, A little, or Not at all for descending scores of 3 to zero. A score at or above 10 is considered a significant impact on quality of life.

The investigators anticipate that a large portion of subjects will ultimately undergo surgery. Those that undergo surgery within 4 weeks will be selected. At surgery, blinded investigators will measure the excisional defect. The investigators will then follow patients with chart review in the electronic medical record for 8 weeks postoperatively to assess for immediate wound complications. A full thickness representative sample of the excised pilonidal cyst will analyzed including: antibodies against CD3, CD4, CD8, CD68, and D79. Investigators will assess the specimens for hyperkeratosis, and follicular hyperplasia.

University of Pennsylvania

Nervous System Diseases

Behaviors and Mental Disorders

Pain, Postoperative

Pain

Pathological Conditions, Anatomical

Postoperative Complications

Neurologic Manifestations

Quality of Life

Pharmaceutical Solutions

Anti-Infective Agents

Blood Substitutes

Coagulants

Micronutrients

Povidone-Iodine

Povidone

Hemostatics

Iodine

Cadexomer iodine

Minimally invasive pilonidal cyst surgery.

Radical surgical pilonidal cyst excision without suturing

Midline pits and secondary fistula openings were probed to determine the direction and length of any associated sinus tracts, followed by an excision with a 3 or 5 mm punch biopsy needle, depending on the size of the pit. A 2 cm lateral incision was made parallel to the pilonidal cyst. Hair and granulations within the sinus tracts were removed, and the cyst cavity was drained through the incision. Nonabsorbable monofilament sutures were used to close the excisional wounds of the pits and secondary fistula. Once haemostasis was achieved, the wound was covered with a sterile gauze with 10 % povidone-iodine solution.

Minimally invasive pit-picking surgery

Under the guidance of brilliant green, the cavity of the pilonidal cyst, along with the sinus tracts and fistulas, was marked. A symmetric elliptical incision was made to excise the pits and secondary fistula openings. The pilonidal cyst was removed from the healthy subcutaneous tissue and sacrococcygeal fascia using monopolar electrocautery. The wound was not sutured and was left open to heal by secondary intention. After haemostasis was achieved, the wound was covered with sterile gauze with 10 % povidone-iodine solution.

Radical surgical excision without suturing

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.

The first part includes the creation, adaptation, validity and suitability of the pilonidal cyst-specific quality of life questionnaire in assessing patients after pilonidal cyst operations, verification and evaluation of the quality of life and its dynamics after these operations. A survey of patients operated on for acute and chronic pilonidal cysts will be conducted. The main evaluation criteria of the first part will be the internal consistency of the questionnaire, the stability of the measurements, the construct validity and the frequency of patients with moderate and severe symptoms according to the specific quality of life questionnaire after pilonidal cyst surgery and the SF36v2 quality of life questionnaire.

The second part will compare two pilonidal cyst operations. A prospective, comparative, randomized clinical study will be conducted. This part of the study will study patients scheduled for surgery for chronic pilonidal cyst. Patients will be randomized into two groups, a group that will undergo radical excision of the pilonidal cyst without suturing the wound and a group that will undergo minimally invasive "pit picking" surgery. Patients will be interviewed before surgery, as well as on the first and second day after surgery. Discharged patients will complete quality-of-life questionnaires at 1, 2 weeks, and 2 months. Patients will be invited for a visit after 1 and 6 months, wound healing, disease recurrence and quality of life will be evaluated. The main evaluation criteria of the second part will be objective data - postoperative complications, wound healing time, duration of incapacity for work, frequency of disease recurrence and subjective data - changes in pain (VAS 10 cm scale) and quality of life total points according to SF36v2 and the specific life questionnaire created after radical pilonidal cyst excision and "pit picking" operations.

Patients' Quality of Life After Pilonidal Cyst Operations.

Evaluation of Patients' Quality of Life and Treatment Outcomes After Pilonidal Cyst Operations.

Patients fill out the the 36-Item Short Form Survey (SF-36). All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table. The scores from those questions that address each specific area of functional health status are then averaged together, for a final score within each of the 8 dimensions measured (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/ fatigue, emotional well being, social functioning, pain, general health). All 8 categories are scored in the same way.

Patients will note the duration of incapacity for work.

Patients will note the time when the wound healed.

Patients fill out a specific life questionnaire. This questionnaire consists of 20 questions, the value of each question is from 1 to 5 points. The minimum score value is 20, the maximum score value is 100. A lower score value indicates a better quality of life.

Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain at rest on a specified 100 mm scale at the specified time.

Disease recurrence will be assessed by clinical examination.

Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain

Lithuanian University of Health Sciences

Principal Investigator

Benjamin DARNIS, MD

Observational study on the treatment of pilonidal cyst with Holmium laser. Single-centre retrospective study of medical data from patients' medical records

From the medical records of a series of patients treated for pilonidal cysts with Holmium laser:

1. Primary objective: to assess the rate of healing at 1 month after Holmium laser treatment (healing being defined as no dressing)
2. Secondary objectives: to assess the following:

   * Healing rate at last follow-up (1 month after surgery)
   * Recurrence rate at last follow-up (1 month after surgery)
   * Consumption of \>1 level analgesics in the week and month following the procedure
   * Duration of nursing care

Treatment of Pilonidal Cyst With Holmium Laser

explanatory analysis of the healing rate at Month 1

GCS Ramsay Santé pour l'Enseignement et la Recherche

Vertical eccentric elliptical incision down to the post-sacral fascia, complete removal of unhealthy tissue, and normal tissue around the cyst and sinus tracts. Mobilization of the medial wound edge and advancement of the skin. Flap along the midline to the post-sacral fascia and suturing its margin to the lateral wound margin.

The flap is incised along the base of the wedge-shaped defect, and a small Burow's triangle is excised on the opposite side. The skin is mobilized and shifted in the direction of the arrow to close the defect. Excising the small Burow's triangle eliminates a dog ear at the base of the flap.

Pilonidal sinus surgery will be performed with the Karydakis Flap procedure.

Karydakis Flap Procedure

Pilonidal sinus surgery will be performed with the Burow's Triangle Advancement Flap procedure.

Burow's Triangle Advancement Flap Procedure

Muhammer Ergenç, MD

In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in terms of complications, time to return to normal activity, and recurrence.

Pilonidal sinus disease (PSD) is a chronic and inflammatory disease that is often generated in the sacrococcygeal region. It is commonly observed in puberty and young adult period and usually affects men. The incidence of pilonidal sinus disease is 26:100,000 and rising globally.

PSD risk factors contain young age, obesity, male gender, Mediterranean ethnicity, deep natal cleft, hairiness, and poor hygiene. It has been shown that PSD incidence increases in parallel with body weight. The precise etiology of pilonidal sinus disease is unclear. Many conservative and surgical methods have been described in treating pilonidal sinus disease. After the sinus area is excised, excision with laying open (secondary healing), excision with primary closure, marsupialization, and various flap techniques can be applied in surgical treatment. The primary principle in treatment is to ensure that the patient returns to normal life as soon as possible and eliminate recurrences. Although the best surgical technique in treating pilonidal sinus is controversial, the ideal operation should be cost-effective, simple to perform, short hospital stay, and have a low recurrence and complication rates. There is no definite consensus on an ideal technique yet.

In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in our clinic in terms of complications (wound dehiscence, seroma, hematoma, surgical site infection), time to return to normal activity, and recurrence.

Karydakis Flap Versus Burow's Triangle Advancement Flap in the Surgery of Sacrococcygeal Pilonidal Sinus Disease

Karydakis Flap Procedure Versus Burow's Triangle Advancement Flap Procedure in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus Disease

Postoperative pain after surgery ( measured by the visual analog score with 1 being minimum score and 10 being maximum score)

Number of weeks of complete duration epithelialization of the wound

Number of complications; related to the surgery, Type (wound dehiscence, seroma, hematoma, surgical site infection)

The number of weeks it passes the patient to return to normal activity.

Number of patients with recurrence pilonidal disease

Istanbul Sultanbeyli State Hospital

Wounds and Injuries

Subjects who have pilonidal disease that are being scheduled for surgical excision with our novel wound healing protocol. The disease can be actively infected or chronic.

All patients will undergo surgical excision of the pilonidal disease and application of the novel wound healing protocol. After excision, MatriStem MicroMatrix powder will be applied to the wound bed. A MatriStem Multilayer Wound Matrix sheet will then be placed over the MatriStem MicroMatrix, secured in place, then covered with surface dressings. The wound should be left undisturbed for 10-14 days (until the 1st follow-up visit). At the 1st postoperative visit, the wound will reassessed, and a second application of the MicroMatrix to the wound bed may be performed. At subsequent follow-up visits at 1, 3, and 6 months, the wound bed will be measured, photo documentation will be captured, and patients will complete a survey to assess quality of life.

Novel Wound Healing Protocol

Eric M Haas, MD

Deborah S Keller, MS MD

Pilonidal disease (PD) is a chronic disease with a major impact on patient quality of life and productivity. Thus, wound healing would have a significant effect on patient quality outcomes, patient quality of life, and healthcare utilization, as well as societal benefits from allowing this vital population to return to productivity. There is no consensus on postoperative wound care after surgery for PD. Negative pressure therapy is commonly used. However, this therapy is costly and cumbersome, and not evidence-based to optimize wound healing or postoperative patient or financial outcomes. The investigators goal is to investigate the impact of MatriStem® Wound Matrix and MicroMatrix® (ACell, Inc., Columbia, MD) on pilonidal wound healing. Secondary goals are to evaluate the impact of MatriStem Wound Matrix and MicroMatrix on postoperative outcomes, quality of life, and healthcare costs after surgical management of pilonidal disease.

