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

State Scientific Centre of Coloproctology, Russian Federation

Status: Unknown

Conditions: Cold Argon Plasma

Treatments: Procedure: Wound healing

Study type: Interventional

Funder types: Other

Identifiers

NCT03907306

120

Details and patient eligibility

About

This is single-center, prospective, randomized study

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Patients after open hemorrhoidectomy (study group)

Experimental group

Description:

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.

Treatment:

Procedure: Wound healing

Patients after open hemorrhoidectomy (control group)

Active Comparator group

Description:

Patients who during a post-operation period will be treated with a standard treatment.The usage of antibacterial and wound healing ointments daily.

Treatment:

Procedure: Wound healing