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

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

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

Study Overview

• Status: Completed
• Conditions: Burn Scar; Burns; Burn Second Degree
• Intervention / Treatment: Other: microbial cellulose

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, 58185
    • The Burn Centre at Linköping University Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Other: microbial cellulose; polymer dressing synthesized in abundance with Acetobacter Xylinum

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): November 1, 2018
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (ACTUAL): June 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: MC-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No