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

University Hospital, Linkoeping26 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Burns Burn Scar Burn Second Degree

Interventions

microbial celluloseOTHER

polymer dressing synthesized in abundance with Acetobacter Xylinum

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Burn Centre at Linköping University Hospital,

Linköping, Sweden

Outcomes

Primary Outcomes

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.

Time frame: Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: From admission until discharge, up to 6 months

Burn scar outcome

Data from ClinicalTrials.gov

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