The biological dressing and conventional treatment in patients with massive burn: a clinical trial

ISRCTN	ISRCTN01055688
DOI	https://doi.org/10.1186/ISRCTN01055688
Secondary identifying numbers	289-zanjan university of medical sciences

Submission date: 17/08/2006
Registration date: 25/09/2006
Last edited: 07/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Seyednejat Hosseini
Scientific

Shafieyeh Hospital
Karagran St
Zanjan
45138
Iran

Email	nejat.hosini@zums.ac.ir

Study information

Study design	Non randomised controlled trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	The biological dressing and conventional treatment in patients with massive burn: a clinical trial
Study acronym	Biological dressing study
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/10/2002
Completion date	30/07/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	118 burns' patients
Total final enrolment	118
Key inclusion criteria	The patients had Total Body Surface Area (TBSA) between 30% to 75% due to scalds or flames.
Key exclusion criteria	Non-infected and non-chemical burns.
Date of first enrolment	01/10/2002
Date of final enrolment	30/07/2006

Locations

Countries of recruitment

Iran

Study participating centre

Shafieyeh Hospital

Zanjan
45138
Iran

Sponsor information

Zanjan University of Medical Sciences (Iran)
University/education

Azadi Blvd
Zanjan
45154
Iran

Email	nejat.hosini@zums.ac.ir
"ROR"	https://ror.org/01xf7jb19

Funders

Funder type

University/education

A grant from Zanjan University of Medical Sciences (Iran)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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	01/03/2009	07/01/2021	Yes	No

Editorial Notes

07/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.