Pilonidal SinusPhase 2NCT04273997
Metronidazole Ointment in Non-healing Pilonidal Sinus Wounds
A Phase 2 study testing Metronidazole 10% ointment in people with Pilonidal Sinus, run by S.L.A. Pharma AG at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pilonidal Sinus
- What is being tested?
- Metronidazole 10% ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 1 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must give written informed consent.
- Male or female aged ≥18 years.
- Previous surgery for pilonidal disease and failure of healing for ≥ 6 weeks post-surgical excision of the pilonidal cyst/sinus;
- Willingness to stop all other concomitant topical preparations at the site of pilonidal sinus wounds.
Who cannot join
- The subject will be excluded from the study if any of the following applies:
- Presence of non-drained abscess (abscess must have been drained ≥ 6 weeks prior to entry).
- Subjects who are due to undergo surgery related to pilonidal sinus.
- Previous use (in the last 2 weeks) or current treatment with any antibiotic. To be determined by medical history prior to screening.
- Previous treatment with topical metronidazole for pilonidal sinus.
- Known allergic reaction to metronidazole.
Show all 17Show fewer
- Known allergic reaction to excipients of IMP and placebo.
- Subject is taking any prohibited medication (warfarin-type anticoagulants, fluorouracil, glucocorticoids, other topical preparations to the area of the wound, lithium, cyclosporin and disulfiram).
- Experimental agents must have been discontinued at least 8 weeks prior to screening or for a period equivalent to 5 half-lives of the agent (whichever is longer).
- History of epilepsy or seizures.
- Subject has hepatic insufficiency as defined by laboratory values outside the normal ranges.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless surgically sterile must use effective contraception (either combined oestrogen and progestogen containing hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD], intrauterine hormone-releasing system [IUS], vasectomised partner, sexual abstinence (only considered an acceptable method of contraception when it is in line with the subjects' usual and preferred lifestyle), combination of male condom with either cap, diaphragm or sponge with spermicide [double barrier methods]), and willing and able to continue contraception for 1 month after the last administration of IMP. Women using oral contraception must have started using it at least 2 months prior to screening. Women are not considered to be of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels that have been confirmed to be in the "postmenopausal range". Or have had a surgical bilateral oophorectomy (with or without hysterectomy) or bilateral tubal ligation at least six weeks before the screening visit. In case of oophorectomy alone, the reproductive status of the woman should have been confirmed by follow up hormone level assessment.
- Women who are pregnant or breastfeeding at baseline.
- Subjects with concurrent disease considered by the Investigator to be clinically significant in the context of the study.
- Subjects who have clinically significant abnormalities on their screening blood tests. "Clinically significant" will be determined by the surgeon at the study site.
- Subjects who will be unavailable for the duration of the trial, deemed unable to comply with the requirements of the study protocol, likely to be noncompliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason.
- Subjects who show a 20% reduction in wound size between screening and baseline.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Erzincan Binali Yıldırım University General Surgery Clinic
Erzincan, 24100
Arda Isik, Prof., +90 533 0580707, ardaisik@erzincan.edu.tr
Arda Isik, Prof.
Samsun Training and Research Hospital General Surgery Clinic
Samsun, 55200
Ozan Kucuk, Assoc. Prof, +90 532 7626256, gultekinozan@hotmail.com
About this study
Official title: Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Metronidazole Ointment in Facilitating Resolution of Non-healing Pilonidal Sinus Wounds.
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
Read the detailed description
Route of Administration: Cutaneous
Investigational product and dosage:
Treatment Group A: Metronidazole 10% w/w ointment. A 2.5 cm strip of ointment (approximately 700 mg) will be administered topically to the wound together with suitable dressing, once daily.
One dose contains approximately 70 mg metronidazole in a formulation of white soft paraffin. The Investigator will demonstrate to the subject how to apply a 2.5 cm of IMP and dress the wound by applying the first dose and covering with a dry, gauze dressing which is to be retained with tape. Larger wounds may require additional amount of IMP to ensure sufficient cover of the wound.
Comparator and dosage:
Treatment Group B: Placebo ointment. A 2.5 cm strip of ointment (approximately 700 mg) will be administered topically to the wound together with suitable dressing, once daily.
