Recruiting
Phase 1
Phase 2

Plurogel®

Sponsor:

University of Manitoba

Code:

NCT04893863

Conditions

Burns

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard dressing

PluroGel

Study Details

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

Study ID

NCT04893863

Start date

Oct 1, 2021

Status verified date

May, 2026

Completion date

Jun 1, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Persons with bilateral limb partial thickness burn injuries of similar depth requiring admission

Exclusion Criteria:

  • Total body surface area (TBSA) of burn >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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard dressing

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

experimental: Test dressing

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.)

Interventions

Standard dressing

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

PluroGel

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.)

Primary outcome measure

  • Proportion healed [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3A 1R9

Contacts

Justin P Gawaziuk, MSc

2047873669jgawaziuk@hsc.mb.ca

Principal Investigator:

Sarvesh Logsetty, MD

More Information

Sponsor

University of Manitoba

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • burn
  • wound
  • dressing
  • debridement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-05-14.