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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 6 | Other Identifier | UW Madison | |
| A539790 | Other Identifier | UW Madison | |
| SMPH/SURGERY/PEDIATRIC SURGERY | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Syneron Candela | INDUSTRY |
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This project is a pilot study to determine if symptomatic pilonidal disease can be primarily managed with laser hair removal vs surgery.
This project will consist of surgical evaluation in pediatric surgery or colorectal surgery clinics, referral to dermatology clinic for informed consent, and if enrolled, participation in up to 8 laser hair removal sessions with regular follow-up for a period of 2 years after completion of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser hair removal treatment | Experimental | Patients who choose to enroll will plan to undergo a total of up to 8 laser hair removal sessions every 4-6 weeks. If patients develop abscess or infection during this time, they will undergo I&D and/or antibiotics, consistent with standard therapy for infection or abscess. If patients have 2 or more infections in 1 year, pain or drainage for more than 1 month, or miss more than 1 week of school or work due to ineffective treatment of pilonidal disease, these patients will undergo surgical excision and subsequent follow-up at surgeon's discretion. Patients will follow up at 2-4-week intervals for 3 months, then at 6, 9, and 18 months after conclusion of the laser therapy sessions. At all follow-up sessions, patients will be given the DQLI, CDQLI, and Promis 3A Pain survey. Unscheduled visits such as unplanned clinic visits, emergency department encounters, and hospitalizations, will be included in data collected for analysis of primary and secondary outcomes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser hair removal | Procedure | Those who consent to participate in the study will be treated with up to 8 sessions of laser hair removal utilizing a long-pulsed laser to the natal cleft at treatment intervals of 4-6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of disease-free remission | Disease free rate among those subjects who only required laser therapy. Disease-free remission will be assessed at 12 and 24 months. | up to 2 years |
| Disease recurrence rate among subjects who subsequently require surgical intervention. | Rate of recurrence of pilonidal disease among subjects who participated in the study but also required surgical intervention. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Characterization of the degree of intervention required to obtain positive results. | Incision and drainage vs. need for larger excision, requirement for oral antibiotics, and the number of emergency room visits, or hospital admissions related to pilonidal disease. | up to 2 years |
| Number of missed school or work days |
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Inclusion Criteria:
Patients with symptomatic pilonidal disease, who meet criteria for surgical intervention:
Exclusion Criteria:
Patients who have co-morbidities that prevent them from becoming a surgical candidate
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22269798 | Background | von Laffert M, Stadie V, Ulrich J, Marsch WC, Wohlrab J. Morphology of pilonidal sinus disease: some evidence of its being a unilocalized type of hidradenitis suppurativa. Dermatology. 2011;223(4):349-55. doi: 10.1159/000335373. Epub 2012 Jan 21. | |
| 7542011 | Background | Sondenaa K, Pollard ML. Histology of chronic pilonidal sinus. APMIS. 1995 Apr;103(4):267-72. doi: 10.1111/j.1699-0463.1995.tb01105.x. |
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|
This study will investigate qualitative outcomes including the number of missed school or work days at each follow up, 6, 9, and 18 months. |
| Up to 18 months |
| Assessment of Pain via Promis 3A Pain Short Form | This study will investigate qualitative outcomes including pain. Pain will be assessed via the Promis 3A Pain Short Form at 6, 9, and 18 months. This is a one question survey that has participants rate the intensity of their pain over the last 7 days, on average. The scale is from 0-10 where 0 is no pain and 10 is the worst pain imaginable. | up to 18 months |
