Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406621
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-05-06
Brief Title:
Pilot Trial Assessing the Effectiveness of Laser Hair Depilation on Pilonidal Disease Recurrence in Patients With Darker Skin Color
Sponsor:
Nemours Childrens Clinic
Organization:
Nemours Childrens Clinic
Study Overview
Official Title:
Pilot Trial Assessing the Effectiveness of Laser Hair Depilation on Pilonidal Disease Recurrence in Patients With Darker Skin Color
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pilot randomized trial assessing the effectiveness of laser hair depilation on pilonidal disease recurrence in patients with darker skin color
Detailed Description:
Focused study on laser hair depilation in patients with darker skin types is critical to promote equitable health care across all patients with pilonidal disease The investigators propose a pilot RCT of laser hair depilation to the gluteal cleft in darker skin adolescents and young adults with pilonidal disease to estimate the efficacy of laser hair depilation to decrease disease recurrence compared with standard of care This study will enroll patients with Fitzpatrick skin types IV-VI to be inclusive of both Hispanic and Non-Hispanic Black populations to allow us to investigate efficacy of this treatment across ethnic and racial groups and skin type
Specific Aim 1 To determine the efficacy of laser hair depilation to prevent recurrence of pilonidal disease at 1 year among patients with Fitzpatrick skin types of IV-VI The investigators hypothesize that laser hair depilation will lower disease recurrence at 1 year follow-up compared to mechanicaldepilation alone current standard of care
The investigators will perform an RCT comparing laser hair depilation with mechanicalchemical depilation intervention group to mechanicalchemical depilation alone control group
Primary outcome Disease recurrence at 1 year defined as development of an abscess folliculitis or draining sinus which requires treatment antibiotic therapy surgical incision and drainage or excision
Specific Aim 2 To investigate the efficacy of laser hair depilation to reduce pilonidal-related morbidity improve healthcare satisfaction and increase health-related quality of life HRQOL among patients with Fitzpatrick skin types IV-VI We hypothesize that laser hair depilation will reduce disability improve healthcare satisfaction increase HRQOL and lead to fewer procedures
Disability days defined as the number of reported days in which the patient was not able to participate in all activities or work will be calculated at 1 year and compared between the two groups
Patient satisfaction with care and HRQOL will be measured with validated PedsQLTM instruments
Procedures admissions emergency department visits and complications will be compared
This pilot study will generate the efficacy estimates needed to design a multicenter RCT to provide definitive evidence to support equitable inclusion of laser hair depilation as a treatment adjunct for pilonidal disease
Specific Aim 1 To determine the efficacy of laser hair depilation to prevent recurrence of pilonidal disease at 1 year among patients with Fitzpatrick skin types of IV-VI The investigators hypothesize that laser hair depilation will lower disease recurrence at 1 year follow-up compared to mechanicaldepilation alone current standard of care
The investigators will perform an RCT comparing laser hair depilation with mechanicalchemical depilation intervention group to mechanicalchemical depilation alone control group
Primary outcome Disease recurrence at 1 year defined as development of an abscess folliculitis or draining sinus which requires treatment antibiotic therapy surgical incision and drainage or excision
Specific Aim 2 To investigate the efficacy of laser hair depilation to reduce pilonidal-related morbidity improve healthcare satisfaction and increase health-related quality of life HRQOL among patients with Fitzpatrick skin types IV-VI We hypothesize that laser hair depilation will reduce disability improve healthcare satisfaction increase HRQOL and lead to fewer procedures
Disability days defined as the number of reported days in which the patient was not able to participate in all activities or work will be calculated at 1 year and compared between the two groups
Patient satisfaction with care and HRQOL will be measured with validated PedsQLTM instruments
Procedures admissions emergency department visits and complications will be compared
This pilot study will generate the efficacy estimates needed to design a multicenter RCT to provide definitive evidence to support equitable inclusion of laser hair depilation as a treatment adjunct for pilonidal disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None