One dose of placebo ointment contains titanium dioxide and white soft paraffin. The Investigator will demonstrate to the subject how to apply a 2.5 cm of IMP and dress the wound by applying the first dose and covering with a dry, gauze dressing which is to be retained with tape. Larger wounds may require additional amount of IMP to ensure sufficient cover of the wound.
Maximum Duration of Treatment:
The subject's participation in the study will last 10 weeks (including 2 week screening, 6 weeks clinical phase and 2 week follow-up phase).
Procedures:
Recruitment:
Subjects will be recruited through surgical out-patient clinics who will be contacted directly or through advertisements. Potential Subjects will have the opportunity to read or hear the study advertisement and contact the researcher through the contact details provided. Potential participants will have the opportunity to ask any questions to the researchers.
A member of the research team will then send a copy of the information sheet (either by email or post) or hand to the participant, who will have the opportunity to ask any questions to the researchers, either by email or phone.
Subjects expressing an interest in participating will be interviewed at their scheduled clinic appointment to explain the study in detail, and discuss the risks, benefits, goals and limitations of the study by the treating nurse.
Screening:
Potentially eligible Subjects will provide written informed consent prior to any study specific procedures being conducted.
Following the provision of written, informed consent, the Subject's demography, medical history, especially that relating to pilonidal sinus including details on surgical interventions, will be documented. Female Subjects of child-bearing potential will undergo a urine pregnancy test. Following a physical examination, height, weight and checks on vital signs, the Subjects will have blood samples drawn for routine haematology and biochemistry analyses. Subjects will be asked to provide details of any concomitant medications. The wound will be sized and graded using the Pressure Ulcer Scale for Healing (PUSH) tool 3.0. Subjects will have their wound assessed, then debrided and any surrounding hair removed by shaving, cleaned and dressed in accordance with normal management procedures.
Subjects with a confirmed diagnosis of non-healing pilonidal sinus wound, compliance with the inclusion and exclusion criteria and providing written informed consent will be registered on the electronic case report form (eCRF) to obtain a screening number.
The Investigator will demonstrate to the subject how to clean and dress the wound.
The subject will be educated on the use of the diary and asked to record at the end of each day the number of times they cleaned and dressed the wound and any changes in their condition or concomitant medication. Subjects will be asked to complete the diary over the subsequent 2 weeks.
Subjects not wishing to participate, or who are ineligible, will be followed up in accordance with the clinic's standard management procedures.
Baseline:
The subject will attend the clinic and the diary will be reviewed to ensure completion of the diary, the number of times the wound was cleaned and dressed, any changes in their condition or concomitant medications. Haematology and biochemistry test (from Screening) results will be confirmed as being acceptable.
Subjects will have the status of their pilonidal disease assessed and the wound will be sized and graded using the Pressure Ulcer Scale for Healing (PUSH) tool 3.0, to confirm that it remains unhealed with no improvement.
Subjects demonstrating improvement in the wound and healing in the screening period, will be followed up in accordance with the clinic's standard management procedures.
Female Subjects of child-bearing potential will undergo a pregnancy test. Subjects compliant with the inclusion and exclusion criteria will be randomised on a 1:1 basis to one of the two treatment groups: metronidazole 10%w/w ointment or matching placebo ointment. Randomisation will be stratified by wound size less than 3cm.
Following a physical examination, weight and checks on vital signs, blood samples will be drawn for routine haematology and biochemistry analyses. The wound will be swabbed for microbial analysis, then debrided and any surrounding hair removed by shaving.
The subject will be provided with two pre-weighed tubes of IMP together with a supply of sterile dressings. The Investigator will demonstrate to the subject how to apply 2.5 cm of IMP and dress the wound by applying the first dose and covering with a dry, gauze dressing which is to be retained with tape.
The subject will be retrained on completion of the diary and asked to record each day confirmation of wound cleansing, IMP dose application and wound dressing as well as any changes in their condition or concomitant medication.
Week 1:
One week after randomisation, the subject will be contacted by telephone to check on their progress, compliance with study medication, concomitant medications and the occurrence of any adverse events.
