BurnsSuprathelNCT04014400
Suprathel Versus Xeroform for the Management of Skin Graft Donor Sites
A study testing Suprathel or Xeroform donor site application in people with Burns and Skin Graft Complications, run by University of Colorado, Denver at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 31 days to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Burns, Skin Graft Complications, Skin; Deformity
- What is being tested?
- Suprathel or Xeroform donor site application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jul 2019to 23 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 days to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children 31 days old -17 years old
- Have a burn injury or open wound of any percentage TBSA
- Require a skin graft
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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.
- Conditions
- Burns, Skin Graft Complications, Skin; Deformity
- Being tested
- Suprathel or Xeroform donor site application
- Keywords
- skin graft, suprathel, xeroform, burn, donor site
- Medical subject headings
- Burns, Skin Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprathel or Xeroform donor site applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Suprathel or Xeroform donor site application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Day 1 through Day 7-10 Post-op
Secondary outcomes (5)
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.
Measured: 1 day (study visit) per week up to 12 weeks
Cost of dressings
Overall dressing cost
Measured: 12 weeks
Heal time
number of clinic visits until the burn provider or plastics PA considers the donor site(s) healed
Measured: 12 weeks
re-epithelialization
Number of days to re-epithelialization
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start7 Jul 2019
- Primary completion23 Jul 2020
- Study completion23 Jul 2020
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Steven Moulton, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014400
- Sponsor's protocol ID
- 19-1048
- Acronym
- Suprathel
- Status last verified
- Oct 2020
- First submitted
- 1 Jul 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reed JL, Pomerantz WJ. Emergency management of pediatric burns. Pediatr Emerg Care. 2005 Feb;21(2):118-29. doi: 10.1097/01.pec.0000159058.95424.0d. No abstract available.
PubMed 15699824Hundeshagen G, Collins VN, Wurzer P, Sherman W, Voigt CD, Cambiaso-Daniel J, Nunez Lopez O, Sheaffer J, Herndon DN, Finnerty CC, Branski LK. A Prospective, Randomized, Controlled Trial Comparing the Outpatient Treatment of Pediatric and Adult Partial-Thickness Burns with Suprathel or Mepilex Ag. J Burn Care Res. 2018 Feb 20;39(2):261-267. doi: 10.1097/BCR.0000000000000584.
PubMed 28557869Rashaan ZM, Krijnen P, Allema JH, Vloemans AF, Schipper IB, Breederveld RS. Usability and effectiveness of Suprathel(R) in partial thickness burns in children. Eur J Trauma Emerg Surg. 2017 Aug;43(4):549-556. doi: 10.1007/s00068-016-0708-z. Epub 2016 Jul 18.
PubMed 27432172Kaartinen IS, Kuokkanen HO. Suprathel((R)) causes less bleeding and scarring than Mepilex((R)) Transfer in the treatment of donor sites of split-thickness skin grafts. J Plast Surg Hand Surg. 2011 Sep;45(4-5):200-3. doi: 10.3109/2000656X.2011.583515.
PubMed 22150140Everett M, Massand S, Davis W, Burkey B, Glat PM. Use of a copolymer dressing on superficial and partial-thickness burns in a paediatric population. J Wound Care. 2015 Jul;24(7):S4-8. doi: 10.12968/jowc.2015.24.Sup7.S4.
PubMed 26198721Hansbrough W, Dore C, Hansbrough JF. Management of skin-grafted burn wounds with Xeroform and layers of dry coarse-mesh gauze dressing results in excellent graft take and minimal nursing time. J Burn Care Rehabil. 1995 Sep-Oct;16(5):531-4. doi: 10.1097/00004630-199509000-00012.
PubMed 8537426Gee Kee E, Kimble RM, Cuttle L, Stockton K. Comparison of three different dressings for partial thickness burns in children: study protocol for a randomised controlled trial. Trials. 2013 Nov 25;14:403. doi: 10.1186/1745-6215-14-403.
PubMed 24274190Piatkowski A, Drummer N, Andriessen A, Ulrich D, Pallua N. Randomized controlled single center study comparing a polyhexanide containing bio-cellulose dressing with silver sulfadiazine cream in partial-thickness dermal burns. Burns. 2011 Aug;37(5):800-4. doi: 10.1016/j.burns.2011.01.027. Epub 2011 Feb 23.
