BurnNCT06786884
Paraffin Wax and Exercise Prospective
A study testing paraffin wax in people with Burn and Scar, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
This study is being done to test if paraffin wax can be used to improve the range of motion and function for scars across joints when used in combination with scar rehabilitation therapy sessions. For those randomized to receive it, the paraffin wax will be used alongside the participants' exercise therapy treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn, Scar, Exercise Therapy
- What is being tested?
- paraffin wax
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patients with burn scar that crosses an upper or lower extremity joint (shoulder, elbow, wrist, hand, hip, knee, ankle)
- Patients that have been prescribed a rehabilitation program where paraffin wax could be used as an adjunct to rehab exercise therapy
Who cannot join
- Adults unable to provide informed consent
- Injury etiology other than burn (ex: cutaneous trauma, cold injury, etc.)
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MedStar Washington Hosptial Center
Washington D.C., District of Columbia, 20010
Clinical Research Coordinator, 202-877-5170, FBSRLRESEARCH@medstar.net
Bonnie C Carney, PhD
About this study
Official title: A Pilot, Randomized Controlled Trial Evaluating the Effectiveness of Paraffin Wax On Burn Patient Function, Range of Motion and Scar
This study is being done to test if paraffin wax can be used to improve the range of motion and function for scars across joints when used in combination with scar rehabilitation therapy sessions. For those randomized to receive it, the paraffin wax will be used alongside the participants' exercise therapy treatments. Currently, treatments that are used in addition to rehabilitation therapy for increasing range of motion across joints in the burn population are limited. By getting more information about how paraffin wax may or may not work, patients in the future that have scars may be able to be helped.
Read the detailed description
If the participants agree to take part in this study, the participants scars will be looked at and the investigators will select one site that will be involved in the research. The scar will be "randomized" to the paraffin wax or no paraffin wax groups. The treatment the participants get will be chosen by chance, like flipping a coin. Neither the participants nor the study doctor will choose what treatment you get. The participants will have a 50% chance of being given either paraffin wax or not.
The study will take place in an outpatient setting. The participants will not be admitted to the hospital overnight. All patients who enter the study will be required to follow-up for regular appointments with their burn department.
Before the participants begin treatment, the participants will come in for a pre-treatment visit where the investigators will collection information about the participants scars such as pictures, range of motion measurements, non-invasive probes, non-invasive imaging (Laser doppler imaging) and questionnaires. These questionnaires will be related to the symptoms, range of motion, function, and appearance of the participants' burn scars. At the pre-treatment visit, there is an also an optional blood draw where less than 2 tablespoons of blood are collected. It is estimated this visit will take less than 1 hour. The investigators will also collect information from the medical record about prior surgical and medical history.
Exercise treatments (which the participants have previously chosen to undergo in talking with the participants doctor) will occur approximately in 1-2-week intervals depending on what the Burn Center scheduling department allows. For completion of this study, the participants will undergo 4 exercise therapy sessions which may take about 8 weeks.
At each visit, the following measurements will be captured before and after each exercise session. Those assigned to the paraffin wax group will have an additional assessment collected before their exercise therapy session and after the paraffin wax has been removed. Measurements at each visit include active and passive range of motion measurements of the affected joint, non-invasive probe measurements to measure water loss and hardness of your scar and the adjacent area of normal skin, digital photography, non-invasive laser doppler imaging (LDI), surface-level skin temperature measurements using either an infrared thermometer or skin temperature strip as well as pain and itch rating scales.
When applicable, the paraffin wax will be applied to the top of the scar for 15 minutes and repeat measurements previously listed above will be collected before your standard of care rehabilitation session. These sessions conducted by the burn rehab therapist may include scar massage, exercises, and functional activity. Specific treatments will be documented.
At each study visit, photographs will be taken of the study designated scar. All photographs taken for the purpose of this study will be taken by a high-resolution study camera. Photographs will be labeled with your study ID number. All efforts will be made to minimize the amount of identifiable information such as the participants' face or tattoos in these photos.
The procedures/treatments in this study that are considered experimental/investigation are: the use of the study product (paraffin wax) to assess the effect on burn scar that crosses an extremity joint during rehabilitation exercises.
