Randomised, double-blind, placebo-controlled study of the, efficacy and safety metronidazole ointment in facilitating resolution of non-healing pilonidal sinus
- Conditions
- Pilonidal diseaseChronic woundSkin - Other skin conditions
- Registration Number
- ACTRN12618002038279
- Lead Sponsor
- David Lubowski
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 90
1.Must give written informed consent.
2.Male or female aged greater than or equal to 16 years.
3.Previous surgery for pilonidal disease and failure of healing for more than 6 weeks post-surgical excision of the pilonidal cyst/sinus;
4.Willingness to stop all other concomitant topical preparations at the site of pilonidal disease.
1.Presence of non-drained abscess (abscess must have been drained more than 6 weeks prior to entry).
2.Patients who are due to undergo surgery related to pilonidal sinus.
3.Previous (in the last 2 weeks) or current treatment with any antibiotic based on medical history prior to screening.
4.Previous treatment with topical metronidazole for pilonidal sinus.
5.Known allergic reaction to metronidazole.
6.Known allergic reaction to excipients of IMP and placebo.
7.Subject is taking any prohibited medication (warfarin-type anticoagulants, fluorouracil, glucocorticoids, other topical preparations to the area of the wound, lithium, cyclosporin and disulfiram).
8.Experimental agents must have been discontinued at least 8 weeks prior to screening for a period equivalent to 5 half-lives of the agent (whichever is longer).
9.History of epilepsy or seizures.
10.Subject has hepatic insufficiency as defined by laboratory values outside the normal ranges.
11.Women who are pregnant or breastfeeding at baseline.
12.Subject with concurrent disease considered by the investigator to be clinically significant in the context of the study.
13.Patients who have clinically significant abnormalities on their screening blood tests. Clinically significant” will be determined by the surgeon at the study site.
14.Patients 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with healing at 6 weeks<br>Measured using PUSH score and defined by a PUSH score = 0 . [Assessed at 2,4 and the primary timepoint which is 6 weeks after commencement of intervention];Safety.<br>This will be assessed by the number and proportion of patients with treatment related AEs (as classified by the MeDRA) in all randomised patients receiving at least one dose.<br><br>[ 2, 4 and 6 weeks after commencement of treatment / placebo]
- Secondary Outcome Measures
Name Time Method The rate of wound healing in participants <br>Measured by using Puritan (TM) wound measuring probe ( wound length at 12 o'clock to 6 o'clock; max width and maximum depth) and calculated using = (baseline mm^3 - current mm^3 ) / baseline mm^3 x 100%<br><br>[2,4,&6 weeks after commencement of intervention];Patient’s global impression of improvement<br>Measured by Patient’s Global Impression of Improvement score (PGI-I) <br><br>[2,4,and 6 weeks after commencement of the intervention];The amount of metronidazole / placebo used.<br>Change in weight of tubes at baseline (measured in grams) by electronic scales and timepoints[2,4,and 6 weeks after commencement of the the intervention];Change in PUSH score <br>Measured by delta baseline PUSH and timepoints<br>[2,4 and 6 weeks after commencement of the the intervention ]