Second-degree BurnNCT04149808
Mepilex Ag vs. Xeroform in Pediatric Patients That Sustain Partial Thickness Burn Injury
A study testing Mepilex Ag (burn dressing) and Xeroform Dressing in people with Second-degree Burn, run by Wayne State University at 1 site in United States.
Trial summary
Pediatric patients that sustain partial thickness burn injuries to their extremities require regular scheduled dressings and weekly appointments for better healing. Typically, the dressing used at Children's Hospital of Michigan is Xeroform, which can often be painful when changing at the weekly clinic appointment. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Second-degree Burn
- What is being tested?
- Mepilex Ag (burn dressing) and Xeroform Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 1 Sep 2022
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients under age 17 presenting to Children's Hospital of Michigan burn center or burn clinic with partial thickness, second degree scald burns to extremities.
- Burn of 1% TBSA or greater
- Within 48 hours of injury.
- Signed consent form (and oral assent for patients ages 7-12 or written assent for patients 13 years of age or greater).
Who cannot join
- Flame burns
- age over 18 years
- infection
- skin graft or donor site
- burns greater than 48 hours old.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Michigan
Detroit, Michigan, 48201
About this study
Official title: Comparative Prospective Study of Mepilex Ag vs. Xeroform in Pediatric Patients That Sustain Partial Thickness Burn Injury
Pediatric patients that sustain partial thickness burn injuries to their extremities require regular scheduled dressings and weekly appointments for better healing. Typically, the dressing used at Children's Hospital of Michigan is Xeroform, which can often be painful when changing at the weekly clinic appointment. Mepilex Ag is also an approved treatment for these types of burns and has the potential to cause less pain with dressing changes, however is not used as frequently due to a much higher cost. Studies evaluating the treatment of partial thickness burns in pediatric patients have shown decreased cost and length of stay associated with dressings that are silver impregnated, like Mepilex Ag. However, these studies are all retrospective with a possible selection bias to patients. In addition, several studies have suggested less pain with newer foam and hydrofiber dressings. We are conducting a prospective study using patients with partial thickness burns of their extremities, applying Xeroform on half of the burn, and Mepilex Ag on the other half of the burn, to remove confounding variables between patients to determine the optimal burn dressing for partial thickness scald burns for pediatric patients. A partial thickness burn, also known as a second degree burn, extends into the top two layers of the skin, not passing the hypodermis. Our goal is to determine if Xeroform or Mepilex Ag is superior treatment for partial thickness burns in pediatric patients for healing time, appearance of scar, and patient pain and comfort during treatment and dressing changes.
Read the detailed description
The patients will be recruited at the Children's Hospital of Michigan burn center or clinic by research personnel. If a patient is determined to fit inclusion criteria, parental consent will be obtained using the attached consent form by one of the research personnel. If the parent speaks another language, written consent will be obtained after explanation of the study and a short consent form in the native language. Also, a translator will be used to explain the full consent form used for English speaking patients. This form will be witnessed by a person who speaks the native language fluently. Only one parent will be required to sign consent as many patients only have one parent available in the hospital with them and this study involves only treatments that are current standard of care. If the patient is ages 7-12 years, an oral assent will be completed before participation in the study. If the patient is between ages 13-17, an assent form will be explained to them and their signature required to participate in the study. If they speak another language, assent will be obtained using a translator and the same methods listed above for parental consent. If the recruitment accrues beyond 4-6 non-english speaking participants, who speak a certain language, the consent forms will be translated into this language for future participants.
Study Protocol:
Once consent is obtained, and the patient is determined to be ready for a dressing application, one half of the extremity burn will be treated with Mepilex Ag and the other half of the extremity burn will be treated with Xeroform. Both of these treatments are current standard of care for a partial thickness scald burn in pediatric patients. The patients will be followed inpatient until they are discharged and then followed weekly at burn clinic appointments, the same care all of our burn patients receive. A survey will be administered to burn staff and patient's parents when the treatments are applied, at follow-up clinic appointments, and after the wound is healed completely. We will evaluate clinician and nurse ease of use, comfort of each dressing for the child, pain and itching associated with each dressing and dressing change, healing time, appearance of the scar after it is completely healed using the Vancouver Scar Scale, and parental satisfaction and ease of use for each dressing.
