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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03907306
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
State Scientific Centre of Coloproctology, Russian Federation

Brief Summary:
This is single-center, prospective, randomized study

Condition or disease Intervention/treatment Phase
Cold Argon Plasma Procedure: Wound healing Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cold Argon Plasma Application in the Wound Treatment After Open Hemorrhoidectomy
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Procedure: 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.

Active Comparator: 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.
Procedure: 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.




Primary Outcome Measures :
  1. Wound healing [ Time Frame: 30 days ]
    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.


Secondary Outcome Measures :
  1. Pain Intensity Measure [ Time Frame: 2, 3, 4, 5, 6, 7, 8, 14, 21, 30 days ]
    Visual analogue scale (0-10 points)

  2. Life quality [ Time Frame: before operation, 8 days, 30 days ]
    Short Form - 36 Health Status Survey

  3. Microbiological contamination of wound area [ Time Frame: 2, 8, 14, 21, 30 days ]
    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).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03907306


Contacts
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Contact: Nikita V. Tuktagulov +7 926 188 31 29 dr.tuktagulov@gmail.com

Locations
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Russian Federation
State Scientific Centre of Coloproctology Recruiting
Moscow, Russian Federation, 123423
Sponsors and Collaborators
State Scientific Centre of Coloproctology, Russian Federation

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Responsible Party: State Scientific Centre of Coloproctology, Russian Federation
ClinicalTrials.gov Identifier: NCT03907306    
Other Study ID Numbers: 120
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by State Scientific Centre of Coloproctology, Russian Federation:
Cold argon plasma
hemorrhoidectomy
wound healing
hemorrhoids