A randomised clinical trial comparing hydrocolloid, phenytoin and simple dressing in the treatment of pressure ulcer

ISRCTN ISRCTN33429693
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

No. 99
Physicians Building
Rooyan Alley
Next to Sassan Hospital
Keshavarz BLVD
Tehran
1415994978
Iran

Phone +98 (0)21 8964763
Email h_khedmat@hotmail.com

Study information

Study designRandomised single blind active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleA randomised clinical trial comparing hydrocolloid, phenytoin and simple dressing in the treatment of pressure ulcer
Study acronymSCI-HD-PC-SD
Study objectivesAdded 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) studiedPressure ulcer
InterventionThree therapeutic methods:
1. Simple dressing
2. Hydrocolloid dressing
3. Phenytoin cream
Intervention typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/03/2002
Completion date01/05/2002

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants83
Key inclusion criteriaCurrent 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 criteriaAdded 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 enrolment01/03/2002
Date of final enrolment01/05/2002

Locations

Countries of recruitment

  • Iran
  • Iraq

Study participating centre

No. 99
Tehran
1415994978
Iran

Sponsor information

Janbazan Medical and Engineering Research Centre (JMERC)
Research organisation

No. 25
Farrokh Alley
Moghadas Ardabili. St
Tehran
19615/616
Iran

Phone +98 (0)21 2412114
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 15/12/2004 Yes No

Editorial Notes

23/01/2020: Internal review.