Data Collection and Evaluation:
A chart review will be performed for all patients to obtain demographic data including age, name, birth date, date of injury, injury details, the initial treatment applied if a different dressing was used before the patient was ready for application of Xeroform or Mepilex Ag, and any other pertinent information regarding the burn treatment. Study personnel and an attending physician will evaluate each patient at weekly follow-up visits or inpatient if the patient is being treated in the hospital. Survey results and other data will be evaluated after 10 patients complete treatment. Photographs taken as part of every burn patient's care may be reviewed as part of the study. These are obtained by medical photography and securely stored digitally. The Vancouver Scar Scale will be used for final evaluation of the healed scar after treatment is complete.
All data obtained in paper form will be stored in a locked filing cabinet in a locked office in the Pediatric Surgery Department and data obtained in digital form will be secure in a password protected file on the electronic medical record server.
Statistics will be performed using Statistical Package for Social Sciences (IBM version 22.0) and the statistical program R (r-project.org). The statistics to be performed for continuous variables (which are most of the assessment measures) will include a dependent groups analysis (e.g. paired samples t-test or robust analogue of this test such as Yuen's method for trimmed means, comparing medians, or bootstrap methods). The statistics to be performed for dichotomous measures will be the Sign test, which assesses differences in positive and negative outcomes for each treatment group.
- Conditions
- Second-degree Burn
- Being tested
- Mepilex Ag (burn dressing), Xeroform Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepilex Ag (burn dressing)Device
Dressing for low to medium exuding burns and wounds.
Xeroform DressingDevice
Standard of care dressing for low to medium exuding burns and wounds.
| Study group | Role | What they receive |
|---|---|---|
| Xeroform Control | Active comparator | A single wound is treated with both the control (xeroform dressing) and intervention (Mepilex Ag). Approximately 50% of the wound is treated with xeroform dressing, which is the standard of care. Receives: Device: Xeroform Dressing |
| Mepilex Ag Intervention | Experimental | A single wound is treated with both the control (xeroform dressing) and intervention (Mepilex Ag). Approximately 50% of the wound is treated with Mepilex Ag; the product being tested. Receives: Device: Mepilex Ag (burn dressing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar Evaluation
Vancouver Scar Scale: 0 is defined as normal in all instances
- Vascularity: 0 to 3
- Pigmentation: 0 to 3
- Pliability/Elasticity: 0 to 5
- Height: 0 to 3
- Pain: 0 to 2
- Itchiness: 0 to 2
Measured: burn injury healing time; up to 10 weeks
Secondary outcomes (1)
Dressing Change Survey
- Ease of application: 1 to 3; 3 is easiest
- Pain during application: 1 to 10; 10 is most painful
Measured: during the burn injury treatment, up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Why it stopped: The study was never conducted and no parcipants were ever enrolled and study never initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Second-degree BurnStudies of the same condition, open and under way.
- 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
- Model description
- Patients under age 18 presenting to Children's Hospital of Michigan burn center or burn clinic with partial thickness, second degree scald burns.The burn must be at least 1% total body surface area (TBSA) or greater. The burn is divided approximately in half, with 50% of the wound receiving xeroform dressing and the remaining 50% receiving Mepilex Ag. Patients must present within 48 hours of injury. Patients must have a signed consent form (and oral assent for patients ages 7-12 or written assent for patients 13 years of age or greater).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elika Ridelman, Wayne State University
- Investigators
- Elika Ridelman, PhD, Study director, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149808
- Sponsor's protocol ID
- 061019MP2E
- Status last verified
- Oct 2019
- First submitted
- 25 Jun 2019
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bugmann P, Taylor S, Gyger D, Lironi A, Genin B, Vunda A, La Scala G, Birraux J, Le Coultre C. A silicone-coated nylon dressing reduces healing time in burned paediatric patients in comparison with standard sulfadiazine treatment: a prospective randomized trial. Burns. 1998 Nov;24(7):609-12. doi: 10.1016/s0305-4179(98)00095-3.
