PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS

NCT ID: NCT04412759

Last Updated: 2020-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-11-30

Brief Summary

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The purpose of this study was to compare two wound dressing products for partial thickness burns in adults.

Detailed Description

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After being informed about the study, all patients that had given written informed consent underwent screening. If eligible study participants were randomized to be treated wih either the standard dressing of care; pigskin or a microbial cellulose. Dressing were applied within 72 hours after burn injury. Evaluation was done in an open manner due to the specific characteristics of the dressings. Study particpants were followed weekly until complete wound closure and after that evaluated at 6 and 12 months after injruy for burn scar outcome.

Conditions

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Burns Burn Scar Burn Second Degree

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Porcine xenograft

porcine xenograft derived from dermal porcine skin. Standard of care treatement for partila thickness burn at the specfic centre

Group Type NO_INTERVENTION

No interventions assigned to this group

Microbial cellulose

Novel dressing consisting of a biopolymer spun by the bacteria Acetobacter xylinum (later removed).

Group Type EXPERIMENTAL

microbial cellulose

Intervention Type OTHER

polymer dressing synthesized in abundance with Acetobacter Xylinum

Interventions

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microbial cellulose

polymer dressing synthesized in abundance with Acetobacter Xylinum

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Study participants admitted within 72 hours of injury
* partial-thickness burns requiring a temporary skin cover
* written informed consent

Exclusion Criteria

* severe coexisting cutaneous trauma
* chronic or current skin disease,
* severe cognitive dysfunction or psychiatric disorder
* pregnant or breast feeding women were excluded.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

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Folke Sjoberg

Professor in burn care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Burn Centre at Linköping University Hospital,

Linköping, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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MC-2015

Identifier Type: -

Identifier Source: org_study_id

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