An interventional study of Wound healing in Cold Argon Plasma, sponsored by State Scientific Centre of Coloproctology, Russian Federation. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-08.
Sponsored by State Scientific Centre of Coloproctology, Russian Federation · Not applicable, Interventional, and Treatment
This is single-center, prospective, randomized study
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.
State Scientific Centre of Coloproctology, Russian Federation is the lead sponsor of 25 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
Time frame: 30 days
Pain Intensity Measure
Visual analogue scale (0-10 points)
Time frame: 2, 3, 4, 5, 6, 7, 8, 14, 21, 30 days
Life quality
Short Form - 36 Health Status Survey
Time frame: 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).
Time frame: 2, 8, 14, 21, 30 days
Plan to share: No
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This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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State Scientific Centre of Coloproctology, Russian Federation