Weeks 2, 4 and 6 :
Two, four and six weeks after randomisation, the subject will attend the clinic for review of the healing status of their pilonidal disease including sizing of the wound and assignment of a PUSH score, together with checks on vital signs and a physical examination. In addition, the subject will complete the PGI I in relation to their pilonidal disease, relative to the baseline condition.
Haematology and biochemistry test (from Baseline) results will be confirmed as being acceptable (Week 2 Visit only).
At each visit the IMP tubes will be weighed to determine the amount used as a check on compliance with study treatment. The subject diary will be reviewed and any changes in symptoms and concomitant medications registered in the eCRF.
The Investigator will clean the wound and remove any surrounding hair by shaving. During each visit apply the dose of IMP and dress the wound for that day (Week 2 and Week 4 Visits only).
At the Week 6 visit, subjects will also provide blood samples for routine haematology and biochemistry analyses. Female subjects of child-bearing potential will undergo a pregnancy test. Subjects considered a clinical failure will have the pilonidal sinus wound swabbed for microbiological analysis.
In the event that the wound is judged to be completely healed at any visit, the subject will be instructed to stop applying the study medication. The Week 6 procedures will be performed and the subject will be asked to attend the clinic after a further 2 weeks, when the Week 8 procedures will be undertaken.
In the event that a subject wishes to withdraw prior to the end of the study, they will be asked to undertake the Week 6 procedures.
For subjects who have failed to heal, appropriate post-study treatment will be instituted.
Week 8 (follow-up):
Eight weeks after randomisation (or two weeks after a visit at which complete healing is confirmed), the subject will attend the clinic for review of the healing status of the pilonidal disease including wound size and PUSH score, together with checks on vital signs, changes in symptoms and concomitant medications. The subject will complete the PGI I in relation to their pilonidal disease, relative to the baseline condition. Haematology and biochemistry test (from Week 6 Visit) results will be confirmed as being acceptable.
Blood and urine sampling:
A blood sample will be drawn at the Screening, Baseline and Week 6 Visits for routine haematology and biochemistry tests.
Urine pregnancy tests will be conducted at Screening, Baseline and Week 6 Visits.
Safety Parameters:
Study subjects will be asked to record any changes in symptoms in the diary provided on a daily basis. This will be reviewed at each study visit and any adverse events will be documented in the eCRF. Changes in vital signs and outcome of routine blood analyses will be evaluated.
Adverse events (AEs) will be classified using a coding thesaurus (MedDRA).
Primary Endpoint:
Complete wound healing by Week 6.
Secondary Endpoints:
- Rate of wound healing [(baseline mm3 - Current mm3) / baseline mm3 x 100%
- Proportion of subjects with complete healing by Week 2 and 4
- Proportion of subjects with complete healing maintained over two consecutive visits
- Time to response, defined as complete healing
- Change from baseline in PUSH score at Weeks 2, 4 and 6
- Patient's Global Impression of Improvement (PGI-I) at Weeks 2, 4 and 6
Safety Endpoints:
The safety analysis will be conducted in all randomised subjects receiving at least one dose.
- Number and proportion of subjects with adverse events.
- Assessment of clinical laboratory parameters.
- Assessment of vital signs.
Statistical Analyses:
Proportion of subjects with complete healing and with partial healing will be presented using point estimates with 95% confidence intervals.
Differences in the rates of healing will be determined by difference in the mean. SE of the mean and 95% confidence interval will be reported.
Time to response will be presented in Kaplan-Meier curves. PUSH score will be presented by using point estimates with 95% confidence intervals. Comparisons between each treatment and placebo will be based on an Analysis of covariance (ANCOVA) model.
PGI-I will be presented by category using point estimates with 95% confidence intervals. Comparisons between each treatment and placebo will be based on a proportional odds model.
AEs will be classified into standard terminology using a coding thesaurus (MedDRA). Treatment-related AEs will be summarised separately from all AEs. In addition, the maximum intensity of AEs will be summarised. For AEs these will be summarized using descriptive statistics. Results of laboratory tests and measures of vital signs will be presented as summary statistics and as shift tables.
Missing data will be handled using a worst observation carried forward (WOCF) imputation. Sensitivity analyses will be included in the SAP.