PubMed 9882058Dykes PJ, Heggie R. The link between the peel force of adhesive dressings and subjective discomfort in volunteer subjects. J Wound Care. 2003 Jul;12(7):260-2. doi: 10.12968/jowc.2003.12.7.26567.
PubMed 12894697Gotschall CS, Morrison MI, Eichelberger MR. Prospective, randomized study of the efficacy of Mepitel on children with partial-thickness scalds. J Burn Care Rehabil. 1998 Jul-Aug;19(4):279-83. doi: 10.1097/00004630-199807000-00002.
PubMed 9710723Hollinworth H, Collier M. Nurses' views about pain and trauma at dressing changes: results of a national survey. J Wound Care. 2000 Sep;9(8):369-73. doi: 10.12968/jowc.2000.9.8.26282.
PubMed 11933365O'Donovan DA, Mehdi SY, Eadie PA. The role of Mepitel silicone net dressings in the management of fingertip injuries in children. J Hand Surg Br. 1999 Dec;24(6):727-30. doi: 10.1054/jhsb.1999.0270.
PubMed 10672813Platt AJ, Phipps A, Judkins K. A comparative study of silicone net dressing and paraffin gauze dressing in skin-grafted sites. Burns. 1996 Nov;22(7):543-5. doi: 10.1016/0305-4179(96)00035-6.
PubMed 8909755Williams G, Withey S, Walker CC. Longstanding pigmentary changes in paediatric scalds dressed with a non-adherent siliconised dressing. Burns. 2001 Mar;27(2):200-2. doi: 10.1016/s0305-4179(00)00082-6.
PubMed 11226664Winter GD (1975) Methods for the biological evaluation of dressings. In: Turner TD, Brain KR, eds. Surgical Dressings in the Hospital Environment. Surgical Dressings Research Unit, UWIST, Cardiff: 47-81
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Prospective Study of Mepilex Ag vs. Xeroform in Pediatric Patients That Sustain Partial Thickness Burn Injury
- ClinicalTrials.gov ID
- NCT04149808
- Acronym / sponsor ID
- 061019MP2E
- Conditions
- Second-degree Burn
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never conducted and no parcipants were ever enrolled and study never initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 4 Nov 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.
Pediatric patients that sustain partial thickness burn injuries to their extremities require regular scheduled dressings and weekly appointments for better healing. Typically, the dressing used at Children's Hospital of Michigan is Xeroform, which can often be painful when changing at the weekly clinic appointment. Mepilex Ag is also an approved treatment for these types of burns and has the potential to cause less pain with dressing changes, however is not used as frequently due to a much higher cost. Studies evaluating the treatment of partial thickness burns in pediatric patients have shown decreased cost and length of stay associated with dressings that are silver impregnated, like Mepilex Ag. However, these studies are all retrospective with a possible selection bias to patients. In addition, several studies have suggested less pain with newer foam and hydrofiber dressings. We are conducting a prospective study using patients with partial thickness burns of their extremities, applying Xeroform on half of the burn, and Mepilex Ag on the other half of the burn, to remove confounding variables between patients to determine the optimal burn dressing for partial thickness scald burns for pediatric patients. A partial thickness burn, also known as a second degree burn, extends into the top two layers of the skin, not passing the hypodermis. Our goal is to determine if Xeroform or Mepilex Ag is superior treatment for partial thickness burns in pediatric patients for healing time, appearance of scar, and patient pain and comfort during treatment and dressing changes.
