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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412759
• Other study ID #: MC-2015
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: November 2019

Study information

• Verified date: May 2020
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burn Scar
• Burn Second Degree
• Burns

Intervention

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

Locations

Country	Name	City	State
Sweden	The Burn Centre at Linköping University Hospital,	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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