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11 February 2012
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| [ Print-friendly version ] |
| A randomised clinical trial comparing hydrocolloid, phenytoin and simple dressing in the treatment of pressure ulcer |
| ISRCTN | ISRCTN33429693 |
| ClinicalTrials.gov identifier | |
| 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 |
| 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 |
| info@jmerc.ac.ir | |
| Date applied | 10/10/2004 |
| Last edited | 19/08/2009 |
| Date ISRCTN assigned | 18/10/2004 |
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| © 2012 ISRCTN unless otherwise stated. | |
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