Cold Argon Plasma (CAP) Application in the Wound Treatment After Open Hemorrhoidectomy
NCT ID: NCT03907306
Last Updated: 2019-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-09-01
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients after open hemorrhoidectomy (study group)
Patients to whom during a post-operation period cold argon plasma and a standard treatment will be treated. Cold argon plasma will be applied during 4 minutes at one session on the 2nd, 3rd, 4th, 5th, 6th, 7th, 8th, 14th, 21nd, 30th day after operation. The usage of antibacterial and wound healing ointments daily.
Wound healing
The measurement of a wound area is committed on the 2nd, 8th, 14th, 21nd and 30th day after operation. By means of the mathematical formulas the wound healing speed will be defined. The wound process will be researched with the help of cytological method. The wound prints will be taken on the 2nd, 8th, 14th, 21nd and 30th day after operation. Microbiological research of a wound will be held on the 2nd, 8th, 14th, 21nd and 30th day after operation (in study groups before and after the usage of CAP, in control groups once). The pain assessment will be measured by a visual analogue scale on the 2nd, 3rd,4th, 5th, 6th, 7th, 8th, 14th, 21nd and 30th day after operation. The life quality will be researched by means of Health Status Survey on the 8th and 30th day before operation.
Patients after open hemorrhoidectomy (control group)
Patients who during a post-operation period will be treated with a standard treatment.The usage of antibacterial and wound healing ointments daily.
Wound healing
The measurement of a wound area is committed on the 2nd, 8th, 14th, 21nd and 30th day after operation. By means of the mathematical formulas the wound healing speed will be defined. The wound process will be researched with the help of cytological method. The wound prints will be taken on the 2nd, 8th, 14th, 21nd and 30th day after operation. Microbiological research of a wound will be held on the 2nd, 8th, 14th, 21nd and 30th day after operation (in study groups before and after the usage of CAP, in control groups once). The pain assessment will be measured by a visual analogue scale on the 2nd, 3rd,4th, 5th, 6th, 7th, 8th, 14th, 21nd and 30th day after operation. The life quality will be researched by means of Health Status Survey on the 8th and 30th day before operation.
Interventions
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Wound healing
The measurement of a wound area is committed on the 2nd, 8th, 14th, 21nd and 30th day after operation. By means of the mathematical formulas the wound healing speed will be defined. The wound process will be researched with the help of cytological method. The wound prints will be taken on the 2nd, 8th, 14th, 21nd and 30th day after operation. Microbiological research of a wound will be held on the 2nd, 8th, 14th, 21nd and 30th day after operation (in study groups before and after the usage of CAP, in control groups once). The pain assessment will be measured by a visual analogue scale on the 2nd, 3rd,4th, 5th, 6th, 7th, 8th, 14th, 21nd and 30th day after operation. The life quality will be researched by means of Health Status Survey on the 8th and 30th day before operation.
Eligibility Criteria
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Inclusion Criteria
* 3 hemorrhoids
Exclusion Criteria
* acute hemorrhoids
* inflammatory bowel disease
* co-morbidity diseases of anal canal and perianal area
* concurrent conditions in the stage of decompensation
18 Years
85 Years
ALL
Yes
Sponsors
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State Scientific Centre of Coloproctology, Russian Federation
OTHER_GOV
Responsible Party
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Locations
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State Scientific Centre of Coloproctology
Moscow, , Russia
Countries
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Central Contacts
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Other Identifiers
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120
Identifier Type: -
Identifier Source: org_study_id
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