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Evaluation of the effect of Teucrium Polium extract ointment in open wound healing of pilonidal sinus surgery

Protocol summary

Study aim
This study aimes to the determine effect of Teucrium Polium ointment on open wound healing of the Pilonidal sinus area.
Design
The study is a double blind, phase three, randomized study on 132 patients with intervention, control and placebo groups, in such a way that the cards containing letters A,B,C are thrown in a container; card A for the intervention group, card B for the control group and card C is for the placebo group.
Settings and conduct
The Study population are the patients referred to Shahid Beheshti Hospital in Yasouj who will undergo open pilonidal sinus surgery which is divided into three groups intervention (treatment with Teucrium Polium), control(treatment with normal saline), placebo(treatment with Osirin). The study is done double blind for the researcher and analyzer. After surgery, wounds of all three groups are washed with normal saline for up to a week, and then the considered dressing (Teucrium Polium, Osirine) is applied to the wound daily ,and all groups are observed and records the healing process of the wound weekly for up to two months with Seeing their doctor. The next visit and review in terms of recurrence will be three months later. Data analysis will be done using statistical tests.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 45 years, skin defect after open Pilonidal sinus surgery with size of 5-10cm, having a gluteal infection; exclusion criteria: Diabetes, cardiac and kidney diseases, immunodeficiency, history of chemotherapy, abnormal bleeding from the wound site, drug allergy.
Intervention groups
First intervenion group had Teucrium polium bandage, second group (control group) normal saline dressing, and the third group (placebo) had dressing with osirin.
Main outcome variables
Pilonidal sinus ulcer healing following open surgery; Pilonidal sinus ulcer Infection following open surgery; Recurrence of Pilonidal sinus.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200520047522N1
Registration date: 2021-09-20, 1400/06/29
Registration timing: retrospective

Last update: 2021-09-20, 1400/06/29
Update count: 0
Registration date
2021-09-20, 1400/06/29
Registrant information
Name
Seyed nooradin Hossini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 1813
Email address
nooradin.hosseini@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Teucrium Polium extract ointment in open wound healing of pilonidal sinus surgery
Public title
Evaluation of the effect of Teucrium Polium extract ointment in open wound healing of pilonidal sinus surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who underwent Pilonidal sinus surgery Disuse of drugs affecting wound healing Having a gluteal area infection
Exclusion criteria:
Chronic systemic disease (Kidney failure, Diabetes, Rheumatism, Immunodeficiency disease) Abnormal bleeding from the wound site Patients treated with Immunosuppressive drugs like Corticosteroids Drug allergy
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 132
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
All samples are given a card with the group code and the date of re-referral in order to remind the patient and the contact number of the registered researcher, neither the researcher nor the surgeon is aware of how the samples are in the three groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Shahid Beheshti Hospital, Shahid Montazari St., Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Approval date
2020-03-07, 1398/12/17
Ethics committee reference number
960581

Health conditions studied

1

Description of health condition studied
Pilonidal sinus
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Healing of a Pilonidal sinus ulcer following open surgery
Timepoint
Before the intervention and one, two, three, four, five, six, seven, eight weeks and 6 months after the starting consumption of Teucrium Polium ointment.
Method of measurement
Evaluation by the surgeon

Secondary outcomes

1

Description
Side effects (Allergy)
Timepoint
At all stages of project implementation
Method of measurement
As a regular visit and examination and recording the patient's complaints

Intervention groups

1

Description
The first intervention group: Dressing with Teucrium polium.To prepare the ointment, the plant is dried according to standards and extracted with 70% ethanol and then evaporates in a rotary apparatus at 40° C and incubated at 37°C to dry extract and the extract is dissolved in distilled water. And then prepared at the base of osirine 10%.For two months the ointment will be applied daily after washing the wound, and then every seven or eight week until six months,it is evaluated in person by a doctor.
Category
Treatment - Drugs

2

Description
Second Intervention group: dressing with Osirin, which is prepared in the form of Osirine 10% by a pharmacist and it will be applied to the wound daily For two months and then and every seven to eight week until six months ,it is evaluated in person by a doctor.
Category
Treatment - Drugs

3

Description
Control group:Normal siline lovage. The wound is washed daily with Normal saline solution for up to two months and evaluated in person by a doctor every seven to eight week until six month in person by a doctor.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Shahid Montazari St., Yasuj
Full name of responsible person
Seyed nooradin Hosseini
Street address
Yasuj, Beheshti Hospital of Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794867
Phone
+98 74 3322 1813
Email
nooradin.hoseini@yums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr.Hossein Mari Oryad
Street address
Yasuj University of Medical Sciences,Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7571875689
Phone
+98 74 3334 6078
Email
oryad.hossein@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed nooradin Hosseini
Position
Associate
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti Hospital, Shahid Montazari St., Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 2233 3181
Email
nooradin.hoseini@yums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed nooradin Hosseini
Position
Associate
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti Hospital, Shahid Montazari St., Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 1813
Email
nooradin.hosseini@yums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed nooradin Hosseini
Position
Associate
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti Hospital, Shahid Montazari St., Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 1813
Email
nooradin.hosseini@yums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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