Contact information
Type
Scientific
Primary contact
Prof Hossein Khedmat
ORCID ID
Contact details
No. 99
Physicians Building
Rooyan Alley
Next to Sassan Hospital
Keshavarz BLVD
Tehran
1415994978
Iran
+98 (0)21 8964763
h_khedmat@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
258147739
Study information
Scientific title
A randomised clinical trial comparing hydrocolloid, phenytoin and simple dressing in the treatment of pressure ulcer
Acronym
SCI-HD-PC-SD
Study hypothesis
Added 19/08/09:
In Iran, 5000 patients suffer from spinal cord injury (SCI): of these, 2000 are lran-lraq war victims and 3000 were handicapped by other causes. In view of the enormous prevalence of pressure ulcers in war victims and other spinal handicap patients, and the importance of these lesions in terms of morbidity, mortality and cost of treatment, we have compared the efficacies of applying hydrocolloid dressing, phenytoin cream and a simple dressing. The aims were to determine: 1. which is the most effective in terms of complete ulcer healing; 2. whether healing rates differ with respect to the ulcer stage (I and II) or location (gluteal, ischial, sacral) using these three different methods.
As of 19/08/09 this record has been extensively updated. All updates can be found under the relevant field with the above update date.
Ethics approval
Not provided at time of registration
Study design
Randomised single blind active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Pressure ulcer
Intervention
Three therapeutic methods:
1. Simple dressing
2. Hydrocolloid dressing
3. Phenytoin cream
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Ulcer healing
1.1 Complete ulcer healing, defined as:
1.1.1. For stage I ulcer, intact epidermis, no red area
1.1.2. For stage II ulcers, intact dermis and epidermis, no abrasion or ulceration.
1.2. Partial healing, defined as any decrease in ulcer size compared to the baseline ulcer tracing, excluding complete healing
1.3. Without improvement, defined as no change in ulcer size compared to the baseline ulcer tracing
1.4. Worsening, defined as any increase in ulcer size compared to the baseline ulcer tracing.
2. Response rate
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/03/2002
Overall trial end date
01/05/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current information as of 19/08/09:
1. Paraplegia caused by spinal cord injury
2. Pressure ulcer stage I and II according to Shea classification or National Pressure Ulcer Advisory Panel
3. Patient's informed consent
4. Smoothness of ulcer area to establish whether adhesive could be used at the site
Initial information at time of registration:
83 spinal cord victims of IRAN-IRAQ with pressure ulcer
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
83
Participant exclusion criteria
Added 19/08/09:
1. Addiction
2. Heavy smoking (more than 20 cigarettes a day or more than 10 packs per year
3. Concomitant chronic disease (e.g. diabetes mellitus or frank vascular disease such as Buerger's disease)
Recruitment start date
01/03/2002
Recruitment end date
01/05/2002
Locations
Countries of recruitment
Iran, Iraq
Trial participating centre
No. 99
Tehran
1415994978
Iran
Sponsor information
Organisation
Janbazan Medical and Engineering Research Centre (JMERC)
Sponsor details
No. 25
Farrokh Alley
Moghadas Ardabili. St
Tehran
19615/616
Iran
+98 (0)21 2412114
info@jmerc.ac.ir
Sponsor type
Research organisation
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15601464
Publication citations
-
Results
Hollisaz MT, Khedmat H, Yari F, A randomized clinical trial comparing hydrocolloid, phenytoin and simple dressings for the treatment of pressure ulcers [ISRCTN33429693]., BMC Dermatol., 2004, 4, 1, 18, doi: 10.1186/1471-5945-4-18.