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

Primary Purpose

Burns, Skin Graft Complications, Skin; Deformity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Suprathel or Xeroform donor site application
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring skin graft, suprathel, xeroform, burn, donor site

Eligibility Criteria

31 Days - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Children's Hospital Colorado
  • University of Colorado Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Suprathel

Xeroform

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Pain as Assessed by Bieri Faces Scale
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 Before Dressing Change as assessed by r-FLACC
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.
Pain After Dressing Change as assessed by r-FLACC
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
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
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
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
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)
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).

Secondary Outcome Measures

Infection
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.
Cost of dressings
Overall dressing cost
Heal time
number of clinic visits until the burn provider or plastics PA considers the donor site(s) healed
re-epithelialization
Number of days to re-epithelialization
Burn Itch Severity as assessed by Itch Man Scale
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.

Full Information

First Posted
July 1, 2019
Last Updated
October 20, 2020
Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado
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1. Study Identification

Unique Protocol Identification Number
NCT04014400
Brief Title
Suprathel Versus Xeroform for the Management of Skin Graft Donor Sites
Acronym
Suprathel
Official Title
A Randomized Controlled Trial Comparing Suprathel Versus Xeroform for the Management of Pediatric and Adult Split Thickness Skin Graft Donor Sites
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
We observed that using the Suprathel dressing required additional treatment of the wound and had a longer healing time than the standard of care Xeroform dressing; it did not dry the wound out properly to promote healing.
Study Start Date
July 7, 2019 (Actual)
Primary Completion Date
July 23, 2020 (Actual)
Study Completion Date
July 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Children's Hospital Colorado

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Skin Graft Complications, Skin; Deformity
Keywords
skin graft, suprathel, xeroform, burn, donor site

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suprathel
Arm Type
Experimental
Arm Description
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.
Arm Title
Xeroform
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Suprathel or Xeroform donor site application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain as Assessed by Bieri Faces Scale
Description
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.
Time Frame
Weekly change in pain for 12 weeks
Title
Pain Before Dressing Change as assessed by r-FLACC
Description
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.
Time Frame
Weekly change in pain for 12 weeks
Title
Pain After Dressing Change as assessed by r-FLACC
Description
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.
Time Frame
Weekly change in pain for 12 weeks
Title
POSAS Scale Score
Description
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.
Time Frame
Weekly change in scar from 3rd week to 12 weeks
Title
Change in Pain as Assessed using Visual Analog Scale
Description
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.
Time Frame
Weekly change in pain for 12 weeks
Title
PROMIS Pain Interference Survey
Description
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.
Time Frame
Weekly change in pain interference for 12 weeks
Title
PROMIS Pain Interference Proxy Survey
Description
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.
Time Frame
Weekly change in pain interference for 12 weeks
Title
Pain Diary application (PainScale)
Description
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).
Time Frame
Day 1 through Day 7-10 Post-op
Secondary Outcome Measure Information:
Title
Infection
Description
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.
Time Frame
1 day (study visit) per week up to 12 weeks
Title
Cost of dressings
Description
Overall dressing cost
Time Frame
12 weeks
Title
Heal time
Description
number of clinic visits until the burn provider or plastics PA considers the donor site(s) healed
Time Frame
12 weeks
Title
re-epithelialization
Description
Number of days to re-epithelialization
Time Frame
12 weeks
Title
Burn Itch Severity as assessed by Itch Man Scale
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
31 Days
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Moulton, MD
Organizational Affiliation
Children's Hospital Colorado
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Suprathel Versus Xeroform for the Management of Skin Graft Donor Sites

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