Determination of the effect of Boswellia gel and hydrocolloid dressing on second and third degree pressure ulcer repair in hospitalized patient.
Design
This clinical trial has three groups. The groups are parallel, double-blinded, randomized, each group size is 25.
Settings and conduct
The research population are patients with second and third degree ulcer selected by simple sampling method. The place of intervention is Shahid Faghihi hospital of Shiraz. The number of patients in each group is 25. In this study, the wound assessor and patients are unaware of the type of intervention. Patients are treated for 35 days. The wounds are scored on the wound healing process on the first, 7th, 14th and 21th, 28th and 35th days.
Participants/Inclusion and exclusion criteria
Age over 18 years.
Second-degree and three-degree pressure ulcer.
Hospitalized patients.
Matched used antibiotics.
Not having inflammatory disease.
Intervention groups
The study consists of three groups:
First intervention group,They are treated with hydrocolloid dressing and Boswellia gel.
Second intervention group,They are treated with hydrocolloid dressing and Plasebo gel.
control group,They are treated with hydrocolloid dressing.
Main outcome variables
Size of the Bedsore; wound tissue score; amount of bedsore discharge; transforming growth factor beta 1 and beta 3
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181024041449N1
Registration date:2018-11-22, 1397/09/01
Registration timing:retrospective
Last update:2018-11-22, 1397/09/01
Update count:0
Registration date
2018-11-22, 1397/09/01
Registrant information
Name
ali hassanpourdehkordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3334 6720
Email address
alihassanpourdehkordi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-30, 1396/10/09
Expected recruitment end date
2018-07-05, 1397/04/14
Actual recruitment start date
2017-12-30, 1396/10/09
Actual recruitment end date
2018-07-05, 1397/04/14
Trial completion date
2018-07-05, 1397/04/14
Scientific title
Comparison the effect of Hydrocolloid dressing and Boswellia gel in healing of bed sore in patients.
Public title
Boswellia in wound healing.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having second and third grade of bed sore.
Age over 18 years.
Hospitalized patients.
Not having inflammatory disease.
Uniformity of antibiotic use.
Exclusion criteria:
Patient death.
Unwillingness to cooperate.
Skin allergy reaction.
Age
From 18 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
75
Actual sample size reached:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization.
Patients randomly take one card from inside a box in which are cards with letters A, B, C with the same number of samples.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient does not know that is in which group.
The evaluators are unaware of the type of intervention performed in the patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Shahrkord University Of Medical Sciences
Street address
University Of Medical Sciences, Rahmatie, Shahrkord Town.
City
Shahrkord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2017-09-10, 1396/06/19
Ethics committee reference number
IR.SKUMS.REC.1396.142
Health conditions studied
1
Description of health condition studied
Bed sore stage II
ICD-10 code
L89.1
ICD-10 code description
bed sore stage II
2
Description of health condition studied
Bed sore stage III
ICD-10 code
L89.2
ICD-10 code description
Bed sore stage III
Primary outcomes
1
Description
Pressure ulcer healing
Timepoint
At the beginning of the study, 7, 14, 21, 28 and 35 days after the beginning of dressing.
Method of measurement
Pressure Ulcer Scale for Healing, (PUSH TOOL)
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: On the first day of the intervention and days of 7, 14, 21, 28 and 35, patients are treated with Boswellia gel 5% and hydrocolloids dressing. During the above periods, the wounds are scored with the Push tools. At the end of the intervention, the wound healing process is evaluated by comparing the scores of the wounds.
Category
Treatment - Drugs
2
Description
Second Intervention group: On the first day of the intervention, 7, 14, 21, 28 and 35 were treated with placebo gel and hydrocolloids dressing. During the above periods, the wounds were scored with the Push tools. At the end of the intervention, the wound healing process is examined.
Category
Placebo
3
Description
Control group:On the first day of the intervention and 7, 14, 21, 28 and 35, patients are treated with hydrocolloids dressing. During the above periods, the wounds are scored with the Push tools. At the end of the intervention, the wound healing process is evaluated by comparing the scores of the wounds.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi Haspital
Full name of responsible person
Ali Hassanpour Dehkordi
Street address
Shiraz, Zand Blv, Shahid Faghihi Haspital.
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Fax
+98 71 3233 1634
Email
faghihihsp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Hassanpour Dehkordi
Street address
Shahrekord University Of Medical Sciences, Rahmatie, Shahrkord.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
info@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Hassanpour Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University Of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 0383333061
Email
Alihassanpourdehkordi@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Hassanpour Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University Of Medical Sciences,Rahmatie,Shahrekord.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
alihassanpourdehkordi@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ali Hassanpour Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University Of Medical Sciences, Rahmatie, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
alihassanpourdehkordi@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Observe the anonymity and confidentiality of the participants' information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available