Detailed description
The patients will be recruited at the Children's Hospital of Michigan burn center or clinic by research personnel. If a patient is determined to fit inclusion criteria, parental consent will be obtained using the attached consent form by one of the research personnel. If the parent speaks another language, written consent will be obtained after explanation of the study and a short consent form in the native language. Also, a translator will be used to explain the full consent form used for English speaking patients. This form will be witnessed by a person who speaks the native language fluently. Only one parent will be required to sign consent as many patients only have one parent available in the hospital with them and this study involves only treatments that are current standard of care. If the patient is ages 7-12 years, an oral assent will be completed before participation in the study. If the patient is between ages 13-17, an assent form will be explained to them and their signature required to participate in the study. If they speak another language, assent will be obtained using a translator and the same methods listed above for parental consent. If the recruitment accrues beyond 4-6 non-english speaking participants, who speak a certain language, the consent forms will be translated into this language for future participants.
Study Protocol:
Once consent is obtained, and the patient is determined to be ready for a dressing application, one half of the extremity burn will be treated with Mepilex Ag and the other half of the extremity burn will be treated with Xeroform. Both of these treatments are current standard of care for a partial thickness scald burn in pediatric patients. The patients will be followed inpatient until they are discharged and then followed weekly at burn clinic appointments, the same care all of our burn patients receive. A survey will be administered to burn staff and patient's parents when the treatments are applied, at follow-up clinic appointments, and after the wound is healed completely. We will evaluate clinician and nurse ease of use, comfort of each dressing for the child, pain and itching associated with each dressing and dressing change, healing time, appearance of the scar after it is completely healed using the Vancouver Scar Scale, and parental satisfaction and ease of use for each dressing.
Data Collection and Evaluation:
A chart review will be performed for all patients to obtain demographic data including age, name, birth date, date of injury, injury details, the initial treatment applied if a different dressing was used before the patient was ready for application of Xeroform or Mepilex Ag, and any other pertinent information regarding the burn treatment. Study personnel and an attending physician will evaluate each patient at weekly follow-up visits or inpatient if the patient is being treated in the hospital. Survey results and other data will be evaluated after 10 patients complete treatment. Photographs taken as part of every burn patient's care may be reviewed as part of the study. These are obtained by medical photography and securely stored digitally. The Vancouver Scar Scale will be used for final evaluation of the healed scar after treatment is complete.
All data obtained in paper form will be stored in a locked filing cabinet in a locked office in the Pediatric Surgery Department and data obtained in digital form will be secure in a password protected file on the electronic medical record server.
Statistics will be performed using Statistical Package for Social Sciences (IBM version 22.0) and the statistical program R (r-project.org). The statistics to be performed for continuous variables (which are most of the assessment measures) will include a dependent groups analysis (e.g. paired samples t-test or robust analogue of this test such as Yuen's method for trimmed means, comparing medians, or bootstrap methods). The statistics to be performed for dichotomous measures will be the Sign test, which assesses differences in positive and negative outcomes for each treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients under age 18 presenting to Children's Hospital of Michigan burn center or burn clinic with partial thickness, second degree scald burns.The burn must be at least 1% total body surface area (TBSA) or greater. The burn is divided approximately in half, with 50% of the wound receiving xeroform dressing and the remaining 50% receiving Mepilex Ag. Patients must present within 48 hours of injury. Patients must have a signed consent form (and oral assent for patients ages 7-12 or written assent for patients 13 years of age or greater).
| Arm | Type | Receives |
|---|---|---|
| Xeroform Control | Active comparator | Device: Xeroform DressingA single wound is treated with both the control (xeroform dressing) and intervention (Mepilex Ag). Approximately 50% of the wound is treated with xeroform dressing, which is the standard of care. |
| Mepilex Ag Intervention | Experimental | Device: Mepilex Ag (burn dressing)A single wound is treated with both the control (xeroform dressing) and intervention (Mepilex Ag). Approximately 50% of the wound is treated with Mepilex Ag; the product being tested. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients under age 17 presenting to Children's Hospital of Michigan burn center or burn clinic with partial thickness, second degree scald burns to extremities.
- Burn of 1% TBSA or greater
- Within 48 hours of injury.
