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 designNon randomised controlled trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe biological dressing and conventional treatment in patients with massive burn: a clinical trial
Study acronymBiological dressing study
Study objectivesDue 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) studiedBurns
InterventionThe 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 typeOther
Primary outcome measure1. 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 measuresAlbumin and Fresh Frozen Plasma (FFP) intake.
Overall study start date01/10/2002
Completion date30/07/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants118 burns' patients
Total final enrolment118
Key inclusion criteriaThe patients had Total Body Surface Area (TBSA) between 30% to 75% due to scalds or flames.
Key exclusion criteriaNon-infected and non-chemical burns.
Date of first enrolment01/10/2002
Date of final enrolment30/07/2006

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.