The investigators study has 2 main goals:

Aim 1: To evaluate wound healing at 2 weeks, 1 month, 3 months, and 6 months postoperatively in a prospective MatriStem Wound Matrix and MicroMatrix cohort

Aim 2: To evaluate pilonidal recurrence, reoperation rates, healthcare utilization, and quality of life at 2 weeks, 1 month, 3 months, and 6 months postoperatively in a prospective MatriStem Wound Matrix and MicroMatrix cohort

The investigators main hypothesis is that using MatriStem Wound Matrix and MicroMatrix for postoperative wound care will significantly improve healing rates, healthcare utilization, and quality of life outcomes. The null hypothesis of the study is that there is no significant difference in healing rates, healthcare utilization, and quality of life outcomes between MatriStem Wound Matrix/ MicroMatrix and negative pressure dressing cohorts. The alternative hypothesis is that there are differences in healing rates, healthcare utilization, and quality of life outcomes between MatriStem Wound Matrix/ MicroMatrix and negative pressure dressing cohorts.

Twenty consecutive patients undergoing surgical excision for Pilonidal Disease will be recruited for treatment. All patients will undergo comparable surgical excision and application of the novel protocol. The wound will be left undisturbed for 10-14 days (until the 1st follow-up visit). At the 1st scheduled postoperative visit, the wound will reassessed in the operative suite, and a second application of the protocol may be performed at the surgeon's discretion. The next follow-up visits will be at 1 month, 3 months, and 6 months. At these visits, the wound bed will be measured, photo documentation will be captured, and patients will complete a survey to assess quality of life.

Study Endpoints are:

1. Wound healing at 6 months. Success is defined at a 60% healing rate of epithelialization and wound contracture by volume measurements in centimeters.
2. Observation of quality of life, total costs for treatment, recurrence and reoperation rates at 6 months

Feasibility of a Novel Technique for Pilonidal Wound Healing

A Feasibility Study of a Novel Technique for Pilonidal Wound Healing on Patient, Financial, and Quality of Life Outcomes

To evaluate healing at 2 weeks, 1 month, 3 months, and 6 months postoperatively in a prospective MatriStem Wound Matrix and MicroMatrix cohort

To evaluate quality of life at 2 weeks, 1 month, 3 months, and 6 months postoperatively in a prospective MatriStem Wound Matrix and MicroMatrix cohort

To evaluate recurrence and reoperation rates at 2 weeks, 1 month, 3 months, and 6 months postoperatively in a prospective MatriStem Wound Matrix and MicroMatrix cohort

Integra LifeSciences Corporation

Southeast Clinical Research Associates, Houston, Texas

Recurrence

Neoplasm Metastasis

Karydakis flap is a type of primary repair of the wound, after complete excision of sacral pilonidal cyst with 2 characteristics 1)lateralization of final scar 2)flattening of natal cleft

karydakis flap

laying open the site of excision of sinus or cyst without any flap

laying open

Amir Keshvari, Assoc. Prof.

Recurrence, Complications, Work-off date, Healing time and Patients Willingness in Karydakis Technique for Treatment of Sacrococcygeal Pilonidal Sinus versus Healing by Secondary Intention (EHSI) Technique in Imam Khomeini Hospital from 2008 to 2011

Karydakis Procedure Versus Excision With Healing by Secondary Intention (EHSI) in Sacrococcygeal Pilonidal Sinus

Recurrence, Complications, Work-off Date, Healing Time and Patients Willingness in Karydakis Technique for Treatment of Sacrococcygeal Pilonidal Sinus Versus Excision With Healing by Secondary Intention (EHSI)Technique

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Topical Anti-Androgens in Pilonidal Sinus Disease	NCT06286397	Pilonidal Disea... Pilonidal Disea... Pilonidal Sinus Pilonidal Cyst	1% Clascoterone Vehicle Cream	18 Years -	University of Pennsylvania
Patients' Quality of Life After Pilonidal Cyst Operations.	NCT05982028	Pilonidal Cyst Pain Postoperat... Quality of Life	Minimally invas... Radical surgica...	18 Years - 75 Years	Lithuanian University of Health Sciences
Treatment of Pilonidal Cyst With Holmium Laser	NCT05513898	Pilonidal Cyst		18 Years -	GCS Ramsay Santé pour l'Enseignement et la Recherche
Karydakis Flap Versus Burow's Triangle Advancement Flap in the Surgery of Sacrococcygeal Pilonidal Sinus Disease	NCT05289297	Pilonidal Sinus Sacrococcygeal ...	Karydakis Flap ... Burow's Triangl...	18 Years - 65 Years	Istanbul Sultanbeyli State Hospital
Feasibility of a Novel Technique for Pilonidal Wound Healing	NCT02330159	Pilonidal Disea... Pilonidal Cyst Pilonidal Sinus	Novel Wound Hea...	18 Years -	Southeast Clinical Research Associates, Houston, Texas
Karydakis Procedure Versus Excision With Healing by Secondary Intention (EHSI) in Sacrococcygeal Pilonidal Sinus	NCT00716937	Pilonidal Sinus Pilonidal Cyst	karydakis flap laying open	10 Years - 90 Years	Tehran University of Medical Sciences

Spots Global Cancer Trial Database for pilonidal cyst