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Pilonidal Disease clinical trials

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NCT ID: NCT05830734 Recruiting - Pilonidal Disease Clinical Trials

Injection of Freshly Collected Autologous Adipose Tissue Additional to Bascom's Cleft Lift Surgery

Start date: January 4, 2023
Phase: N/A
Study type: Interventional

In brief, the right management of complex or recurrent pilonidal disease (PD) is still controversial. In our institution we treat these conditions with Bascom's cleft lift surgery. Though this approach for most parts is beneficial, a large proportion of patients will suffer from prolonged post operative healing. We have published some positive results on treating non-healing postoperative wounds after cleft lift surgery with autologous fatty cell transplantation. The overall aim of the project is to investigate whether the addition of autologous fat cell transplantation in the surgical treatment of PD reduces the incidence of patients with prolonged postoperative healing. In a double-blinded randomized controlled clinical trial, we will investigate the effect of injections of freshly harvested autologous fatty cells in addition to Bascom's cleft lift operation versus Bascom's cleft lift operation alone.

NCT ID: NCT05439291 Recruiting - Pilonidal Disease Clinical Trials

Comparing Operative vs Non Operative Treatment for Pilonidal Disease

Start date: July 19, 2022
Phase: N/A
Study type: Interventional

The goal is to evaluate whether surgical excision of the pilonidal disease is needed after resolution of the initial symptoms when the patient follows regular hair removal regimen such as laser epilation.

NCT ID: NCT03483480 Recruiting - Pilonidal Sinus Clinical Trials

Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease

NPWTvsOT
Start date: May 21, 2018
Phase: N/A
Study type: Interventional

Pilonidal Disease is disease of young patients with significant morbidity and is difficult to treat. Currently multiple methods are practiced for the treatment of the disease, two of them are preferred over others and practice extensively. First one involves excision of pilonidal sinus and dressings while the second one is excision of the pilonidal sinus with application of negative pressure wound therapy. None of these approaches is considered superior to the other, as not enough comparison studies of the two procedures have been done. In order to clarify this and find the best option for our patients, investigators are taking opportunity to compare these two modalities. If participants choose to participate in this study they will be randomly selected to one of these groups and the progress of wound healing will be monitored after surgery with the measurement of wound weekly and photographs. Investigators are hoping to find out which procedure is superior. This will allow investigators to provide the best treatment option for their patients in future.

NCT ID: NCT02330159 Recruiting - Pilonidal Sinus Clinical Trials

Feasibility of a Novel Technique for Pilonidal Wound Healing

Start date: February 2015
Phase: N/A
Study type: Observational

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.

NCT ID: NCT01857128 Recruiting - Pilonidal Disease Clinical Trials

Pilonidal Disease Wound Healing Study

Start date: March 2013
Phase: Phase 4
Study type: Interventional

The purpose of the study is to learn about the best way to treat pilonidal cyst wounds and learn which type of bandage (or dressing) can help the wound heal faster after having surgery.

NCT ID: NCT01241136 Recruiting - Pilonidal Disease Clinical Trials

Open Wide Excision Versus Minimal Surgery for Pilonidal Disease

Start date: November 2010
Phase: N/A
Study type: Interventional

Pilonidal disease, a chronic infection involving the skin and subcutaneous tissues along the sacrococcygeal area (natal cleft) is a common disease affecting mostly young adult males who make up the majority of our military workforce. Surgical treatment options for pilonidal disease vary widely from the invasive (e.g. wide open excisions) to minimally invasive procedures (e.g. removal of lined sinus tracts using minimal excisions) as well as other popular treatments involving myocutaneous or skin flaps (Limberg flap and Z-plasty). All of these surgical procedures are associated with varying degrees of early and late recurrence rates; however, the current, more popular procedure for the treatment of pilonidal disease involves wide open excisions. A recent advancement in the minimally invasive surgical technique for pilonidal disease involves the use of Keyes trephines (a 2-to-9 mm diameter biopsy instrument) to excise the individual pits and to drain the cyst cavities. Although this procedure has been proven to be effective against pilonidal disease with an overall low early recurrence rate, no clinical trial has been performed to rate this procedure of minimal excisions against the current, more common procedure of wide open excisions. A recent report has suggested that the recurrence rate of pilonidal disease for minimal excisions may be comparable to that of wide excisions. Furthermore, reports have also suggested that this minimally invasive procedure can be performed with minimal (and possibly local) anesthesia, less post-operative pain medication, and may involve a shorter convalescence time for patients. In order to compare the early recurrence rates of pilonidal disease and overall patient satisfaction between procedures involving minimal and wide open excisions, we propose to perform a prospective, randomized clinical trial comparing these two surgical procedures. Randomly assigned patients will undergo either 1) wide excisions of all pilonidal-diseased tissue (e.g. pits, cavity, sinus tracts), including a surrounding rim of normal tissue and left open to heal, or 2) minimal excisions of lined sinus tracts using varying sized trephines. Overall patient satisfaction will be evaluated by the amount of analgesic used for the procedure, the number of dressing changes, the length of convalescence, and overall patient tolerance of the procedures, both intra- and post-operatively. In addition, varying data points will be collected with the use of a quality of life survey and visual analog pain scale to analyze overall patient satisfaction. Patients will be followed for a period of two years following surgery to evaluate for early recurrence of their pilonidal disease.