Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Symptoms and General Pathology

Pilonidal Sinus

Paranasal Sinus Diseases

Cysts

Nose Diseases

Respiratory Tract Diseases

Otorhinolaryngologic Diseases

Patients operated with the bilateral parallel elliptic flap technique.

Patients operated with the karydakis flap technique.

Advancement flap techniques in surgical treatment of pilonidal sinus disease.

Surgical treatment of pilonidal sinus disease

Sacrococcygeal pilonidal sinus disease (PSD) has been defined as a disease characterized by chronic inflammation and recurrent infections caused by the movement of hair toward the gluteal sulcus. This condition is especially seen in young men and negatively affects the quality of life of patients and prevents them from performing their work and school activities. The treatment options for PSD range from the use of antibiotics alone to reconstructed excision with tissue flaps. Although the optimal surgical treatment option remains controversial, expectations from the ideal surgical treatment include low recurrence and postoperative complication rates, early wound healing, short hospital stay, early return to work, and good cosmetic outcomes. The aim of this study was to compare the efficacy of the different flap techniques in the surgical treatment of PSD and evaluate the long-term outcomes of patients.

Comparison of Two Different Flap Methods in the Treatment of Pilonidal Sinus Disease

Bilaterally Parallel Elliptic Flap Versus Karydakis Flap in Pilonidal Sinus Disease: A Randomized Controlled Trial

All IPD that underlie results in a publication

Time to return to work in daily life after surgery

The pain scores of the patients were determined on the first postoperative day. The Visual Analog Scale (VAS), scored from 1 to 10, was administered to the patients to evaluate their postoperative pain levels.

Time to discharge from hospital after surgery

Atlas University

Asst. Prof.

Wounds and Injuries

Anti-Infective Agents

All Drugs and Chemicals

Hydrogen Peroxide

We considered 16 sinus excision by diathermy as a case group (named "Hot" group)

13 procedures performed by knife as control group (named "Cold" group).

In all interventions, the patients were placed in prone position on operating table with the gluteal line opened wide by adhesive patches; after skin disinfection, dimension and extension of cystic disease was studied by injection of hydrogen peroxide through superficial skin orifice. The same procedure was performed: an elliptical incision on midline around the sinus was made and the sinus was excided laterally and in depth on healthy tissue, down till the pre-sacral fascia: this common approach was made both using scalpel and electrosurgery in the two groups. During dissection and excision, in each group were measured and recorded the temperatures developing, both on the section surface using an infrared thermometer and thermal imaging camera, and deeper until 1 cm from the section frontline using a "immersion thermometer" sealed by a steri-drape to guarantee the sterility on surgical field. In this group excision was carried out with diatermocoagulation

In "hot" group 16 patients were treated by diathermy in "Cold"

the position and preparation of the patient on the operating table were the same as in the "hot" group, while the excision procedure performed with knife

in "Cold" group 13 patients were treated by scalpel.

Pilonidal disease is morbid condition of young productive population, that could impair quality of life with high cost for health care system. No consensus exists on optimal surgical treatment, even if several techniques have been proposed. In this preliminary experimental case-control study the investigators compared excision by knife and diathermy with the aim to investigate if wound dehiscence could be related to heat spreading during excision of the sinus.

Between January 2017 and February 2018, 29 patients underwent to sinus excision. The investigators considered 16 sinus excision performed by diathermy as a case group (named "Hot" group) and the last 13 procedures performed by knife as control group (named "Cold" group). Temperature data were recorded for both group. Follow-up was carried out until complete healing. Were considered primary and secondary outcomes.

Pilonidal Sinus Disease: Preliminare Study

Pilonidal Sinus Disease: Preliminary Case-control Study on Heat-related Wound Dehiscence

We established as primary outcomes, the number of wound completely healed after 8-12 days

the type of complication was divided into 2 types, Grade I and II

postoperative pain was recorded in the two groups using the analog pain scale (VAS, range 0-10, the lowest value indicates less pain and the highest value indicates)

the operative time for complete excision was compared into the two group

Ospedale di Cavalese

Central Nervous System Depressants

Pharmaceutical Solutions

Anesthetics

Phenol

Anti-Infective Agents, Local

Disinfectants

Sclerosing Solutions

In this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol into the wound.

In this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol + Exosome into the wound.

In this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol + Stem cell into the wound.

In this group, the classic non-operative technique is employed. The pilonidal sinus is debrided under local anesthesia, followed by the injection of crystallized phenol + Stem cell + Exosome into the wound.

