Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04014400
Recruitment Status : Terminated (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.)
First Posted : July 10, 2019
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Children's Hospital Colorado
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Burns Skin Graft Complications Skin; Deformity Other: Suprathel or Xeroform donor site application Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Suprathel Versus Xeroform for the Management of Pediatric and Adult Split Thickness Skin Graft Donor Sites
Actual Study Start Date : July 7, 2019
Actual Primary Completion Date : July 23, 2020
Actual Study Completion Date : July 23, 2020

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).


Secondary Outcome Measures :
  1. 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.

  2. Cost of dressings [ Time Frame: 12 weeks ]
    Overall dressing cost

  3. Heal time [ Time Frame: 12 weeks ]
    number of clinic visits until the burn provider or plastics PA considers the donor site(s) healed

  4. re-epithelialization [ Time Frame: 12 weeks ]
    Number of days to re-epithelialization

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   31 Days to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014400


Locations
Layout table for location information
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Children's Hospital Colorado
Investigators
Layout table for investigator information
Principal Investigator: Steven Moulton, MD Children's Hospital Colorado
Publications:

Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04014400    
Other Study ID Numbers: 19-1048
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
skin graft
suprathel
xeroform
burn
donor site
Additional relevant MeSH terms:
Layout table for MeSH terms
Skin Abnormalities
Congenital Abnormalities
Skin Diseases