A Randomized Controlled Trial Comparing Suprathel Versus Xeroform for the Management of Pediatric and Adult Split Thickness Skin Graft Donor Sites
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Burns
- Sponsor
- University of Colorado, Denver
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Pain Before Dressing Change as assessed by r-FLACC
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
The investigators aim to study whether Suprathel, a synthetic temporary skin substitute developed by PolyMedics Innovations GmBH aids in the management of patient pain and wound healing when compared to the current standard dressing used of a primary Xeroform dressing.
Detailed Description
Acute burn and donor site dressing changes are among the most traumatic and painful procedures performed on awake children and adults (7, 8). As a result, it is important to utilize dressings that: 1) stabilize open burn wounds and donor sites; 2) limit the frequency of dressing changes; 3) optimize burn wound and donor site healing; and 4) minimize scarring. Anecdotal evidence and a growing body of literature suggest that Suprathel may offer superior pain control and a decreased frequency of dressing changes, when compared to Xeroform. At Children's Hospital Colorado, the standard of care is to use Xeroform to dress split thickness skin grafts and donor sites. Xeroform is an inexpensive, bacteriostatic, non-adherent petroleum gauze dressing that is supplied in strips, sheets and rolls. It is used to protect freshly skin grafted areas and donor sites, it is then covered with gauze followed by BandNet. When Xeroform is applied to a split thickness donor site, it adheres to the open wound bed, where it is allowed to dry out. As the donor site heals, the Xeroform begins to separate from the wound bed, until the Xeroform eventually sloughs off. Suprathel is a biosynthetic dressing developed by PolyMedics Innovations in Germany. Potential advantages to the use of Suprathel include its water solubility, elongation capacity, and porosity, which prevents fluid accumulation at the burn site. In a prior study, Suprathel was associated with favorable burn scar formation (improved Vancouver Scar Scale Scores) and decreased pain with dressing changes. In another study, adolescent and adult burn patients dressed in Suprathel reported significantly less pain than those who were dressed in Mepilex dressings. In post-treatment surveys, patients preferred the use of Suprathel when compared to Mepitel. In a study that compared Suprathel to other standard burn dressings, there was no statistical difference in wound healing, scar formation, and epithelization. Given the limitations in sample size and scarce pediatric data in prior studies, further research is necessary to determine the efficacy of Suprathel in the pediatric population and whether this is a dressing material that should be offered to hospital patients. New outpatients and inpatients who meet study inclusion criteria and require split-thickness skin grafting, will be randomized into the Suprathel group or the control group on the day of surgery. The investigators will use even calendar operative days for Suprathel and odd calendar operative days for Xeroform. Parental consent and/or patient assent will be obtained prior to the operative procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children 31 days old -17 years old
- •Have a burn injury or open wound of any percentage TBSA
- •Require a skin graft
Exclusion Criteria
- •allergy to one of the dressings involved in the study,
- •burn in close proximity to the donor site,
- •the donor site has been harvested in a previous surgery,
- •prisoners,
- •children under the protection of the department of human services,
- •pregnant women,
- •those with impaired decision-making capacity.
Outcomes
Primary Outcomes
Pain Before Dressing Change as assessed by r-FLACC
Time Frame: Weekly change in pain for 12 weeks
Burn clinic providers will rate each child's pain before and after dressing changes using the r-FLACC scoring tool. Scores range from 0-2, with higher scores indicating more pain.
POSAS Scale Score
Time Frame: Weekly change in scar from 3rd week to 12 weeks
This scale is a validated tool that will be adapted so that parents and providers score the child's wound based on several criteria. The observer/provider will evaluate vascularization, pigmentation, thickness, surface roughness, pliability, and surface area. The patient's parents will score six items: pain, pruritus, color, thickness, relief, and pliability. It is widely used in the burn literature to evaluate and report on the appearance of healed burn scars. Moreover, it routinely used in the burn clinic at CHCO to assess and serially document changes in the appearance of burn scars over time.
Change in Pain as Assessed using Visual Analog Scale
Time Frame: Weekly change in pain for 12 weeks
The visual analog scale is widely used to assess pain in the burn population. It was developed by Huskisson in 1974 and evaluates pain on a scale of 0 to 10; it has been validated in children \>7 years old.
PROMIS Pain Interference Survey
Time Frame: Weekly change in pain interference for 12 weeks
The PROMIS pain interference survey (short form) is an eight-question survey developed by the NIH to assess pain control over the past week in children \>8 years old.
PROMIS Pain Interference Proxy Survey
Time Frame: Weekly change in pain interference for 12 weeks
The PROMIS pain interference proxy form (short form) is an eight-question survey developed by the NIH to assess parents' perceptions of their child's pain control over the past week.
Pain Diary application (PainScale)
Time Frame: Day 1 through Day 7-10 Post-op
This is a free, downloadable application for androids and iPhones. It will be used by patients and/or their parents to document their pain severity, location, and medication use. Each report will be sent to the study coordinator via a HIPAA compliant server. Parents or patients will be asked to document their pain levels and pain medication use postoperatively for the first 7-10 days (until their first clinic appointment).
Change in Pain as Assessed by Bieri Faces Scale
Time Frame: Weekly change in pain for 12 weeks
The Bieri faces scale was developed in 1990 for children to self-report their pain levels by selecting a face corresponding to their pain severity. The Bieri faces scale has been validated in children \>5 years old. Children are asked to select one of 7 faces ranging from no pain to worst possible pain.
Pain After Dressing Change as assessed by r-FLACC
Time Frame: Weekly change in pain for 12 weeks
Burn clinic providers will rate each child's pain before and after dressing changes using the r-FLACC scoring tool. Scores range from 0-2, with higher scores indicating more pain.
Secondary Outcomes
- Cost of dressings(12 weeks)
- re-epithelialization(12 weeks)
- Burn Itch Severity as assessed by Itch Man Scale(12 weeks)
- Heal time(12 weeks)
- Infection(1 day (study visit) per week up to 12 weeks)