| Number of Days Participants Experience Drainage | This study will investigate qualitative outcomes including assessment of drainage. This will be reported as the number of days participants experienced drainage since last follow up, assessed at 6, 9, and 18 month follow up. | up to 18 months |
| Cost-benefit analysis of laser hair-treated patients versus matched historical control. | Evaluate total cost to the health care system relative to period of disease-free remission. | up to 2 years |
| 7745322 | Background | Sondenaa K, Andersen E, Nesvik I, Soreide JA. Patient characteristics and symptoms in chronic pilonidal sinus disease. Int J Colorectal Dis. 1995;10(1):39-42. doi: 10.1007/BF00337585. |
| 20091589 | Background | Al-Khamis A, McCallum I, King PM, Bruce J. Healing by primary versus secondary intention after surgical treatment for pilonidal sinus. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD006213. doi: 10.1002/14651858.CD006213.pub3. |
| 23929010 | Background | Steele SR, Perry WB, Mills S, Buie WD; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the management of pilonidal disease. Dis Colon Rectum. 2013 Sep;56(9):1021-7. doi: 10.1097/DCR.0b013e31829d2616. No abstract available. |
| 29449548 | Background | Stauffer VK, Luedi MM, Kauf P, Schmid M, Diekmann M, Wieferich K, Schnuriger B, Doll D. Common surgical procedures in pilonidal sinus disease: A meta-analysis, merged data analysis, and comprehensive study on recurrence. Sci Rep. 2018 Feb 15;8(1):3058. doi: 10.1038/s41598-018-20143-4. |
| 17874268 | Background | Doll D, Krueger CM, Schrank S, Dettmann H, Petersen S, Duesel W. Timeline of recurrence after primary and secondary pilonidal sinus surgery. Dis Colon Rectum. 2007 Nov;50(11):1928-34. doi: 10.1007/s10350-007-9031-4. |
| 27003897 | Background | Khan MA, Javed AA, Govindan KS, Rafiq S, Thomas K, Baker L, Kenealy J. Control of hair growth using long-pulsed alexandrite laser is an efficient and cost effective therapy for patients suffering from recurrent pilonidal disease. Lasers Med Sci. 2016 Jul;31(5):857-62. doi: 10.1007/s10103-016-1920-0. Epub 2016 Mar 22. |
| 28521574 | Background | Dragoni F, Moretti S, Cannarozzo G, Campolmi P. Treatment of recurrent pilonidal cysts with nd-YAG laser: report of our experience. J Dermatolog Treat. 2018 Feb;29(1):65-67. doi: 10.1080/09546634.2017.1329513. Epub 2017 May 30. |
| 20002644 | Background | Oram Y, Kahraman F, Karincaoglu Y, Koyuncu E. Evaluation of 60 patients with pilonidal sinus treated with laser epilation after surgery. Dermatol Surg. 2010;36(1):88-91. doi: 10.1111/j.1524-4725.2009.01387.x. Epub 2009 Dec 4. |
| 29185064 | Background | Pronk AA, Eppink L, Smakman N, Furnee EJB. The effect of hair removal after surgery for sacrococcygeal pilonidal sinus disease: a systematic review of the literature. Tech Coloproctol. 2018 Jan;22(1):7-14. doi: 10.1007/s10151-017-1722-9. Epub 2017 Nov 28. |
| 16583183 | Background | Toosi P, Sadighha A, Sharifian A, Razavi GM. A comparison study of the efficacy and side effects of different light sources in hair removal. Lasers Med Sci. 2006 Apr;21(1):1-4. doi: 10.1007/s10103-006-0373-2. Epub 2006 Apr 1. |
| 10426883 | Background | Nanni CA, Alster TS. Laser-assisted hair removal: side effects of Q-switched Nd:YAG, long-pulsed ruby, and alexandrite lasers. J Am Acad Dermatol. 1999 Aug;41(2 Pt 1):165-71. doi: 10.1016/s0190-9622(99)70043-5. |
| 29217319 | Background | Mutus HM, Aksu B, Uzun E, Gulcin N, Gercel G, Ozatman E, Durakbasa CU, Okur H. Long-term analysis of surgical treatment outcomes in chronic pilonidal sinus disease. J Pediatr Surg. 2018 Feb;53(2):293-294. doi: 10.1016/j.jpedsurg.2017.11.031. Epub 2017 Nov 14. |
| 26282801 | Background | Pascoe VL, Kimball AB. Seasonal variation of acne and psoriasis: A 3-year study using the Physician Global Assessment severity scale. J Am Acad Dermatol. 2015 Sep;73(3):523-5. doi: 10.1016/j.jaad.2015.06.001. No abstract available. |
| 25040429 | Background | Kimball AB, Jemec GB, Yang M, Kageleiry A, Signorovitch JE, Okun MM, Gu Y, Wang K, Mulani P, Sundaram M. Assessing the validity, responsiveness and meaningfulness of the Hidradenitis Suppurativa Clinical Response (HiSCR) as the clinical endpoint for hidradenitis suppurativa treatment. Br J Dermatol. 2014 Dec;171(6):1434-42. doi: 10.1111/bjd.13270. Epub 2014 Nov 11. |