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

Fistula

Pathological Conditions, Anatomical

Anti-Infective Agents

Pharmaceutical Solutions

Dermatologic Agents

Phenol

Petrolatum

Curettage of the sacral cyst is performed using a disposable otorhinolaryngologists curette. The perimeter of the cyst is covered with petroleum jelly to protect the skin, and an Abbocath catheter 18 G is introduced into the cystic cavity. Undiluted 88% phenol is instilled into the cavity, ensuring that the cystic cavity is filled. It is maintained for 5 min until complete coagulation of the cyst is achieved.

entire exeresis is performed by means of an electric scalpel

In case of phenolization group, an Abbocath catheter 18 G is introduced into the cystic cavity. Undiluted 88% phenol is instilled into the cavity, ensuring that the cystic cavity is filled. It is maintained for 5 min until complete coagulation of the cyst is achieved.

phenolization

In case of conventional surgery, entire exeresis is performed by means of an electric scalpel

Conventional surgery

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

This is a single center randomized controlled clinical trial consisting in 2 treatment groups.

All patients admitted at University Hospital of Tarragona Joan XXIII with Sacrococcygeal pilonidal disease were likely to enter in the study. All patients with uncomplicated sacrococcygeal disease, localized in the midline and with only 1 fistulous orifice.

When the patients met the criteria and after consenting the admission in the study, they were included and were operated. The patients were randomly assigned to the phenolization group or conventional-surgery group. A unique anesthetic and surgical protocol were established for both groups.

Patients in the phenolization group underwent curettage with an otorhinolaryngology spatula and endocavitary phenol with an abocath needle until complete coagulation of the cyst. Patients in the conventional-surgery group were referred to conventional surgery consisting of complete excision of the cyst and closure by second intention. Both groups were managed without admission and discharged within a few hours if they met ALDRETE criteria. They were followed daily by the home hospitalization team

The main endpoint was short or medium-term recurrence of sacrococcygeal disease. The number of recurrences per group and the time from surgery to recurrence were assessed. Secondary endpoints included degree of satisfaction and sick leave

Clinical Trial to Test the Phenolization in Sacrococcygeal Pilonidal Disease

Randomized Clinical Trial to Test the Efficacy and Safety of Phenolization in Uncomplicated Sacrococcygeal Pilonidal Disease

Only anonymized data on anthropometric characteristics, surgery characteristics, and patient outcomes will be made available.

short or medium-term recurrence of sacrococcygeal disease. For this purpose, a clinical follow-up was performed in outpatient clinics where the patient was assessed and explored regularly for signs of recurrence. The number of recurrences per group and the time from surgery to recurrence were assessed

time from surgery to return to work. This will be counted in days.

HJ23

Principal investigator

Death

Seroma

Group 1 were treated with the new technique (Asymmetric Primary Closure and Additional Skin Excision).

In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume.

Group 2 were treated with the standard Karydakis technique.

In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume.

Asymmetric Primary Closure and Additional Skin Excision Technique

In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method

Standard Karydakis technique.

The aim of this study was to reduce the residual dead-space volume with a modification following the standard Karydakis procedure.

All patients were operated in the jack-knife position under spinal anesthesia (SA). The gluteal parts of the patients were stretched in both directions with bandage and intergluteal cleft was opened. Methylen blue was administered from the sinus openings in the gluteal region. Then, total sinus excision was performed, including the entire sinus tracts by passing the skin, subcutaneous tissues up to the presacral fascia.

In patients operated with standard Karydakis procedure, a flap (Karydakis flap) extending along the incision was prepared, with the medial side of the wound to be 1 cm deep and 2-3 cm inward. The prepared flap was shifted to medial and sutured to the presacral fascia with 2/0 vicryl.

In patients who were operated with the Asymmetric Primary Closure with Skin Excision Technique, after the Karydakis flap was formed, 5-10 mm skin was excised along the incision from the side of the flap to reduce the volume of the dead-space laterally.

In both groups, subcutaneous tissue was approximated with 2/0 vicryl. The skin was sutured with mattress technique using 2/0 Prolene. No drains were used in patients from either group.

Patients were followed up for wound leakage, seroma and hematoma formation, skin dehiscence and recurrence.

Asymmetric Primary Closure and Additional Skin Excision Technique.

A Novel Technique in the Treatment of Sacrococcygeal Pilonidal Sinus Disease: Effect of Reduction of Dead-space With Asymmetric Primary Closure and Additional Skin Excision Technique.