- Conditions
- Pilonidal Sinus
- Being tested
- Metronidazole 10% ointment, Placebo ointment
- Medical subject headings
- Pilonidal Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole 10% ointmentDrug
Also called Ortem
Metronidazole 10% ointment
Placebo ointmentDrug
Placebo ointment
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole Ointment | Active comparator | Treatment Group A: Metronidazole 10% w/w ointment. A 2.5 cm strip of ointment (approximately 700 mg) will be administered topically to the wound together with suitable dressing, once daily.
One dose contains approximately 70 mg metronidazole in a formulation of white soft paraffin. The Investigator will demonstrate to the subject how to apply a 2.5 cm of IMP and dress the wound by applying the first dose and covering with a dry, gauze dressing which is to be retained with tape. Larger wounds may require additional amount of IMP to ensure sufficient cover of the wound Receives: Drug: Metronidazole 10% ointment |
| Placebo Ointment | Placebo comparator | Treatment Group B: Placebo ointment. A 2.5 cm strip of ointment (approximately 700 mg) will be administered topically to the wound together with suitable dressing, once daily.
One dose of placebo ointment contains titanium dioxide and white soft paraffin. The Investigator will demonstrate to the subject how to apply a 2.5 cm of IMP and dress the wound by applying the first dose and covering with a dry, gauze dressing which is to be retained with tape. Larger wounds may require additional amount of IMP to ensure sufficient cover of the wound. Receives: Drug: Placebo ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with complete healing by Week 6.
Proportion of subjects treated with Metronidazole ointment to placebo with complete healing by Week 6.
Measured: 6 weeks
Secondary outcomes (6)
Determine the effects of Metronidazole ointment on the time course of healing • Determine the effects of metronidazole in promoting partial healing
Rate of wound healing [(baseline mm3 - Current mm3) / baseline mm3 x 100%
Measured: 2-6 weeks
Subjects with complete healing by weeks 2 and 4
Proportion of subjects with complete healing by Week 2 and 4
Measured: 2-4 weeks
Maintaining of complete healing over consecutive visits
Proportion of subjects with complete healing maintained over two consecutive visits
Measured: 2-6 weeks
response time for complete healing
Time to response, defined as complete healing
Measured: 2-6 weeks
PUSH score change
Change from baseline in PUSH score at Weeks 2, 4 and 6
Measured: weeks 2, 4 and 6
Determine the effects of metronidazole on the patient's global impression of improvement
Patient's Global Impression of Improvement (PGI-I) at Weeks 2, 4 and 6
Measured: weeks 2, 4 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Oct 2021 (estimated)
- Primary completion1 Feb 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pilonidal SinusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, double-blind, placebo-controlled trial evaluating the effects of metronidazole ointment in facilitating resolution of non-healing pilonidal sinus wounds
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.L.A. Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arda Isik, Principal investigator, Study Principal InvestigatorOzan Kucuk, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273997
- Sponsor's protocol ID
- MET-PS-02
- Status last verified
- Sep 2021
- First submitted
- 15 Jan 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10365835Ala 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.
PubMed 18176825Maeda 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.
PubMed 20632322Saidy 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.
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.
PubMed 7745322Ypsilantis 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.
PubMed 26003119
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Metronidazole Ointment in Facilitating Resolution of Non-healing Pilonidal Sinus Wounds.
- ClinicalTrials.gov ID
- NCT04273997
- Acronym / sponsor ID
- MET-PS-02
- Conditions
- Pilonidal Sinus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- S.L.A. Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Route of Administration: Cutaneous
Investigational product and dosage:
Treatment Group A: Metronidazole 10% w/w ointment. A 2.5 cm strip of ointment (approximately 700 mg) will be administered topically to the wound together with suitable dressing, once daily.
One dose contains approximately 70 mg metronidazole in a formulation of white soft paraffin. The Investigator will demonstrate to the subject how to apply a 2.5 cm of IMP and dress the wound by applying the first dose and covering with a dry, gauze dressing which is to be retained with tape. Larger wounds may require additional amount of IMP to ensure sufficient cover of the wound.
Comparator and dosage:
Treatment Group B: Placebo ointment. A 2.5 cm strip of ointment (approximately 700 mg) will be administered topically to the wound together with suitable dressing, once daily.
