Pressure ulcer Skin and Connective Tissue Diseases Decubitus ulcer
Conditions
Interventions
Three therapeutic methods:
1. Simple dressing
2. Hydrocolloid dressing
3. Phenytoin cream
Sponsors
Janbazan Medical and Engineering Research Centre (JMERC)
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
Iran, Iraq
Outcome results
None listed