The biological dressing and conventional treatment in patients with massive burn: a clinical trial
ISRCTN | ISRCTN01055688 |
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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
Scientific
Shafieyeh Hospital
Karagran St
Zanjan
45138
Iran
nejat.hosini@zums.ac.ir |
Study information
Study design | Non randomised controlled trial |
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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 |
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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
45138
Iran
Sponsor information
Zanjan University of Medical Sciences (Iran)
University/education
University/education
Azadi Blvd
Zanjan
45154
Iran
nejat.hosini@zums.ac.ir | |
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 | |
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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? |
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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.