PubMed 21349646Vloemans AF, Hermans MH, van der Wal MB, Liebregts J, Middelkoop E. Optimal treatment of partial thickness burns in children: a systematic review. Burns. 2014 Mar;40(2):177-90. doi: 10.1016/j.burns.2013.09.016. Epub 2013 Nov 26.
PubMed 24290852Markl P, Prantl L, Schreml S, Babilas P, Landthaler M, Schwarze H. Management of split-thickness donor sites with synthetic wound dressings: results of a comparative clinical study. Ann Plast Surg. 2010 Nov;65(5):490-6. doi: 10.1097/SAP.0b013e3181d37624.
PubMed 20841998Cunningham NR, Kashikar-Zuck S, Mara C, Goldschneider KR, Revicki DA, Dampier C, Sherry DD, Crosby L, Carle A, Cook KF, Morgan EM. Development and validation of the self-reported PROMIS pediatric pain behavior item bank and short form scale. Pain. 2017 Jul;158(7):1323-1331. doi: 10.1097/j.pain.0000000000000914.
PubMed 28394851Liu Y, Yuan C, Wang J, Brown JG, Zhou F, Zhao X, Shen M, Hinds PS. Comparability of the Patient-Reported Outcomes Measurement Information System Pediatric short form symptom measures across culture: examination between Chinese and American children with cancer. Qual Life Res. 2016 Oct;25(10):2523-2533. doi: 10.1007/s11136-016-1312-8. Epub 2016 May 10.
PubMed 27165148Brandon TG, Becker BD, Bevans KB, Weiss PF. Patient-Reported Outcomes Measurement Information System Tools for Collecting Patient-Reported Outcomes in Children With Juvenile Arthritis. Arthritis Care Res (Hoboken). 2017 Mar;69(3):393-402. doi: 10.1002/acr.22937.
PubMed 27159889Bieri D, Reeve RA, Champion DG, Addicoat L, Ziegler JB. The Faces Pain Scale for the self-assessment of the severity of pain experienced by children: development, initial validation, and preliminary investigation for ratio scale properties. Pain. 1990 May;41(2):139-150. doi: 10.1016/0304-3959(90)90018-9.
PubMed 2367140Baxt C, Kassam-Adams N, Nance ML, Vivarelli-O'neill C, Winston FK. Assessment of pain after injury in the pediatric patient: child and parent perceptions. J Pediatr Surg. 2004 Jun;39(6):979-83; discussion 979-83. doi: 10.1016/j.jpedsurg.2004.02.031.
PubMed 15185239
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Suprathel Versus Xeroform for the Management of Pediatric and Adult Split Thickness Skin Graft Donor Sites
- ClinicalTrials.gov ID
- NCT04014400
- Acronym / sponsor ID
- Suprathel / 19-1048
- Conditions
- Burns, Skin Graft Complications, Skin; Deformity
- Keywords
- skin graft, suprathel, xeroform, burn, donor site
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- 7 Jul 2019 (actual)
- Primary completion
- 23 Jul 2020 (actual)
- Study completion
- 23 Jul 2020 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suprathel | Experimental | Other: Suprathel or Xeroform donor site applicationOnce 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. |
| Xeroform | Active comparator | Other: Suprathel or Xeroform donor site applicationAfter 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. |
Who may qualify
- Ages
- 31 days to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Children 31 days old -17 years old
- Have a burn injury or open wound of any percentage TBSA
- Require a skin graft
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suprathel or Xeroform donor site applicationThe 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. | Other | Suprathel, Xeroform |
Primary outcome
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 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.
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.
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).
5 secondary outcomes
Infection
Time frame: 1 day (study visit) per week up to 12 weeks
Cost of dressings
Time frame: 12 weeks
Heal time
Time frame: 12 weeks
re-epithelialization
Time frame: 12 weeks
Burn Itch Severity as assessed by Itch Man Scale
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Background: PubMed 15699824Reed JL, Pomerantz WJ. Emergency management of pediatric burns. Pediatr Emerg Care. 2005 Feb;21(2):118-29. doi: 10.1097/01.pec.0000159058.95424.0d. No abstract available.
