Condition category
Skin and Connective Tissue Diseases
Date applied
10/10/2004
Date assigned
18/10/2004
Last edited
19/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hossein Khedmat

ORCID ID

Contact details

No. 99
Physicians Building
Rooyan Alley
Next to Sassan Hospital
Keshavarz BLVD
Tehran
1415994978
Iran
+98 (0)21 8964763
h_khedmat@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

258147739

Study information

Scientific title

Acronym

SCI-HD-PC-SD

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.

Ethics approval

Not provided at time of registration

Study design

Randomised single blind active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Pressure ulcer

Intervention

Three therapeutic methods:
1. Simple dressing
2. Hydrocolloid dressing
3. Phenytoin cream

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/03/2002

Overall trial end date

01/05/2002

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

83

Participant 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)

Recruitment start date

01/03/2002

Recruitment end date

01/05/2002

Locations

Countries of recruitment

Iran, Iraq

Trial participating centre

No. 99
Tehran
1415994978
Iran

Sponsor information

Organisation

Jaonbazan Medical and Engineering Research Centre (Iran)

Sponsor details

No. 25
Farrokh Alley
Moghadas Ardabili. St
Tehran
19615/616
Iran
+98 (0)21 2412114
info@jmerc.ac.ir

Sponsor type

Research organisation

Website

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15601464

Publication citations

  1. Results

    Hollisaz MT, Khedmat H, Yari F, A randomized clinical trial comparing hydrocolloid, phenytoin and simple dressings for the treatment of pressure ulcers [ISRCTN33429693]., BMC Dermatol., 2004, 4, 1, 18, doi: 10.1186/1471-5945-4-18.

Additional files

Editorial Notes