A randomised clinical trial comparing hydrocolloid, phenytoin and simple dressing in the treatment of pressure ulcer
ISRCTN | ISRCTN33429693 |
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DOI | https://doi.org/10.1186/ISRCTN33429693 |
Secondary identifying numbers | 258147739 |
- Submission date
- 10/10/2004
- Registration date
- 18/10/2004
- Last edited
- 23/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Hossein Khedmat
Scientific
Scientific
No. 99
Physicians Building
Rooyan Alley
Next to Sassan Hospital
Keshavarz BLVD
Tehran
1415994978
Iran
Phone | +98 (0)21 8964763 |
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h_khedmat@hotmail.com |
Study information
Study design | Randomised single blind active controlled parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Treatment |
Scientific title | A randomised clinical trial comparing hydrocolloid, phenytoin and simple dressing in the treatment of pressure ulcer |
Study acronym | SCI-HD-PC-SD |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Pressure ulcer |
Intervention | Three therapeutic methods: 1. Simple dressing 2. Hydrocolloid dressing 3. Phenytoin cream |
Intervention type | Other |
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 study start date | 01/03/2002 |
Completion date | 01/05/2002 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Male |
Target number of participants | 83 |
Key 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 |
Key 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) |
Date of first enrolment | 01/03/2002 |
Date of final enrolment | 01/05/2002 |
Locations
Countries of recruitment
- Iran
- Iraq
Study participating centre
No. 99
Tehran
1415994978
Iran
1415994978
Iran
Sponsor information
Janbazan Medical and Engineering Research Centre (JMERC)
Research organisation
Research organisation
No. 25
Farrokh Alley
Moghadas Ardabili. St
Tehran
19615/616
Iran
Phone | +98 (0)21 2412114 |
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info@jmerc.ac.ir |
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 15/12/2004 | Yes | No |
Editorial Notes
23/01/2020: Internal review.