The study has been completed. The datas will be shared as an article

wound dehiscence, formation of seroma, hematoma, wound infection

Siverek Devlet Hastanesi

General surgeon

Infections

Abscess

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

Lidocaine

Anesthetics

Chlorhexidine

Chlorhexidine gluconate

Patients are placed in left-side position. After shaving, cleaning and scrubbing of the skin with alcoholic chlorhexidine, double strong tape is placed on the right buttock in order to increase exposure. Local anaesthesia is administered before incision with 20 ml xylocaine or lidocaine 1-2%. In principle, all sinusoidal pits are cut out with a margin of at least 1 mm with a biopsy core punch (4 mm, 6 mm or 8 mm depending on pit size) or an oval excision of the pits is performed. Hair and debris is removed from the sinus tracts with a small surgical spoon or mosquito clamp. Rigorous de-epithelialisation of the underlying sinus is performed with the spoon through every pit, whilst removing even more debris and hairs. At the end of the procedure a debris washout is performed with saline solution, the wounds are left open for secondary healing and sterile dressings are applied.

Pit-picking surgery

The pit picking procedure is described above. Subsequently, a radial diode laser probe at 1470 nm wavelength is used for delivering homogeneous (360 degrees) energy to the surrounding epithelium. The laser energy is 13 Joule, given continuously. First, a 'preparatory laser treatment' is performed to extract any missed hairs or debris, after which the sinus tracts are cleansed with a surgical spoon again. During the following definitive procedure, the probe is withdrawn at an approximate speed of 1 cm per three seconds, causing the small sinus tracts to shrink and close. Large sinus tracts remain open because very large sinus tracts or cavities cannot be closed with the 3mm laser fibre. The injury to the endothelium will cause granulation and create oedema for collapsing of the tract. The remaining open wounds are left open for secondary healing and sterile dressings are applied.

Pit-picking surgery with Sinus Laser assisted Closure

Justin Youp van Oostendorp, MD MSc

Robert Smeenk, MD PhD

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.

Multicentre, single-blinded, randomised, controlled, superiority trial. It

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

Success rate of treatment, defined as closure of all pits at 1 year follow-up. Closure of the pits will be assessed by the treating surgeon by means of an extensive physical examination.

Success rate of treatment at 3 and 5 years follow up

Pain scores in the period after surgery (VAS). VAS score scale: 0-10, higher score meaning a worse outcome.

PROMs, defined as persisting complaints: itching, wound fluid leakage, blood loss, pus, pain, social burden (shame/embarrassment). PROMs will be scored on a scale: 1-5, with a higher score meaning a worse outcome.

Time until return to daily activities; number of days

Recurrence rate at 1, 3 and 5 years of follow-up

Need for seondary or revision surgery for pilonidal disease

Patient satisfaction with treatment (scored on a likert scale 0-10, with a higher score meaning a better outcome)

Quality of life after treatment (Eq-5d-5l; will be converted to Quality adjusted life years (QALYs; range 0-1, with 1 the highest score and the better outcome)

Absence of symptoms at 1-yars follow-up: participants will be asked a dichotomous question during their 1-year follow-up appointment. At that moment, do they feel their symptoms from pilonidal sinus disease are: A) cured or improved when compared with before treatment? or B) unchanged or worse when compared with before treatment?

Flevoziekenhuis

Proctos Kliniek

Sint Jans Gasthuis Weert

UMC Utrecht

Ziekenhuis Amstelland

Treant ziekenhuis

Albert Schweitzer Hospital

dr. IJM Han-Geurts

Local investigator

50 Participants who underwent a total excision of the pilonidal sinus and the wound remained open for secondary healing.

50 Participants who underwent the same operation with secondary healing intention but on postoperative days 4 and 12 the platelet rich plasma was injected to the surgical wound.

Autologous PRP obtained via double centrifugation process of the participant's blood sample. PRP was prepared by the double Spain strategy.

Platelet Rich Plasma

The aim of the study is to assess the healing promotion effect of platelet rich plasma in patient being operated for sacrococcygeal pilonidal sinus disease by open excision

Sacrococcygeal Pilonidal disease is an infection of the skin and subcutaneous tissue at or near the upper part of the natal cleft of the buttocks. Pilonidal cavities are not true cysts and lack a fully epithelialized lining; however, the sinus tracts may be epithelialized.

Pilonidal sinus disease (PNS) has an incidence of approximately 26 per 100,000 population with a male predominance of 2:1 and the mean age of those affected is from 19 to 30 years of age. It occurs rarely after the age of 45 and children.

