The aim of this clinical trial is to determine the effect of aloe vera gel on the healing of peristomal skin complications in patients with colostomy or ileostomy. The study population includes all patients with colostomy or ileostomy referred to colorectal clinics of Shiraz University of Medical Sciences and Milad Clinic. The study sample (60) will be selected by convenience sampling method and then will be divided into control and experimental groups by the random block method.
Inclusion criteria includes having colostomy or ileostomy and peristomal skin complications (getting 2-15 score based on DET score scale)and lasting at least 6 weeks from last radiotherapy and not having auto immune diseases or immunodeficiency. Exclusion criteria includes the use of another product on the peristomal skin or tumor relapse in the area or worsening the condition of peristomal skin during the intervention.
In the experimental group, the intervention includes using aloe vera gel on peristomal skin after each bag changing. In the control group, the intervention is the common methods using in each clinic.
The duration of intervention is six weeks and telephone follow up is done every 3 days. The data will be collected by DET score tools. The severity score of peristomal skin complications will be determined and recorded before intervention , and after 3 and 6 weeks of starting intervention .The expected impact is the decrease of DET score and healing peristomal skin complications after intervention .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061534556N1
Registration date:2017-06-27, 1396/04/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-27, 1396/04/06
Registrant information
Name
Negar Ejtemaei
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
stud2440060348@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shiraz University of Medical Sciences
Expected recruitment start date
2017-06-26, 1396/04/05
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aloe vera gel on the healing of peristomal skin complications in patients with colostomy or ileostomy
Public title
The effect of aloe vera gel on the treatment of peristomal skin complications
Purpose
Treatment
Inclusion/Exclusion criteria
having willingness to enter the study; having colostomy or ileostomy with peristomal skin complications (getting 2-15 score based on DET score scale); being at least 18 years old; not having auto immune diseases or immunodeficiency; lasting at least 6 weeks from last radiotherapy; not having sensitivity to aloe vera gel:Inclusion criteria.
not having willingness to enter the study; tumor relapse in the area; using another product on the peristomal skin; worsening the condition of peristomal skin during the intervention:Exclusion criteria.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central Building Shiraz University of Medical Sciences;Zand Ave ;Shiraz.
City
Shiraz
Postal code
Approval date
2017-02-18, 1395/11/30
Ethics committee reference number
IR.SUMS.REC.1395.195
Health conditions studied
1
Description of health condition studied
peristomal skin complications
ICD-10 code
k91.4
ICD-10 code description
colostomy and enterostomy malfunction
Primary outcomes
1
Description
peristomal skin complications
Timepoint
before intervention, 3 weeks after starting intervention, 6 weeks after starting intervention
Method of measurement
DET score tools
Secondary outcomes
empty
Intervention groups
1
Description
Intervention includes using aloe vera gel on peristamal skin after each bag changing.Purity percent of the gel is 99.9%. The gel should cover the skin surface with 1 mm thickness and use for 6 weeks:Intervention group
Category
Treatment - Drugs
2
Description
Intervention is the common methods using in each clinic:control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza clinic
Full name of responsible person
Negar Ejtemaei
Street address
Imam Reza clinic; Namazi Square; Shiraz; Iran
City
Shiraz
2
Recruitment center
Name of recruitment center
Milad clinic
Full name of responsible person
Negar Ejtemaei
Street address
Milad clinic; West Qodosi Street; Shiraz; Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Negar Ejtemaei
Street address
Shiraz University of Medical Sciences;Zand Ave;Shiraz;Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Negar Ejtemaei
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences;zand ave; Shiraz;Iran
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
negarejtemaei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahboube Magharei
Position
Graduate
Other areas of specialty/work
Street address
Department of Nursing, School of Nursing and Midwifery (R), Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
negarejtemaei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Negar Ejtemaei
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences;zand ave; Shiraz;Iran
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
negarejtemaei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)