Metronidazole Ointment in Non-healing Pilonidal Sinus Wounds

Summary

Title of Study: Randomised, double-blind, placebo-controlled trial evaluating the effects of metronidazole ointment in facilitating resolution on non-healing pilonidal sinus wounds Medical Condition Under Investigation Non-healing pilonidal sinus wounds Study centres: 2 Centres in Turkey Clinical Phase: Phase 2 Protocol Number: MET-PS-02 Study Design: Randomised, double-blind, placebo-controlled, parallel group study to determine the safety and efficacy of metronidazole ointment applied to the wound, following debridement in non-healing pilonidal sinus wounds. Planned Sample Size: 80 subjects

Timeline

Start

2021-10-01

Primary completion

2022-02-01

Completion

2022-05-01

Publications

• Background Akinci OF, Bozer M, Uzunkoy A, Duzgun SA, Coskun A. Incidence and aetiological factors in pilonidal sinus among Turkish soldiers. Eur J Surg. 1999 Apr;165(4):339-42. doi: 10.1080/110241599750006875.
• Background Ala S, Saeedi M, Eshghi F, Mirzabeygi P. Topical metronidazole can reduce pain after surgery and pain on defecation in postoperative hemorrhoidectomy. Dis Colon Rectum. 2008 Feb;51(2):235-8. doi: 10.1007/s10350-007-9174-3. Epub 2008 Jan 4.
• Background Maeda Y, Ng SC, Durdey P, Burt C, Torkington J, Rao PK, Mayberry J, Moshkovska T, Stone CD, Carapeti E, Vaizey CJ; Topical Metronidazole in Perianal Crohn's Study Group. Randomized clinical trial of metronidazole ointment versus placebo in perianal Crohn's disease. Br J Surg. 2010 Sep;97(9):1340-7. doi: 10.1002/bjs.7121.
• Background Saidy M, Ali A, Adewole A, Ambroze W, Schertzer M, King E, Armstrong D. (2016) Treatment of non-healing pilonidal disease using topical 10% metronidazole: a 10-year review. Annual scientific meeting American Society Colon and Rectal surgeon (ASCRS), April 30-May 4, Los Angeles, USA.
• 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.
• Background Ypsilantis E, Carapeti E, Chan S. The use of topical 10% metronidazole in the treatment of non-healing pilonidal sinus wounds after surgery. Int J Colorectal Dis. 2016 Mar;31(3):765-7. doi: 10.1007/s00384-015-2269-8. Epub 2015 May 24. No abstract available.

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Indications