One dose of placebo ointment contains titanium dioxide and white soft paraffin. The Investigator will demonstrate to the subject how to apply a 2.5 cm of IMP and dress the wound by applying the first dose and covering with a dry, gauze dressing which is to be retained with tape. Larger wounds may require additional amount of IMP to ensure sufficient cover of the wound.
Maximum Duration of Treatment:
The subject's participation in the study will last 10 weeks (including 2 week screening, 6 weeks clinical phase and 2 week follow-up phase).
Procedures:
Recruitment:
Subjects will be recruited through surgical out-patient clinics who will be contacted directly or through advertisements. Potential Subjects will have the opportunity to read or hear the study advertisement and contact the researcher through the contact details provided. Potential participants will have the opportunity to ask any questions to the researchers.
A member of the research team will then send a copy of the information sheet (either by email or post) or hand to the participant, who will have the opportunity to ask any questions to the researchers, either by email or phone.
Subjects expressing an interest in participating will be interviewed at their scheduled clinic appointment to explain the study in detail, and discuss the risks, benefits, goals and limitations of the study by the treating nurse.
Screening:
Potentially eligible Subjects will provide written informed consent prior to any study specific procedures being conducted.
Following the provision of written, informed consent, the Subject's demography, medical history, especially that relating to pilonidal sinus including details on surgical interventions, will be documented. Female Subjects of child-bearing potential will undergo a urine pregnancy test. Following a physical examination, height, weight and checks on vital signs, the Subjects will have blood samples drawn for routine haematology and biochemistry analyses. Subjects will be asked to provide details of any concomitant medications. The wound will be sized and graded using the Pressure Ulcer Scale for Healing (PUSH) tool 3.0. Subjects will have their wound assessed, then debrided and any surrounding hair removed by shaving, cleaned and dressed in accordance with normal management procedures.
Subjects with a confirmed diagnosis of non-healing pilonidal sinus wound, compliance with the inclusion and exclusion criteria and providing written informed consent will be registered on the electronic case report form (eCRF) to obtain a screening number.
The Investigator will demonstrate to the subject how to clean and dress the wound.
The subject will be educated on the use of the diary and asked to record at the end of each day the number of times they cleaned and dressed the wound and any changes in their condition or concomitant medication. Subjects will be asked to complete the diary over the subsequent 2 weeks.
Subjects not wishing to participate, or who are ineligible, will be followed up in accordance with the clinic's standard management procedures.
Baseline:
The subject will attend the clinic and the diary will be reviewed to ensure completion of the diary, the number of times the wound was cleaned and dressed, any changes in their condition or concomitant medications. Haematology and biochemistry test (from Screening) results will be confirmed as being acceptable.
Subjects will have the status of their pilonidal disease assessed and the wound will be sized and graded using the Pressure Ulcer Scale for Healing (PUSH) tool 3.0, to confirm that it remains unhealed with no improvement.
Subjects demonstrating improvement in the wound and healing in the screening period, will be followed up in accordance with the clinic's standard management procedures.
Female Subjects of child-bearing potential will undergo a pregnancy test. Subjects compliant with the inclusion and exclusion criteria will be randomised on a 1:1 basis to one of the two treatment groups: metronidazole 10%w/w ointment or matching placebo ointment. Randomisation will be stratified by wound size less than 3cm.
Following a physical examination, weight and checks on vital signs, blood samples will be drawn for routine haematology and biochemistry analyses. The wound will be swabbed for microbial analysis, then debrided and any surrounding hair removed by shaving.
The subject will be provided with two pre-weighed tubes of IMP together with a supply of sterile dressings. The Investigator will demonstrate to the subject how to apply 2.5 cm of IMP and dress the wound by applying the first dose and covering with a dry, gauze dressing which is to be retained with tape.
The subject will be retrained on completion of the diary and asked to record each day confirmation of wound cleansing, IMP dose application and wound dressing as well as any changes in their condition or concomitant medication.
Week 1:
One week after randomisation, the subject will be contacted by telephone to check on their progress, compliance with study medication, concomitant medications and the occurrence of any adverse events.
Weeks 2, 4 and 6 :
Two, four and six weeks after randomisation, the subject will attend the clinic for review of the healing status of their pilonidal disease including sizing of the wound and assignment of a PUSH score, together with checks on vital signs and a physical examination. In addition, the subject will complete the PGI I in relation to their pilonidal disease, relative to the baseline condition.
