Cold Argon Plasma (CAP) Application in the Wound Treatment After Open Hemorrhoidectomy
Cold Argon Plasma Application in the Wound Treatment After Open Hemorrhoidectomy
1 other identifier
interventional
100
1 country
1
Brief Summary
This is single-center, prospective, randomized study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 22, 2019
CompletedFirst Posted
Study publicly available on registry
April 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedApril 8, 2019
April 1, 2019
1.3 years
March 22, 2019
April 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30 days
Secondary Outcomes (3)
Pain Intensity Measure
2, 3, 4, 5, 6, 7, 8, 14, 21, 30 days
Life quality
before operation, 8 days, 30 days
Microbiological contamination of wound area
2, 8, 14, 21, 30 days
Study Arms (2)
Patients after open hemorrhoidectomy (study group)
EXPERIMENTALPatients 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)
ACTIVE COMPARATORPatients who during a post-operation period will be treated with a standard treatment.The usage of antibacterial and wound healing ointments daily.
Interventions
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.
Eligibility Criteria
You may qualify if:
- stage hemorrhoids
- hemorrhoids
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Scientific Centre of Coloproctology
Moscow, 123423, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2019
First Posted
April 8, 2019
Study Start
September 1, 2018
Primary Completion
December 31, 2019
Study Completion
March 31, 2021
Last Updated
April 8, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share