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A randomised clinical trial comparing hydrocolloid, phenytoin and simple dressing in the treatment of pressure ulcer
ISRCTN ISRCTN33429693
DOI 10.1186/ISRCTN33429693
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised clinical trial comparing hydrocolloid, phenytoin and simple dressing in the treatment of pressure ulcer
Scientific title
Acronym SCI-HD-PC-SD
Serial number at source 258147739
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.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised single blind active controlled parallel group trial
Countries of recruitment Iran, Iraq
Disease/condition/study domain Pressure ulcer
Participants - 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
Participants - 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)
Anticipated start date 01/03/2002
Anticipated end date 01/05/2002
Status of trial Completed
Patient information material
Target number of participants 83
Interventions Three therapeutic methods:
1. Simple dressing
2. Hydrocolloid dressing
3. Phenytoin cream
Primary outcome measure(s) 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 measure(s) Not provided at time of registration
Sources of funding Not provided at time of registration
Trial website
Publications 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15601464
Contact name Prof  Hossein  Khedmat
  Address No. 99
Physicians Building
Rooyan Alley
Next to Sassan Hospital
Keshavarz BLVD
  City/town Tehran
  Zip/Postcode 1415994978
  Country Iran
  Tel +98 (0)21 8964763
  Fax +98 (0)21 8037560
  Email h_khedmat@hotmail.com
Sponsor Jaonbazan Medical and Engineering Research Centre (Iran)
  Address No. 25
Farrokh Alley
Moghadas Ardabili. St
  City/town Tehran
  Zip/Postcode 19615/616
  Country Iran
  Tel +98 (0)21 2412114
  Fax +98 (0)21 2412502
  Email info@jmerc.ac.ir
Date applied 10/10/2004
Last edited 19/08/2009
Date ISRCTN assigned 18/10/2004
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