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

Not Applicable

• Conditions: Cold Argon Plasma
• Interventions: Procedure: Wound healing

• Registration Number: NCT03907306
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

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.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2019-03-22
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-04
• Last Update Submitted: 2019-04-04
• Study First Posted: 2019-04-08
• Last Update Posted: 2019-04-08
• Primary Completion: 2019-12-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients after open hemorrhoidectomy (study group)	Wound healing	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.
Patients after open hemorrhoidectomy (control group)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Life quality	before operation, 8 days, 30 days	Short Form - 36 Health Status Survey
Pain Intensity Measure	2, 3, 4, 5, 6, 7, 8, 14, 21, 30 days	Visual analogue scale (0-10 points)
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).

Trial Locations

Locations (1)

State Scientific Centre of Coloproctology; 🇷🇺 Moscow, Russian Federation