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