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

Study Overview
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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.

Official Title
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PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS - A RANDOMISED CLINICAL TRIAL

Conditions
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Burns, Burn Scar, Burn Second Degree

Intervention / Treatment
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* Other: microbial cellulose


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Porcine xenograft<br>porcine xenograft derived from dermal porcine skin. Standard of care treatement for partila thickness burn at the specfic centre | |
| Experimental: Microbial cellulose<br>Novel dressing consisting of a biopolymer spun by the bacteria Acetobacter xylinum (later removed). | Other: microbial cellulose<br>* polymer dressing synthesized in abundance with Acetobacter Xylinum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months | 
| 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. | Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months | 
| 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. | From admission until discharge, up to 6 months | 
| 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. | Evaluated at six and 12 months after injury |