Condition category
Injury, Occupational Diseases, Poisoning
Date applied
17/08/2006
Date assigned
25/09/2006
Last edited
25/09/2006
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

Dr Seyednejat Hosseini

ORCID ID

Contact details

Shafieyeh Hospital
Karagran St
Zanjan
45138
Iran
nejat.hosini@zums.ac.ir

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

289-zanjan university of medical sciences

Study information

Scientific title

Acronym

Biological dressing study

Study hypothesis

Due to less experience in use of biological dressing in the developing country, the aim of this study was to compare the outcome of biological dressing and conventional treatment in patients with massive burns.

Ethics approval

This study was approved by the ethics committee of Zanjan University of Medical sciences (2003) and all patients gave informed consent before entering into the study.

Study design

Non randomised controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Burns

Intervention

The patients were divided into two groups:
1. Those in the first group (conventional treatment) did not have satisfying wounds for treatment with biological dressings. This group were treated by daily washing, removal of loose dead tissue and topical application of saline soaked dressing. When the granulating bed became free of debris and uninfected, Split Thickness Skin Grafts (STSG) were applied usually after two to eight weeks.
2. The second group (biological dressings) had wounds that were satisfying and interesting for treatment with biological dressing (xenoderm). Xenoderm is a lyophilised pig skin, manufactured by MBP (Medical Biomaterial Product, Germany). First, xenoderm was prepared in normal saline solution and after debridement of the burned place with dermatome (tangential excision) and rinsing the wound with normal saline, xenoderm was placed on the wound by the surgeon (the author and colleagues) and fixed using suture, dressing or bandage and the organ immobilised by splint if necessary. Twenty four hours after surgery, dressing was opened. For full thickness area after two to eight weeks xenoderm was removed and STSG was performed.
All patients received cefazolin prophylaxes.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Mechanism of injury
2. TBSA
3. Total hospital stay
4. Amount of serum until started per oral feeding use
5. Number of oral or injectable analgesic intake
6. The number of dressing association with inhalation injury
7. Mortality

Secondary outcome measures

Albumin and Fresh Frozen Plasma (FFP) intake.

Overall trial start date

01/10/2002

Overall trial end date

30/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

The patients had Total Body Surface Area (TBSA) between 30% to 75% due to scalds or flames.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

118 burns' patients

Participant exclusion criteria

Non-infected and non-chemical burns.

Recruitment start date

01/10/2002

Recruitment end date

30/07/2006

Locations

Countries of recruitment

Iran

Trial participating centre

Shafieyeh Hospital
Zanjan
45138
Iran

Sponsor information

Organisation

Zanjan University of Medical Sciences (Iran)

Sponsor details

Azadi Blvd
Zanjan
45154
Iran
nejat.hosini@zums.ac.ir

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

A grant from Zanjan University of Medical Sciences (Iran)

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

Publication citations

Additional files

Editorial Notes