Haematology and biochemistry test (from Baseline) results will be confirmed as being acceptable (Week 2 Visit only).
At each visit the IMP tubes will be weighed to determine the amount used as a check on compliance with study treatment. The subject diary will be reviewed and any changes in symptoms and concomitant medications registered in the eCRF.
The Investigator will clean the wound and remove any surrounding hair by shaving. During each visit apply the dose of IMP and dress the wound for that day (Week 2 and Week 4 Visits only).
At the Week 6 visit, subjects will also provide blood samples for routine haematology and biochemistry analyses. Female subjects of child-bearing potential will undergo a pregnancy test. Subjects considered a clinical failure will have the pilonidal sinus wound swabbed for microbiological analysis.
In the event that the wound is judged to be completely healed at any visit, the subject will be instructed to stop applying the study medication. The Week 6 procedures will be performed and the subject will be asked to attend the clinic after a further 2 weeks, when the Week 8 procedures will be undertaken.
In the event that a subject wishes to withdraw prior to the end of the study, they will be asked to undertake the Week 6 procedures.
For subjects who have failed to heal, appropriate post-study treatment will be instituted.
Week 8 (follow-up):
Eight weeks after randomisation (or two weeks after a visit at which complete healing is confirmed), the subject will attend the clinic for review of the healing status of the pilonidal disease including wound size and PUSH score, together with checks on vital signs, changes in symptoms and concomitant medications. The subject will complete the PGI I in relation to their pilonidal disease, relative to the baseline condition. Haematology and biochemistry test (from Week 6 Visit) results will be confirmed as being acceptable.
Blood and urine sampling:
A blood sample will be drawn at the Screening, Baseline and Week 6 Visits for routine haematology and biochemistry tests.
Urine pregnancy tests will be conducted at Screening, Baseline and Week 6 Visits.
Safety Parameters:
Study subjects will be asked to record any changes in symptoms in the diary provided on a daily basis. This will be reviewed at each study visit and any adverse events will be documented in the eCRF. Changes in vital signs and outcome of routine blood analyses will be evaluated.
Adverse events (AEs) will be classified using a coding thesaurus (MedDRA).
Primary Endpoint:
Complete wound healing by Week 6.
Secondary Endpoints:
- Rate of wound healing [(baseline mm3 - Current mm3) / baseline mm3 x 100%
- Proportion of subjects with complete healing by Week 2 and 4
- Proportion of subjects with complete healing maintained over two consecutive visits
- Time to response, defined as complete healing
- Change from baseline in PUSH score at Weeks 2, 4 and 6
- Patient's Global Impression of Improvement (PGI-I) at Weeks 2, 4 and 6
Safety Endpoints:
The safety analysis will be conducted in all randomised subjects receiving at least one dose.
- Number and proportion of subjects with adverse events.
- Assessment of clinical laboratory parameters.
- Assessment of vital signs.
Statistical Analyses:
Proportion of subjects with complete healing and with partial healing will be presented using point estimates with 95% confidence intervals.
Differences in the rates of healing will be determined by difference in the mean. SE of the mean and 95% confidence interval will be reported.
Time to response will be presented in Kaplan-Meier curves. PUSH score will be presented by using point estimates with 95% confidence intervals. Comparisons between each treatment and placebo will be based on an Analysis of covariance (ANCOVA) model.
PGI-I will be presented by category using point estimates with 95% confidence intervals. Comparisons between each treatment and placebo will be based on a proportional odds model.
AEs will be classified into standard terminology using a coding thesaurus (MedDRA). Treatment-related AEs will be summarised separately from all AEs. In addition, the maximum intensity of AEs will be summarised. For AEs these will be summarized using descriptive statistics. Results of laboratory tests and measures of vital signs will be presented as summary statistics and as shift tables.
