A Between Patient Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries

NCT05000983 | Recruiting Phase 1 DMC

• 1 other identifier: between
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Burn injuries can result in long term physical and mental sequelae, not only from the scarring but also the painful dressings. The standard of care today remains use of antibiotic topical dressings while awaiting demarcation of the burn depth, with surgical excision and grafting for deep partial thickness and full thickness areas. Demarcation can be appreciated on admission for full thickness burns but is often a prolonged process that can last weeks. The clinical evaluation of the depth of the burn is a complex decision that often is made more challenging by the presence of the proteinaceous pseudoeschar and the coagulated dermis itself. Surgical debridement is relatively 'coarse' and by its very nature requires removal of a thin layer of viable tissue to reach the level that is vascularized enough to support a skin graft. There has been growing interest in the use of adjuncts to reduce the amount tissue debrided and potentially reduce the need for surgery itself. Operatively, there have been some reports that use of hydro-dissection devices (Versajet™) may allow a more controlled debridement, resulting in less viable tissue being sacrificed. There is also a growing experience with enzymatic debridement, especially with Bromolein, derived from Pineapple (NexoBrid®). Neither of these have been shown to definitively improve care in randomized controlled trials, (RCTs) and there is suggestion that in some settings may actually cause harm.

Conditions

Burns

Keywords

burn; wound; debridement

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  Days to over 80% area of burn injury healed

  1-14 days

Secondary Outcomes (3)

• Patient and caregiver satisfaction and perception of pain

  At each dressing change

• Proportion requiring surgery

  1-14 days

• Relative surface area skin grafted

  1-14 days

Study Arms (2)

Standard dressing

ACTIVE COMPARATOR

Topical antibiotic ointment (Polysporin™ or formulary equivalent) and non-adherent petrolatum fine-meshed gauze (ADAPTIC™) applied every Monday, Wednesday and Friday (or equivalent).

Drug: Standard dressing

Test dressing

EXPERIMENTAL

A 0.5 cm layer of PluroGel® followed by the above standard dressing. In addition, this will be covered with moistened gauze, kept moist twice daily. (The additional factors are the use of PluroGel® and moistened gauze. Standard dressing will continue to be used.)

Drug: PluroGel

Interventions

PluroGel DRUG

A 0.5 cm layer of PluroGel® followed by the above standard dressing. In addition, this will be covered with moistened gauze, kept moist twice daily. (The additional factors are the use of PluroGel® and moistened gauze. Standard dressing will continue to be used.)

Test dressing

Standard dressing DRUG

Topical antibiotic ointment (Polysporin™ or formulary equivalent) and non-adherent petrolatum fine-meshed gauze (ADAPTIC™) applied every Monday, Wednesday and Friday (or equivalent).

Standard dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons with partial thickness face burns or unilateral limb burn injuries requiring admission.

You may not qualify if:

• Total burn surface area (TBSA) \>30%.
• Burn depth full thickness or deeper on initial assessment.
• Prior excision at another healthcare centre.
• Patients with pre-existing malnutrition
• Electrical, chemical or other unusual burn etiologies

Sponsors & Collaborators

• University of Manitoba: lead
• Medline Industries: collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

MeSH Terms

Conditions

Burns; Wounds and Injuries

Central Study Contacts

Justin Gawaziuk, MSc

CONTACT

2047878682; jgawaziuk@hsc.mb.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: August 11, 2021
• Study Start: October 20, 2021
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)