Cold Argon Plasma (CAP) Application in the Wound Treatment After Open Hemorrhoidectomy

Study Overview
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Brief Summary
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This is single-center, prospective, randomized study

Detailed Description
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This study will include patients with 3-4 stage hemorrhoids. They will undergo an operation of open hemorrhoidectomy. Patients will be divided into a study group and a control group. Study group patients during a post-operation period except a standard treatment (antiseptic solutions and antibacterial and wound healing ointments) of a post-operation wound will be treated with cold argon plasma. Control group patients will be treated with a standard treatment. Wound healing speed will be researched.

Official Title
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Cold Argon Plasma Application in the Wound Treatment After Open Hemorrhoidectomy

Conditions
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Cold Argon Plasma

Intervention / Treatment
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* Procedure: Wound healing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3-4 stage hemorrhoids 3 hemorrhoids Exclusion Criteria: patients underwent anal canals intervention acute hemorrhoids inflammatory bowel disease co-morbidity diseases of anal canal and perianal area concurrent conditions in the stage of decompensation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients after open hemorrhoidectomy (study group)<br>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. | Procedure: Wound healing<br>* 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.<br>|
| Active Comparator: Patients after open hemorrhoidectomy (control group)<br>Patients who during a post-operation period will be treated with a standard treatment.The usage of antibacterial and wound healing ointments daily. | Procedure: Wound healing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | Total wound healing will be assessed with the help of cytological and macroscopic methods.In the cytological method the presence of fibroblasts, mature epithelial cells, scar tissue formation and the absence of inflammation will be the criterion of wound healing, as well as the presence of macroscopic features of wound epithelialization. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity Measure | Visual analogue scale (0-10 points) | 2, 3, 4, 5, 6, 7, 8, 14, 21, 30 days | 
| Life quality | Short Form - 36 Health Status Survey | before operation, 8 days, 30 days | 
| Microbiological contamination of wound area | Microbiological contamination from the post operation wound area. The assessment of CAP effect on bacteria in planktonic and biofilm forms. 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). | 2, 8, 14, 21, 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cold argon plasma, hemorrhoidectomy, wound healing, hemorrhoids