Missing data will be handled using a worst observation carried forward (WOCF) imputation. Sensitivity analyses will be included in the SAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomised, double-blind, placebo-controlled trial evaluating the effects of metronidazole ointment in facilitating resolution of non-healing pilonidal sinus wounds
| Arm | Type | Receives |
|---|---|---|
| Metronidazole Ointment | Active comparator | Drug: Metronidazole 10% ointmentTreatment Group A: Metronidazole 10% w/w ointment. A 2.5 cm strip of ointment (approximately 700 mg) will be administered topically to the wound together with suitable dressing, once daily. One dose contains approximately 70 mg metronidazole in a formulation of white soft paraffin. The Investigator will demonstrate to the subject how to apply a 2.5 cm of IMP and dress the wound by applying the first dose and covering with a dry, gauze dressing which is to be retained with tape. Larger wounds may require additional amount of IMP to ensure sufficient cover of the wound |
| Placebo Ointment | Placebo comparator | Drug: Placebo ointmentTreatment Group B: Placebo ointment. A 2.5 cm strip of ointment (approximately 700 mg) will be administered topically to the wound together with suitable dressing, once daily. One dose of placebo ointment contains titanium dioxide and white soft paraffin. The Investigator will demonstrate to the subject how to apply a 2.5 cm of IMP and dress the wound by applying the first dose and covering with a dry, gauze dressing which is to be retained with tape. Larger wounds may require additional amount of IMP to ensure sufficient cover of the wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must give written informed consent.
- Male or female aged ≥18 years.
- Previous surgery for pilonidal disease and failure of healing for ≥ 6 weeks post-surgical excision of the pilonidal cyst/sinus;
- Willingness to stop all other concomitant topical preparations at the site of pilonidal sinus wounds.
Key exclusion criteria (17 listed)
- Presence of non-drained abscess (abscess must have been drained ≥ 6 weeks prior to entry).
- Subjects who are due to undergo surgery related to pilonidal sinus.
- Previous use (in the last 2 weeks) or current treatment with any antibiotic. To be determined by medical history prior to screening.
- Previous treatment with topical metronidazole for pilonidal sinus.
- Known allergic reaction to metronidazole.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metronidazole 10% ointmentAlso: OrtemMetronidazole 10% ointment | Drug | Metronidazole Ointment |
| Placebo ointmentPlacebo ointment | Drug | Placebo Ointment |
Primary outcome
Proportion of subjects with complete healing by Week 6.
Time frame: 6 weeks
Proportion of subjects treated with Metronidazole ointment to placebo with complete healing by Week 6.
6 secondary outcomes
Determine the effects of Metronidazole ointment on the time course of healing • Determine the effects of metronidazole in promoting partial healing
Time frame: 2-6 weeks
Subjects with complete healing by weeks 2 and 4
Time frame: 2-4 weeks
Maintaining of complete healing over consecutive visits
Time frame: 2-6 weeks
response time for complete healing
Time frame: 2-6 weeks
PUSH score change
Time frame: weeks 2, 4 and 6
Determine the effects of metronidazole on the patient's global impression of improvement
Time frame: weeks 2, 4 and 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Background: PubMed 10365835Akinci 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: PubMed 18176825Ala 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: PubMed 20632322Maeda 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.
- BackgroundSaidy 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: PubMed 7745322Sondenaa 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: PubMed 26003119Ypsilantis 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.
- Individual participant dataSharing planned: No
Related trials for Pilonidal Sinus
Recruiting
VAAPS Combined With Loose Seton Drainage for Postoperative Self-Care: A Prospective Single-Arm Cohort Study
Pilonidal Sinus Disease
Not yet recruiting
Teach-Back Discharge Education After Pilonidal Sinus Surgery
Pilonidal Sinus Disease, Pilonidal Sinus Treatment
Recruiting
ENVELOP: Wound Care Following Pilonidal Sinus Surgery
Pilonidal Sinus, Wound Healing
Not yet recruiting
Laser Coagulation of Pilonidal Sinus With/Without Intraoperative Ultrasound Control
Pilonidal Cyst Without Abscess
Not yet recruitingObservational study
Urinary Bladder Matrix (UBM) Registry
Tissue Repair, Soft Tissue Reconstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arda Isik principal investigator
Study Principal Investigator
Ozan Kucuk principal investigator
Study Principal Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metronidazole 10% ointment in people with Pilonidal Sinus, run by S.L.A. Pharma AG at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin Slagel (+44 (0) 1923 681 001, jslagel@slapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with complete healing by Week 6. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04273997, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.