Evaluation of Acacia Senegal Gum Effect on Preventation And Treatment of Peristomal Skin Disorder in Children in alzahra hospital , Isfahan, IRAN 2010-2011
AIM: to evaluate the effect of acacia Senegal gum in treatment/management of the ostomy complications of the peristomal skin area defects, skin situation (chemical irritation and mechanical trauma).
METHODS: a ll children with stoma and peristomal skin disorder were eligible to participating in my research: 10 patients were observed for 8 months (5-under effect of acacia Senegal gum, 5- under effect of zinc oxide ointment.We used acacia Senegal gum to prevention and treatment of peristomal skin disorder in trial group and zinc oxide ointment as same in control group to comparison the wound skin healing in each group. We use the acacia Senegal gum and zinc oxide in order to understand the effectiveness of material within period of 8 days .The clinical observation methods with especial assessment tools DET and get
Photograph) were used. The peristomal complications were positively influenced by the use of the acacia Senegal gum .
The effect of acacia Senegal gum in compare to zinc oxide for treatment of peristomal skin disorders almost thesame
General information
Acronym
Peristomal Skin Complication
IRCT registration information
IRCT registration number:IRCT201112178431N1
Registration date:2013-11-13, 1392/08/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-13, 1392/08/22
Registrant information
Name
Afsaneh Pirnia Naeini
Name of organization / entity
Alzahra Hospital
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 5555
Email address
afsaneh@stu.kanazawa-u.ac.jp
Recruitment status
Recruitment complete
Funding source
National Research Council of Isfahan University Approved With Given Main Money
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Acacia Senegal Gum Effect on Preventation And Treatment of Peristomal Skin Disorder in Children in alzahra hospital , Isfahan, IRAN 2010-2011
Public title
Evaluation of Acacia Senegal Gum Effect on Preventation And Treatment of Peristomal Skin Disorder in Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : The children with ostomy who are hospitalized in pediatric ward of AL Zahra hospital Isfahan province in Iran and exclusion criteria was patient that refuse to be under of our study ; patient with congenital sensetive skin
Age
From 1 year old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences.Vice Chancellor for Research
Street address
Isfahan University of Medical Sciences.Hezar Jarib Street
City
Isfahan
Postal code
8174675731
Approval date
2008-05-11, 1387/02/22
Ethics committee reference number
287239
Health conditions studied
1
Description of health condition studied
Peristomal Skin Disorder
ICD-10 code
K91.4
ICD-10 code description
Colostomy and enterostomy malfunction
Primary outcomes
1
Description
Treatment of Peristomal Skin Disorder in Area and Severity
Timepoint
every 2 days follow up for 8 days
Method of measurement
Check List(DET Score),Photography Sizeing in AUTO CAD
2
Description
Measurement of wound skin healing
Timepoint
2 days
Method of measurement
Autokad Softwaer and Photography
Secondary outcomes
1
Description
Wound Healing
Timepoint
Days Zero.Two.Four.Six.Eight
Method of measurement
DET Scoring Check List and Take Photograph and AUTO CAD analysis
2
Description
Wound Healling
Timepoint
2 Days
Method of measurement
Auto Kad Softwaer and Photography
Intervention groups
1
Description
We used 3 gr Acasia Senegal Gum resolved in 20 ml pure water in control group for treatment of peristomal skin disorder in intervention group
Category
Treatment - Drugs
2
Description
For control group we cover 3 time a day all site of skin disorder with zinc oxide oitment and observed the skin wound healing
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Afsaneh Pirnia Naeini
Street address
Alzahra Hospital Standard and Evaluation Unit
City
Isfahan
2
Recruitment center
Name of recruitment center
Alzahra University Hospital
Full name of responsible person
Afsaneh Pirnia Naeini
Street address
Sofeh Avenue
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences .Vice chancellor for research
Full name of responsible person
Mr.Moradi
Street address
Isfahan University of Medical Sciences
City
Isfahan
Grant name
داراي كد تصويب طرح به شماره 287239به تاريخ22/2/1378
Grant code / Reference number
287239
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences .Vice chancellor for research
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
Isfahan University of Medical Sciences
Full name of responsible person
Afsaneh Pirnia Naeini
Position
Master of Nursing / Accreditation Standards in Hospital
Other areas of specialty/work
Street address
Sofeh street.Alzahra Hospital
City
Isfahan
Postal code
8174675731
Phone
+98 31 1668 5555
Fax
+98 31 1668 4510
Email
afsaneh@stu.kanazwa-u.ac.jp
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences.school of Nursing and Midwifery
Full name of responsible person
Ali Zargham Brogeni
Position
PHD of Nursing
Other areas of specialty/work
Street address
Hezar Jarib Street. Isfahan University. school of Nursing and Midwifery
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2964
Fax
+98 31 1624 7080
Email
zargham@nm.mui.ac.ir
Web page address
www.nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Alzahra Hospital
Full name of responsible person
Afsaneh Pirnia Naeini
Position
Master of Nursing
Other areas of specialty/work
Street address
Alzahra Hospital, Isfahan University of Medical Sciences, Hezar Jerib Street.
City
Isfahan
Postal code
81589-66331
Phone
+98 31 1668 5555
Fax
Email
afsaneh@stu.kanazawa-u.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)