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

Overview

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

Full Title of Study: “PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS – A RANDOMISED CLINICAL TRIAL”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2018

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.

Interventions

  • Other: microbial cellulose
    • polymer dressing synthesized in abundance with Acetobacter Xylinum

Arms, Groups and Cohorts

  • No Intervention: Porcine xenograft
    • porcine xenograft derived from dermal porcine skin. Standard of care treatement for partila thickness burn at the specfic centre
  • Experimental: Microbial cellulose
    • Novel dressing consisting of a biopolymer spun by the bacteria Acetobacter xylinum (later removed).

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Linkoeping
  • Provider of Information About this Clinical Study
    • Principal Investigator: Folke Sjoberg, Professor in burn care – University Hospital, Linkoeping

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.