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Completed

NCT Number: NCT04412759

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Burn Centre at Linköping University Hospital,

Linköping, 58185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

microbial cellulose

Other

polymer dressing synthesized in abundance with Acetobacter Xylinum

Primary outcomes

  1. Time to complete healing of the burn

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

    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 outcomes

  1. Burn wound infection

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

    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.
  2. Burn wound pain

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

    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.

  3. Duration of hospital stay (LOS)

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

    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.

  4. Burn scar outcome

    Time frame: Evaluated at six and 12 months after injury

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jun 2, 2020
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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