Suprathel Versus Xeroform for the Management of Skin Graft Donor Sites

NCT04014400 | Terminated DMC

• 1 other identifier: 19-1048
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Burns; Skin Graft Complications; Skin; Deformity

Keywords

skin graft; suprathel; xeroform; burn; donor site

Outcome Measures

Primary Outcomes (8)

• 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.

  Weekly change in pain for 12 weeks

• 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.

  Weekly change in pain for 12 weeks

• 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.

  Weekly change in pain for 12 weeks

• 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.

  Weekly change in scar from 3rd week to 12 weeks

• 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.

  Weekly change in pain for 12 weeks

• 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.

  Weekly change in pain interference for 12 weeks

• 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.

  Weekly change in pain interference for 12 weeks

• 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).

  Day 1 through Day 7-10 Post-op

Secondary Outcomes (5)

• Infection

  1 day (study visit) per week up to 12 weeks

• Cost of dressings

  12 weeks

• Heal time

  12 weeks

• re-epithelialization

  12 weeks

• Burn Itch Severity as assessed by Itch Man Scale

  12 weeks

Study Arms (2)

Suprathel

EXPERIMENTAL

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

Xeroform

ACTIVE COMPARATOR

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

Interventions

Suprathel or Xeroform donor site application OTHER

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.

Suprathel; Xeroform

Eligibility Criteria

• Age: 31 Days - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Children 31 days old -17 years old
• Have a burn injury or open wound of any percentage TBSA
• Require a skin graft

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Children's Hospital Colorado: collaborator

Study Sites (2)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (24)

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MeSH Terms

Conditions

Burns; Skin Abnormalities

Interventions

poly(lactide-co-trimethylenecarbonate-co-epsilon-caprolactone)

Condition Hierarchy (Ancestors)

Wounds and Injuries; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Steven Moulton, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 10, 2019
• Study Start: July 7, 2019
• Primary Completion: July 23, 2020
• Study Completion: July 23, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)