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
Protocol serial number	258147739
Sponsor	Janbazan Medical and Engineering Research Centre (JMERC)
Funder	Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised single blind active controlled parallel group trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/05/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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.