A randomised clinical trial comparing hydrocolloid, phenytoin and simple dressing in the treatment of pressure ulcer
Not Applicable
Completed
- Conditions
- Pressure ulcerSkin and Connective Tissue DiseasesDecubitus ulcer
- Registration Number
- ISRCTN33429693
- Lead Sponsor
- Janbazan Medical and Engineering Research Centre (JMERC)
- Brief Summary
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15601464
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 83
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Ulcer healing<br> 1.1 Complete ulcer healing, defined as:<br> 1.1.1. For stage I ulcer, intact epidermis, no red area<br> 1.1.2. For stage II ulcers, intact dermis and epidermis, no abrasion or ulceration.<br> 1.2. Partial healing, defined as any decrease in ulcer size compared to the baseline ulcer tracing, excluding complete healing<br> 1.3. Without improvement, defined as no change in ulcer size compared to the baseline ulcer tracing<br> 1.4. Worsening, defined as any increase in ulcer size compared to the baseline ulcer tracing.<br> 2. Response rate<br>
- Secondary Outcome Measures
Name Time Method ot provided at time of registration