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

Sponsor

University Hospital, Linkoeping (Other)

Overall Status

Completed

CT.gov ID

NCT04412759

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Burns Burn Scar Burn Second Degree	Other: microbial cellulose	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Nov 1, 2018

Actual Study Completion Date :

Nov 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Time to complete healing of the burn [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 Outcome Measures

Burn wound infection [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 [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) [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Burn Centre at Linköping University Hospital,	Linköping		Sweden	58185

Sponsors and Collaborators

University Hospital, Linkoeping

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Folke Sjoberg, Professor in burn care, University Hospital, Linkoeping

ClinicalTrials.gov Identifier:

NCT04412759

Other Study ID Numbers:

MC-2015

First Posted:

Jun 2, 2020

Last Update Posted:

Jun 2, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Burns

Study Results

No Results Posted as of Jun 2, 2020