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

Primary Purpose

Burns, Burn Scar, Burn Second Degree

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
microbial cellulose
Sponsored by
University Hospital, Linkoeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Burn Centre at Linköping University Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Porcine xenograft

Microbial cellulose

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Burn wound infection
Wound infections were diagnosed (by the burn surgeon) if they fulfilled at least two of the following criteria: (based on the American Burn Association definition of burn wound infection) Clinical signs such as localised pain and swelling, spreading erythema, and heat at the affected site. Positive bacterial culture growth of the surface wound swab. Signs of systemic infection indicated by a rise in CRP concentration (reference range < 10 mg/L for capillary sampling) together with increased body temperature where other sources of infection have been excluded.
Burn wound pain
The patients were asked to estimate the burn wound pain at rest, during activity, and during dressing changes using a numerical rating scale (NRS) where 0 indicated no pain and 10 the worst pain ever imaginable.
Duration of hospital stay (LOS)
All patients hospitalized for their burns were monitored by the study nurse and the day of discharge was noted in the CRF. Any readmission after initial discharge was also noted and included in the total length of stay.
Burn scar outcome
Burn scar outcome was evaluated using the Patient Observer Scar Assessment Scale (POSAS). The scale includes two separate subscales, The Observer Sscale, used by an experienced burn occupational therapist and the Patient Sscale, used by the study participants.

Full Information

First Posted
May 29, 2020
Last Updated
May 29, 2020
Sponsor
University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT04412759
Brief Title
PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS
Official Title
PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS - A RANDOMISED CLINICAL TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Burn Scar, Burn Second Degree

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Porcine xenograft
Arm Type
No Intervention
Arm Description
porcine xenograft derived from dermal porcine skin. Standard of care treatement for partila thickness burn at the specfic centre
Arm Title
Microbial cellulose
Arm Type
Experimental
Arm Description
Novel dressing consisting of a biopolymer spun by the bacteria Acetobacter xylinum (later removed).
Intervention Type
Other
Intervention Name(s)
microbial cellulose
Intervention Description
polymer dressing synthesized in abundance with Acetobacter Xylinum
Primary Outcome Measure Information:
Title
Time to complete healing of the burn
Description
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.
Time Frame
Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
Secondary Outcome Measure Information:
Title
Burn wound infection
Description
Wound infections were diagnosed (by the burn surgeon) if they fulfilled at least two of the following criteria: (based on the American Burn Association definition of burn wound infection) Clinical signs such as localised pain and swelling, spreading erythema, and heat at the affected site. Positive bacterial culture growth of the surface wound swab. Signs of systemic infection indicated by a rise in CRP concentration (reference range < 10 mg/L for capillary sampling) together with increased body temperature where other sources of infection have been excluded.
Time Frame
Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
Title
Burn wound pain
Description
The patients were asked to estimate the burn wound pain at rest, during activity, and during dressing changes using a numerical rating scale (NRS) where 0 indicated no pain and 10 the worst pain ever imaginable.
Time Frame
Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
Title
Duration of hospital stay (LOS)
Description
All patients hospitalized for their burns were monitored by the study nurse and the day of discharge was noted in the CRF. Any readmission after initial discharge was also noted and included in the total length of stay.
Time Frame
From admission until discharge, up to 6 months
Title
Burn scar outcome
Description
Burn scar outcome was evaluated using the Patient Observer Scar Assessment Scale (POSAS). The scale includes two separate subscales, The Observer Sscale, used by an experienced burn occupational therapist and the Patient Sscale, used by the study participants.
Time Frame
Evaluated at six and 12 months after injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The Burn Centre at Linköping University Hospital,
City
Linköping
ZIP/Postal Code
58185
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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

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