Crystallized phenol + Exosome + Stem Cell

Crystallized phenol

Crystallized phenol + Exosome will be applied to wound area.

Crystallized phenol + Exosome

Crystallized phenol + Stem cell will be applied to wound area.

Crystallized phenol + Stem Cell

Crystallized phenol + Exosome + Stem Cell will be applied to wound area.

Mustafa Azizoğlu, MD, PhD

Mustafa Azizoğlu

Mustafa Azizoğlu, MD

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).

Pilonidal sinus disease (PSD) is an infectious or inflammatory condition beneath the skin at the peak of the gluteal cleft in the sacrococcygeal area. It is a chronic condition characterized by discharge, infection, and pain. Although it can occur during adolescence, it is most commonly seen in adult males, leading to a focus on adult treatments in research. Surgical treatment was first implemented by Anderson in 1847. Since then, various surgical and medical treatment options have been explored, yet there is no widely accepted standardized treatment. The ideal treatment should be simple, require a short hospital stay, have low recurrence rates, provide good cosmetic results, be cost-effective, cause minimal pain, and allow a quick return to social life, making the surgical approach contentious.

Maurice and Greenwood first reported the application of liquid phenol in 1964, initially under general anesthesia, later shifting to local anesthesia. Due to high recurrence rates with liquid phenol, Dogru and colleagues introduced the crystallized phenol (CP) procedure, a minimally invasive method now commonly used in adults.

Recent years have shown that stem cells and exosomes promote tissue healing and reduce inflammation. Known for their ability to differentiate into various cell types, stem cells, and exosomes play critical roles in intercellular communication, containing a variety of molecules. Their use in surgical fields has become popular as they speed up the post-operative healing process and reduce the risk of complications. Research in the literature supports that stem cells and exosomes accelerate wound healing (e.g., Nourian Dehkordi A, et al. 2019).

This study is based on two main premises: firstly, to identify the potential healing effects of stem cell and exosome applications in treating pilonidal sinus disease; and secondly, to comparatively assess the impact of these applications on surgical outcomes, specifically regarding surgery duration, complications, and the healing process. Comparing these two groups will help determine the value of stem cell and exosome applications in managing pilonidal sinus disease.

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

The Role of Mesenchymal Stem Cell and Exosome in Treating Pilonidal Sinus Disease in Children: A Prospective Randomized Controlled Trial

In the control group, the healing process generally takes about 2-3 weeks. In the experimental group, a shorter duration is expected. In this study, the wound healing times of both groups will be evaluated and compared.

In this study, the worst healing wounds will receive a score of 1, and the best-healed wounds, which are closest to normal skin, will receive a score of 10. In short, a low score indicates poor wound healing and poor cosmetic, while a high score indicates that the wound has achieved a good cosmetic appearance.

In patients treated with crystallized phenol, skin burns can occur during application. To prevent this, Furacin ointment is applied around the wound. However, we still encounter skin burns. In this study, it is expected that the experimental groups will have a lower burn rate compared to the control group. The burn rate will be evaluated in this study.

It refers to the time when patients return to their routine lives after the procedure.

Patient visual analog scale (VAS) scores will be assessed both prior to the procedure and again 10 days, 20 days following the procedure and after recovery.

The succes rate will be calculated after interventions

The recurrence rate will be calculated after interventions

Bleeding during interventions will be calculated

Infection will be defined during interventions and 10 days after intervention

Total complicaitons during interventions will be calculated

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Two Different Flap Methods in the Treatment of Pilonidal Sinus Disease	NCT05851690	Pilonidal Sinus	Surgical treatm...	-	Atlas University
Comparison of Two Different Flap Methods in the Treatment of Pilonidal Sinus Disease	NCT05851690	Pilonidal Sinus	Surgical treatm...	-	Atlas University
Pilonidal Sinus Disease: Preliminare Study	NCT03764657	Pilonidal Sinus	In "hot" group ... in "Cold" group...	14 Years - 52 Years	Ospedale di Cavalese
The Role of Mesenchymal Stem Cell and Exosome in Treating Pilonidal Sinus Disease in Children	NCT06391307	Pilonidal Sinus Pilonidal Disea...	Crystallized ph... Crystallized ph... Crystallized ph... Crystallized ph...	1 Day - 18 Years	Necmi Kadıoğlu Hospital

Spots Global Cancer Trial Database for pilonidal sinus disease