Cold Argon Plasma
Conditions
Keywords
Cold argon plasma, hemorrhoidectomy, wound healing, hemorrhoids
Brief summary
This is single-center, prospective, randomized study
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.
Interventions
PROCEDUREWound 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.
Sponsors
State Scientific Centre of Coloproctology, Russian Federation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Measure | 2, 3, 4, 5, 6, 7, 8, 14, 21, 30 days | Visual analogue scale (0-10 points) |
| Life quality | before operation, 8 days, 30 days | Short Form - 36 Health Status Survey |
| Microbiological contamination of wound area | 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). |
Countries
Russia
Contacts
Primary ContactNikita V. Tuktagulov
Outcome results
None listed