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

ConditionBurns
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Manitoba

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.)

  • 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).

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Standard dressingActive comparator 1 intervention
Group B: Test dressingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary outcome

Days to over 80% area of burn injury healed

Time frame
1-14 days

Secondary outcomes

1

Patient and caregiver satisfaction and perception of pain

Measure satisfaction and perception of pain using a survey

Time frame
At each dressing change
2

Proportion requiring surgery

Proportion of burn injuries that require skin grafting in each group

Time frame
1-14 days
3

Relative surface area skin grafted

Calculate area of burn needing grafting and area of burn that does not need graft

Time frame
1-14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Manitoba

Lead sponsor

Medline Industries

Collaborator