Burns Clinical Trial
Official title:
PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS - A RANDOMISED CLINICAL TRIAL
NCT number | NCT04412759 |
Other study ID # | MC-2015 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | November 2019 |
Verified date | May 2020 |
Source | University Hospital, Linkoeping |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study was to compare two wound dressing products for partial thickness burns in adults.
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | The Burn Centre at Linköping University Hospital, | Linköping |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Linkoeping |
Sweden,
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 |
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