- Signed consent form (and oral assent for patients ages 7-12 or written assent for patients 13 years of age or greater).
Key exclusion criteria (5 listed)
- Flame burns
- age over 18 years
- infection
- skin graft or donor site
- burns greater than 48 hours old.
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 |
|---|---|---|
| Mepilex Ag (burn dressing)Dressing for low to medium exuding burns and wounds. | Device | Mepilex Ag Intervention |
| Xeroform DressingStandard of care dressing for low to medium exuding burns and wounds. | Device | Xeroform Control |
Primary outcome
Scar Evaluation
Time frame: burn injury healing time; up to 10 weeks
Vancouver Scar Scale: 0 is defined as normal in all instances * Vascularity: 0 to 3 * Pigmentation: 0 to 3 * Pliability/Elasticity: 0 to 5 * Height: 0 to 3 * Pain: 0 to 2 * Itchiness: 0 to 2
1 secondary outcome
Dressing Change Survey
Time frame: during the burn injury treatment, up to 10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Background: PubMed 9882058Bugmann P, Taylor S, Gyger D, Lironi A, Genin B, Vunda A, La Scala G, Birraux J, Le Coultre C. A silicone-coated nylon dressing reduces healing time in burned paediatric patients in comparison with standard sulfadiazine treatment: a prospective randomized trial. Burns. 1998 Nov;24(7):609-12. doi: 10.1016/s0305-4179(98)00095-3.
- Background: PubMed 12894697Dykes PJ, Heggie R. The link between the peel force of adhesive dressings and subjective discomfort in volunteer subjects. J Wound Care. 2003 Jul;12(7):260-2. doi: 10.12968/jowc.2003.12.7.26567.
- Background: PubMed 9710723Gotschall CS, Morrison MI, Eichelberger MR. Prospective, randomized study of the efficacy of Mepitel on children with partial-thickness scalds. J Burn Care Rehabil. 1998 Jul-Aug;19(4):279-83. doi: 10.1097/00004630-199807000-00002.
- Background: PubMed 11933365Hollinworth H, Collier M. Nurses' views about pain and trauma at dressing changes: results of a national survey. J Wound Care. 2000 Sep;9(8):369-73. doi: 10.12968/jowc.2000.9.8.26282.
- Background: PubMed 10672813O'Donovan DA, Mehdi SY, Eadie PA. The role of Mepitel silicone net dressings in the management of fingertip injuries in children. J Hand Surg Br. 1999 Dec;24(6):727-30. doi: 10.1054/jhsb.1999.0270.
- Background: PubMed 8909755Platt AJ, Phipps A, Judkins K. A comparative study of silicone net dressing and paraffin gauze dressing in skin-grafted sites. Burns. 1996 Nov;22(7):543-5. doi: 10.1016/0305-4179(96)00035-6.
- Background: PubMed 11226664Williams G, Withey S, Walker CC. Longstanding pigmentary changes in paediatric scalds dressed with a non-adherent siliconised dressing. Burns. 2001 Mar;27(2):200-2. doi: 10.1016/s0305-4179(00)00082-6.
- BackgroundWinter GD (1975) Methods for the biological evaluation of dressings. In: Turner TD, Brain KR, eds. Surgical Dressings in the Hospital Environment. Surgical Dressings Research Unit, UWIST, Cardiff: 47-81
- Pain at wound dressing changeLink provided by the sponsor.
- Tool for assessing pain during dressing changesLink provided by the sponsor.
- Descriptions of non-adherent dressings, their classification, and benefitsLink provided by the sponsor.
- 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.
Elika Ridelman, PhD study director
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepilex Ag (burn dressing) and Xeroform Dressing in people with Second-degree Burn, run by Wayne State University at 1 site 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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 withdrawn before enrolling participants, so there are no results.
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?
Scar Evaluation (time frame: burn injury healing time; up to 10 weeks). 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 NCT04149808, which also lists 8 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 26 Jan 2023.