- Background: PubMed 28557869Hundeshagen G, Collins VN, Wurzer P, Sherman W, Voigt CD, Cambiaso-Daniel J, Nunez Lopez O, Sheaffer J, Herndon DN, Finnerty CC, Branski LK. A Prospective, Randomized, Controlled Trial Comparing the Outpatient Treatment of Pediatric and Adult Partial-Thickness Burns with Suprathel or Mepilex Ag. J Burn Care Res. 2018 Feb 20;39(2):261-267. doi: 10.1097/BCR.0000000000000584.
- Background: PubMed 27432172Rashaan ZM, Krijnen P, Allema JH, Vloemans AF, Schipper IB, Breederveld RS. Usability and effectiveness of Suprathel(R) in partial thickness burns in children. Eur J Trauma Emerg Surg. 2017 Aug;43(4):549-556. doi: 10.1007/s00068-016-0708-z. Epub 2016 Jul 18.
- Background: PubMed 22150140Kaartinen IS, Kuokkanen HO. Suprathel((R)) causes less bleeding and scarring than Mepilex((R)) Transfer in the treatment of donor sites of split-thickness skin grafts. J Plast Surg Hand Surg. 2011 Sep;45(4-5):200-3. doi: 10.3109/2000656X.2011.583515.
- Background: PubMed 26198721Everett M, Massand S, Davis W, Burkey B, Glat PM. Use of a copolymer dressing on superficial and partial-thickness burns in a paediatric population. J Wound Care. 2015 Jul;24(7):S4-8. doi: 10.12968/jowc.2015.24.Sup7.S4.
- Background: PubMed 8537426Hansbrough W, Dore C, Hansbrough JF. Management of skin-grafted burn wounds with Xeroform and layers of dry coarse-mesh gauze dressing results in excellent graft take and minimal nursing time. J Burn Care Rehabil. 1995 Sep-Oct;16(5):531-4. doi: 10.1097/00004630-199509000-00012.
- Background: PubMed 24274190Gee Kee E, Kimble RM, Cuttle L, Stockton K. Comparison of three different dressings for partial thickness burns in children: study protocol for a randomised controlled trial. Trials. 2013 Nov 25;14:403. doi: 10.1186/1745-6215-14-403.
- Background: PubMed 21349646Piatkowski A, Drummer N, Andriessen A, Ulrich D, Pallua N. Randomized controlled single center study comparing a polyhexanide containing bio-cellulose dressing with silver sulfadiazine cream in partial-thickness dermal burns. Burns. 2011 Aug;37(5):800-4. doi: 10.1016/j.burns.2011.01.027. Epub 2011 Feb 23.
- Background: PubMed 24290852Vloemans AF, Hermans MH, van der Wal MB, Liebregts J, Middelkoop E. Optimal treatment of partial thickness burns in children: a systematic review. Burns. 2014 Mar;40(2):177-90. doi: 10.1016/j.burns.2013.09.016. Epub 2013 Nov 26.
- Background: PubMed 20841998Markl P, Prantl L, Schreml S, Babilas P, Landthaler M, Schwarze H. Management of split-thickness donor sites with synthetic wound dressings: results of a comparative clinical study. Ann Plast Surg. 2010 Nov;65(5):490-6. doi: 10.1097/SAP.0b013e3181d37624.
- Background: PubMed 28394851Cunningham NR, Kashikar-Zuck S, Mara C, Goldschneider KR, Revicki DA, Dampier C, Sherry DD, Crosby L, Carle A, Cook KF, Morgan EM. Development and validation of the self-reported PROMIS pediatric pain behavior item bank and short form scale. Pain. 2017 Jul;158(7):1323-1331. doi: 10.1097/j.pain.0000000000000914.
- Background: PubMed 27165148Liu Y, Yuan C, Wang J, Brown JG, Zhou F, Zhao X, Shen M, Hinds PS. Comparability of the Patient-Reported Outcomes Measurement Information System Pediatric short form symptom measures across culture: examination between Chinese and American children with cancer. Qual Life Res. 2016 Oct;25(10):2523-2533. doi: 10.1007/s11136-016-1312-8. Epub 2016 May 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Moulton, MD principal investigator
Children's Hospital Colorado
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprathel or Xeroform donor site application in people with Burns and Skin Graft Complications, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain as Assessed by Bieri Faces Scale (time frame: Weekly change in pain for 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04014400, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.