A Phase 1/2 interventional study of Standard dressing and PluroGel in Burns, sponsored by University of Manitoba. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University of Manitoba · Phase 1/2, Interventional, and Treatment
Among 42 studies in Burns with a site in Canada — 14 open to participants now, 15 under way, 1 of them phase 3. Burns · Canada.
Among the 42 studies in Burns with a site in Canada, this one is the 23rd largest by planned enrollment of the 36 interventional ones that give a count, is one of 6 that started in 2021, is one of 4 in phase 1/2, reaches primary completion later than 13 of the 14 other live ones, and was the 33rd registered.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
Browse Burns studies →14 of the 42 studies in Burns with a site in Canada are open now. Recruiting first, the newest first:
Birch BioMed Inc · Sites in Canada
St. Justine's Hospital · Sites in Canada
University of Manitoba · Sites in Canada
University of Manitoba · Sites in Canada
CHU de Quebec-Universite Laval · Sites in Canada
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 84 Burns studies recruiting now, 38 (45%) set no upper age limit and 37 (44%) stop at 75 or younger; 17 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
42 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 9 · Phase 3 4 · Phase 4 3
First in 2005; this study’s year is marked. 6 started in 2021.
This study's planned enrollment of 20 is below the median of 40 across 663 interventional studies indexed under Burns.
Median enrollment 30 across the 36 interventional studies, 40 across the 5 observational. Of the 21 that completed or were terminated, 1 (5%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 42 have an industry lead sponsor. The 10 most frequent:
University of Manitoba is the lead sponsor of 555 studies on the registry; 89 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
University of Manitoba has 7 studies filed under Burns — fewer than ten, so there is no comparison to draw.
2 of the studies in Burns with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06807021Phase 3Birch BioMed IncPost-Operative Use of FS2 to Mitigate Scarring in Burn Patients | 2027-09 |
| NCT07850557Centre hospitalier de l'Université de Montréal (CHUM)Hypertrophic Scar Prosthetic Pressure in Burn Amputee | 2026-12-31 |
Among the 42 studies in Burns with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
A relatively recent entry into the 'space' of non-surgical burn wound debridement is Plurogel®. Unlike Bromolein, Plurogel® is a concentrated surfactant in the form of a stable, viscous gel. Each micelle has a hydrophilic outer surface that softens and loosens wound debris, and a hydrophobic inner core that traps debris. The micelles link to form a matrix that continually expands and contracts. This creates a cleansing/rinsing action that disrupts the surface tension holding slough and necrotic tissue in place. PluroGel® helps in creating a moist wound healing environment, which softens, loosens and drives slough and necrotic debris away from the wound bed, promoting autolytic debridement. PluroGel® is approved for use in burn injuries in Canada, however there are no randomized control trials (RCTs) to support its use. As Plurogel® appears to fill a much-needed niche in burn wound care, and as our centre seeks to be innovative in patient care, we trialed Plurogel® on some of our appropriately consented burn patients. The anecdotal experience is that the eschar lifted within about a week and there was visible wound healing. Healing time appeared to be reduced as the product would gently debride while still providing a moist wound bed encouraging wound healing. Team members began to value the new product. This early positive experience is the impetus for us to embark on a pilot RCT to provide evidence for us to continue to use this product.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
Topical antibiotic ointment (Polysporin™ or formulary equivalent) and non-adherent petrolatum fine-meshed gauze (ADAPTIC™) applied every Monday, Wednesday and Friday (or equivalent).
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.)
Proportion healed
Proportion of burn requiring skin grafting (grafted cm2/ total burn area on that limb cm2) compared between a standard dressing limb and a PluroGel® treated limb.
Time frame: 14 days
Proportion requiring surgery
Proportion of burn injuries that require skin grafting in each group.
Time frame: 14 days
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2021 (actual). Primary completion is estimated for Dec 2028, 86 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.