1. Home
  2. Approved trials
  3. » فارسی

Evaluation of effects of calcipotriol ointment on healing of split thickness skin graft donor site: a single blind controlled trial

Protocol summary

Study aim
Evaluation of effects of calcipotriol ointment on healing of the split thickness skin graft donor site
Design
Parallel group, single blind, randomized controlled trial
Settings and conduct
This study is a randomized single blind clinical trial which will be conducted in a burn ward of a teaching hospital. In patients that have two different donor sites each site will randomly assigned to the intervention or control group. In patients that have one donor site each half will be assigned to the intervention or control group. Outcomes will be assessed three, six, eight and ten days after the intervention. Assessor of the primary and secondary outcomes and Data analyzer will not have any information about the allocation of donor sites to each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients older than 18 years old who sign informed consent form will be recruited. Exclusion criteria: donor site infection or bleeding; hypercalcemia; hyperphosphatemia; renal failure, hepatic impairment; sepsis; pregnancy and lactation
Intervention groups
Intervention group: Beside standard cares, the calcipotriol ointment 0.005% will be applied topically on the donor site every other day for ten days. Control group: Participants will only receive the daily standard cares of the donor site for ten days.
Main outcome variables
Percent of epithelialization of the donor site; Number of episodes of infection and bleeding of the donor site

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150609022637N5
Registration date: 2018-08-27, 1397/06/05
Registration timing: registered_while_recruiting

Last update: 2018-08-27, 1397/06/05
Update count: 0
Registration date
2018-08-27, 1397/06/05
Registrant information
Name
Naemeh Nikvarz
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5017
Email address
nnikvarz@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effects of calcipotriol ointment on healing of split thickness skin graft donor site: a single blind controlled trial
Public title
Evaluation of effects of calcipotriol ointment on healing of skin graft donor site
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergo split thickness skin graft Patients sign informed consent form
Exclusion criteria:
Infection of the donor site Bleeding of the donor site Pregnancy Lactation Hypercalcemia Hyperphosphatemia Renal failure Hepatic impairment Sepsis
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 48
More than 1 sample in each individual
Number of samples in each individual: 2
If Participants have two symmetric donor sites (e.g. left and right thigh), one of the donor sites will be allocated to the intervention group and the other site will be allocated to the control group. If participants have only one donor site, one-half of the site will be allocated to the intervention group and the other half will be allocated to the control group.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The investigator who inspect the donor site regarding infection, bleeding and healing will be blinded in the following way: patient or one of his/her caregivers will apply the ointment every other day at morning. On the third day the donor site will be evaluated 4 to 6 hours after the ointment application, when the ointment has completely been absorbed and the intervention and control sites will not be different in this regard. The other times of the evaluation will be one day after the application of the ointment. َAgain the ointment has completely been absorbed and the intervention and control sites will not be different in this regard. Investigator who will statistically analyze data will not have any information about the source (intervention or control group) of data. Other investigators, patients and nurses will not be blinded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Office of the Vice Chancellor for Research, Ebne-sina Ave, Jahad Blvd
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2018-05-28, 1397/03/07
Ethics committee reference number
IR.KMU.REC.1397.060

Health conditions studied

1

Description of health condition studied
Burn injury
ICD-10 code
T30
ICD-10 code description
Burn and corrosion, body region unspecified

Primary outcomes

1

Description
Percent of epithelialization of the donor site
Timepoint
10 days after the intervention
Method of measurement
Calculation of the ratio of the surface area of the epithelialized parts to the total surface area of the donor site

Secondary outcomes

1

Description
Number of episodes of the donor site infection
Timepoint
Before the intervention and 3, 6, 8 and 10 days after the intervention
Method of measurement
Inspection of the donor site and/or microbial culture of wound secretions

2

Description
Number of episodes of the donor site bleeding
Timepoint
Before the intervention and 3, 6, 8 and 10 days after the intervention
Method of measurement
Inspection of the donor site

Intervention groups

1

Description
Intervention group: Calcipotriol ointment 0.005% (Tehran Shimi Company) will be applied topically on the donor site every other day for 10 days.
Category
Treatment - Drugs

2

Description
Control group: No intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Ali Parand
Street address
Shafa hospital, Shafa Ave., Jomhoori Blvd.
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
parand.a@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Office of the Vice Chancellor for Research, Ebne-sina Ave., Jahad Blvd.
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Naemeh Nikvarz
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Clinical pharmacy
Street address
Pradis of Kerman University of Medical Sciences, Haft Bagh Road
City
Kerman
Province
Kerman
Postal code
7616911319
Phone
+98 34 3132 5017
Email
nnikvarz@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Naemeh Nikvarz
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Clinical pharmacy
Street address
Pardis of Kerman University of Medical Sciences, Haft bagh Road
City
Kerman
Province
Kerman
Postal code
7616911319
Phone
+98 34 3132 5017
Email
nnikvarz@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Naemeh Nikvarz
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Clinical pharmacy
Street address
Pardis of Kerman Unuversity of Medical Sciences, Haft bagh Road
City
Kerman
Province
Kerman
Postal code
7616911319
Phone
+98 34 3132 5017
Fax
+98 34 3132 5003
Email
nnikvarz@kmu.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
There is no further information.
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
Not applicable
Data Dictionary
Not applicable
Loading...