Suprathel Versus Xeroform for the Management of Skin Graft Donor Sites (Suprathel)

October 20, 2020 updated by: University of Colorado, Denver

A Randomized Controlled Trial Comparing Suprathel Versus Xeroform for the Management of Pediatric and Adult Split Thickness Skin Graft Donor Sites

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 78 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suprathel
Once hemostasis is obtained, the Suprathel material will be handled with a new pair of sterile gloves. It will be cut so that the material extends 1-2 cm beyond the donor site margins, then applied to the donor site. The Suprathel will be secured with a protective layer of Rylon extending 1-2 cms beyond the margins of the Suprathel. The primary dressing will be covered with cotton gauze (4x4 fluff gauze pads) and wrapped with rolled gauze). The outer dressing will be changed 7-10 days post-op. The Suprathel and Rylon will remain in place until they can be easily peeled off. To facilitate the pain-free and easy removal of the primary Suprathel dressing, practioners will apply Vaseline or lotion to saturate and loosen the material. The patients will be followed on average about once per week in an outpatient clinic until the Suprathel (and Rylon) are removed, but they may continue to be seen until the STSG is fully healed.
Other: Suprathel or Xeroform donor site application
The surgical procedure for recovery of a skin graft will be the same for all patients as follows. Once the patient is taken to the operating room, the selected donor site will be prepared and harvested with a Zimmer Dermatome set at 0.007 to 0.009 thousands of an inch for pediatric patients and 0.12 to 0.14 thousands for adult patients. After the harvesting procedure, the donor site will be covered with Telfa saturated with 1:10,000 epinephrine in normal saline until hemostasis is achieved. The Telfa will be irrigated off the donor site with the epinephrine saline solution. The surgeon will don a new pair of sterile gloves to handle the donor site dressing. The randomized dressing will be applied over the hemostatic donor site with an approximate 1-2cm border. Next, the wound will be dressed with 4x4 cotton gauze pads (fluffs), rolled gauze (Kerlix) and either Coban or BandNet.
Active Comparator: Xeroform
After hemostasis occurs, the Xeroform dressing will be handled with a new pair of sterile gloves and cut so that the material extends 1-2 cm beyond the donor site margins, then applied to the donor site. The primary dressing will be covered with cotton gauze (4x4 fluff gauze pads) and wrapped with rolled gauze (Kerlix). The outer dressing will be changed 7-10 days post-op. The Xeroform will remain in place until it can be easily peeled off. To facilitate the pain-free and easy removal of the Xeroform dressing, practioners may apply Vaseline or lotion to saturate and loosen the material. The patients will be followed on average about once per week in an outpatient clinic until the Xeroform is removed, but they may continue to be seen until the STSG is fully healed.
Other: Suprathel or Xeroform donor site application
The surgical procedure for recovery of a skin graft will be the same for all patients as follows. Once the patient is taken to the operating room, the selected donor site will be prepared and harvested with a Zimmer Dermatome set at 0.007 to 0.009 thousands of an inch for pediatric patients and 0.12 to 0.14 thousands for adult patients. After the harvesting procedure, the donor site will be covered with Telfa saturated with 1:10,000 epinephrine in normal saline until hemostasis is achieved. The Telfa will be irrigated off the donor site with the epinephrine saline solution. The surgeon will don a new pair of sterile gloves to handle the donor site dressing. The randomized dressing will be applied over the hemostatic donor site with an approximate 1-2cm border. Next, the wound will be dressed with 4x4 cotton gauze pads (fluffs), rolled gauze (Kerlix) and either Coban or BandNet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Weekly change in pain for 12 weeks
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.
Weekly change in pain for 12 weeks
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.
Weekly change in pain for 12 weeks
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.
Weekly change in scar from 3rd week to 12 weeks
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.
Weekly change in pain for 12 weeks
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.
Weekly change in pain interference for 12 weeks
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.
Weekly change in pain interference for 12 weeks
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).
Day 1 through Day 7-10 Post-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection
Time Frame: 1 day (study visit) per week up to 12 weeks
Presence of absence of infection at the donor site (s) based on odor, rash, deep red appearance or pruritus--these wounds will typically not be cultured.
1 day (study visit) per week up to 12 weeks
Cost of dressings
Time Frame: 12 weeks
Overall dressing cost
12 weeks
Heal time
Time Frame: 12 weeks
number of clinic visits until the burn provider or plastics PA considers the donor site(s) healed
12 weeks
re-epithelialization
Time Frame: 12 weeks
Number of days to re-epithelialization
12 weeks
Burn Itch Severity as assessed by Itch Man Scale
Time Frame: 12 weeks
The Itch man scale is validated in patients 6 years or older and uses a Likert scale to quantify the degree of itchiness. A score of 0 is not itchy at all, a score of 4 reflects the most itchy.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Children's Hospital Colorado

Investigators

  • Principal Investigator: Steven Moulton, MD, Children's Hospital Colorado

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2019

Primary Completion (Actual)

July 23, 2020

Study Completion (Actual)

July 23, 2020

Study Registration Dates

First Submitted

July 1, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (Actual)

July 10, 2019

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-1048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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