Pilonidal sinus disease is characterized by natal cleft suppuration due to hair follicle infection. The disease results from chronic infection of hair follicles and subsequent formation of a subcutaneous abscess because of persistent folliculitis. Hair then enters the abscess cavity and provokes a foreign body tissue reaction; chronic suppuration and discharge through a midline sinus follow.

Some individuals are asymptomatic with midline pits in the sacrococcygeal area, Symptomatic Pilonidal sinus results in chronic discharging wounds that cause pain and impact upon quality of life and social function. These sinuses may become infected and present as acute abscesses. Management of these abscesses is uncontroversial and revolves around incision and drainage, however, the mode of surgical management of the chronic discharging sinus is variable, contentious, and problematic.

The Principles of Surgical strategies require eradication of the sinus tract, complete healing of the overlying skin, and prevention of recurrence. Many methods are available for surgical management of PNS which is treated by wide excision. After excision, the wound may be left open to heal with granulation tissue, or may be immediate closed with a midline closure or by using a flap (Z-plasty, karydakis, Bascom or Rhomboid flaps). However, there is not yet a consensus on the optimal treatment.

Excision and healing by granulation is still preferred due to the low recurrence rate of (3.4%) compering with other methods (20.6%) for midline closure and (10.3%) for off-midline closure but the healing time is lengthy and requires a prolonged time of daily dressing with a risk of infection and delayed wound healing. Therefore, the search for a treatment with minimal pain, accelerated healing time and a short span of time for returning to the normal daily activities is vastly pursued.

A recent method to promote the wound-healing process is the local administration of an autologous platelet concentrate suspended in plasma named as platelet rich plasma (PRP) which contains growth factors. Concentrated growth factors have been reported to accelerate wound healing by 30-40% giving a satisfactory outcome in the treatment of chronic skin and soft tissue lesions, maxillofacial and plastic surgeries by presenting these high amounts of growth factors and chemokines.

When platelets become activated, Seven fundamental protein growth factors that are actively secreted by platelet initiate all wound healing process, including platelet derived growth factor (PDGF), epidermal growth factor (EGF), transforming growth factor (TGF), vascular endothelial growth factor (VEGF), Fibroblast growth factor (FGF), connective tissue growth factor (CTGF) \& insulin like growth factor (ILGF 1) all participate in the acceleration of wound-healing process.

Effect of Platelet Rich Plasma on Healing of Operated Pilonidal Sinus by Open Method

Assessment of the Effect of Platelet Rich Plasma on the Healing of Operated Sacrococcygeal Pilonidal Sinus by Open Method

Evaluation of Wound volume on postoperative days till complete healing of the wound in each group and compare rate of healing in both groups.

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
Clinical Trial to Test the Phenolization in Sacrococcygeal Pilonidal Disease	NCT05404243	Sacrococcygeal ... Pilonidal Sinus Pilonidal Disea... Pilonidal Disea...	phenolization Conventional su...	18 Years - 65 Years	HJ23
Asymmetric Primary Closure and Additional Skin Excision Technique.	NCT03424057	Pilonidal Sinus Pilonidal Disea... Surgical Techni...	Asymmetric Prim... Standard Karyda...	18 Years - 65 Years	Siverek Devlet Hastanesi
Asymmetric Primary Closure and Additional Skin Excision Technique.	NCT03424057	Pilonidal Sinus Pilonidal Disea... Surgical Techni...	Asymmetric Prim... Standard Karyda...	18 Years - 65 Years	Siverek Devlet Hastanesi
Clinical Trial to Test the Phenolization in Sacrococcygeal Pilonidal Disease	NCT05404243	Sacrococcygeal ... Pilonidal Sinus Pilonidal Disea... Pilonidal Disea...	phenolization Conventional su...	18 Years - 65 Years	HJ23
Comparing Minimally Invasive Treatments for Pilonidal Disease: LA POPA Trial (Laser And Pit-picking OR Pit-picking Alone)	NCT06140199	Pilonidal Sinus Pilonidal Disea... Pilonidal Sinus... Pilonidal Disea... Pilonidal Sinus...	Pit-picking sur... Pit-picking sur...	12 Years -	Proctos Kliniek
Effect of Platelet Rich Plasma on Healing of Operated Pilonidal Sinus by Open Method	NCT04430413	Pilonidal Disea...	Platelet Rich P...	18 Years - 45 Years	Kafrelsheikh University

Spots Global Cancer Trial Database for pilonidal disease of natal cleft