Protocol summary
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Study aim
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Determination of the effectiveness of ozone olive oil in wound healing in patients with pilonidal abscess treated with extensive tissue resection surgery
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Design
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A Two arm, triple blind, randomized controlled trial on 46 patients
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Settings and conduct
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The patients, the surgeon, the nurse who records the data and data analyser are blinded to the allocated groups
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Participants/Inclusion and exclusion criteria
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Age over 15 years and with the diagnosis of abscess and
Pilonidal sinus undergoing surgical treatment with extensive tissue resection
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Intervention groups
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In patients with operated pilonidal sinus abscess, conventional dressing and dressing with ozone olive oil are performed and the wound healing process is compared between the two groups
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Main outcome variables
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The severity of pain, infection, bleeding and wound healing
General information
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Reason for update
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The project manager's mistake in registering the sample size
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190423043356N3
Registration date:
2022-01-26, 1400/11/06
Registration timing:
prospective
Last update:
2023-12-25, 1402/10/04
Update count:
1
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Registration date
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2022-01-26, 1400/11/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-03-21, 1401/01/01
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Expected recruitment end date
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2023-03-21, 1402/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the effectiveness of ozone olive oil in wound healing of patients with pilonidal sinus treated with extensive tissue resection surgery
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Public title
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Evaluation of the effectiveness of ozone olive oil in wound healing of patients with pilonidal sinus treated with extensive tissue resection surgery
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Confirmation of the pilonidal sinus by the surgeon
Extensive removal of tissue
Age between 15-65
Exclusion criteria:
Age less than 15 years
Patient dissatisfaction
Past surgical history
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Age
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From 15 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
46
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be individually randomized using block randomization method in quadruple blocks by randomization.com website, Allocation concealment will be done using sealed, opaque, and sequentially numbered envelopes
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Researcher, Patients, The nurse who collects the data ,Data analyzer
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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It is a diagnostic and therapeutic method
Ethics committees
1
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Ethics committee
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Approval date
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2021-10-30, 1400/08/08
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1400.484
Health conditions studied
1
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Description of health condition studied
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Pilonidal sinus
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ICD-10 code
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K60
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ICD-10 code description
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Pilonidal sinus
Primary outcomes
1
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Description
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The severity of pain
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Timepoint
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Daily visits and then every other day up to 10 days and then weekly until the wound heals
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Method of measurement
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Physical examination by the surgeon and VAS score
2
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Description
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The severity of the bleeding
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Timepoint
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Daily visits and then every other day up to 10 days and then weekly until the wound heals
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Method of measurement
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Physical examination by the surgeon
3
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Description
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Infection
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Timepoint
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Daily visits and then every other day up to 10 days and then weekly until the wound heals
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Method of measurement
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Physical examination by the surgeon
4
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Description
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Wound healing
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Timepoint
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Daily visits and then every other day up to 10 days and then weekly until the wound heals
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Method of measurement
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Physical examination by the surgeon
Intervention groups
1
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Description
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Intervention group: standard treatment and ozone olive oil ointment
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Category
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Treatment - Drugs
2
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Description
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Control group: Standard treatment (daily irrigation with Normal Saline serum and dressing)
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available