NCT03907306

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

Cold Argon Plasma Application in the Wound Treatment After Open Hemorrhoidectomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: State Scientific Centre of Coloproctology, Russian Federation · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cold Argon Plasma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-12-31
• Completion: 2021-03-31
• First posted: 2019-04-08
• Last updated: 2019-04-08

Locations

1 site across 1 country: Russia