PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS
1 other identifier
interventional
26
1 country
1
Brief Summary
The purpose of this study was to compare two wound dressing products for partial thickness burns in adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 29, 2020
CompletedFirst Posted
Study publicly available on registry
June 2, 2020
CompletedJune 2, 2020
May 1, 2020
2.4 years
May 29, 2020
May 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Time to complete healing of the burn
Healing time was calculated from the date of injury to the date when the wound bed was assessed as completely (100 %) re-epithelialized, with no need for further dressing changes other than protection against shearing according to the treating physician.
Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
Secondary Outcomes (4)
Burn wound infection
Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
Burn wound pain
Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
Duration of hospital stay (LOS)
From admission until discharge, up to 6 months
Burn scar outcome
Evaluated at six and 12 months after injury
Study Arms (2)
Porcine xenograft
NO INTERVENTIONporcine xenograft derived from dermal porcine skin. Standard of care treatement for partila thickness burn at the specfic centre
Microbial cellulose
EXPERIMENTALNovel dressing consisting of a biopolymer spun by the bacteria Acetobacter xylinum (later removed).
Interventions
polymer dressing synthesized in abundance with Acetobacter Xylinum
Eligibility Criteria
You may qualify if:
- Study participants admitted within 72 hours of injury
- partial-thickness burns requiring a temporary skin cover
- written informed consent
You may not qualify if:
- severe coexisting cutaneous trauma
- chronic or current skin disease,
- severe cognitive dysfunction or psychiatric disorder
- pregnant or breast feeding women were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Burn Centre at Linköping University Hospital,
Linköping, 58185, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in burn care
Study Record Dates
First Submitted
May 29, 2020
First Posted
June 2, 2020
Study Start
June 1, 2016
Primary Completion
November 1, 2018
Study Completion
November 1, 2019
Last Updated
June 2, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share