The following procedures are part of the research study and would not normally be done as part of routine care: study provided paraffin wax and control application to the scar, scar assessments, digital photography, LDI, non-invasive imaging and measurements. These procedures are part of the study and will not be charged to insurance.
- Conditions
- Burn, Scar, Exercise Therapy
- Being tested
- paraffin wax, standard of care exercise therapy
- Keywords
- paraffin wax, burn scar, scar, burn, range of motion
- Medical subject headings
- Burns, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paraffin waxDevice
This is the treatment group that will receive exercise and paraffin wax
standard of care exercise therapyDevice
This is the group that will only receive exercise therapy and no paraffin wax.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Therapy Only | Other | Not described Receives: Device: standard of care exercise therapy |
| Exercise Therapy with Paraffin Wax Treatment | Experimental | Not described Receives: Device: paraffin wax; Device: standard of care exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Range of motion (degrees) of the affected joint before and after paraffin wax between the paraffin and no paraffin groups
Measured: 4th exercise session, an average of 4 weeks post enrollment
Secondary outcomes (9)
Trans-epidermal water loss
Trans-epidermal water loss (TEWL)(kg/m2h) of the HTS before and after paraffin wax between the paraffin and no paraffin groups.
Minimum: 0 Maximum: 100 Higher score is a worse outcome.
Measured: 4th exercise session, an average of 4 weeks post enrollment
Stiffness
Scar elasticity/hardness/stiffness by durometry (N/m) of the HTS before and after paraffin wax between the paraffin and no paraffin groups.
Minimum: 0 Maximum: 300 Higher score is a worse outcome.
Measured: 4th exercise session, an average of 4 weeks post enrollment
Pain visual analog scale
Pain visual analog scales (score) before and after paraffin wax between the paraffin and no paraffin groups.
Minimum: 0 Maximum: 100 Higher score is a worse outcome.
Measured: 4th exercise session, an average of 4 weeks post enrollment
Itch visual analog scale
Itch visual analog scales (score) before and after paraffin wax between the paraffin and no paraffin groups.
Minimum: 0 Maximum: 100 Higher score is a worse outcome.
Measured: 4th exercise session, an average of 4 weeks post enrollment
Scar surface temperature
Scar surface temperature (degrees celsius) before and after paraffin wax by scanner between the paraffin and no paraffin groups.
Minimum: 0 Maximum: 100 Higher score is a worse outcome.
Measured: 4th exercise session, an average of 4 weeks post enrollment
Patient and observer scar assessment scale
Pre and Post Study Patient and observer scar assessment scale (POSAS) version 3.0 pre and post paraffin at the first session and session four between the paraffin and no paraffin groups.
Minimum: 0 Maximum: 10 Higher score is a worse outcome.
Measured: 4th exercise session, an average of 4 weeks post enrollment
Perfusion
•Laser doppler imaging of perfusion (perfusion units) before and after paraffin wax first session only between the paraffin and no paraffin groups.
Minimum: 0 Maximum: 500 Higher score is a worse outcome.
Measured: 4th exercise session, an average of 4 weeks post enrollment
Lower extremities functional scale
- Pre (session 1) and Post (final session) study Lower extremity functional scale (LEFS) (score) between the paraffin and no paraffin groups.
Minimum: 0 Maximum: 80 Lower score is a worse outcome.
Measured: 4th exercise session, an average of 4 weeks post enrollment
Disabilities of the shoulder and hand
- Pre (session 1) and Post (final session) study disabilities of the arm, shoulder, and hand (DASH) (score) between the paraffin and no paraffin groups.
Minimum: 30 Maximum: 150 Higher score is a worse outcome.
Measured: 4th exercise session, an average of 4 weeks post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start6 Jan 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bonnie Carney, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786884
- Sponsor's protocol ID
- STUDY00007987
- Status last verified
- Jun 2025
- First submitted
- 6 Jan 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Randomized Controlled Trial Evaluating the Effectiveness of Paraffin Wax On Burn Patient Function, Range of Motion and Scar
- ClinicalTrials.gov ID
- NCT06786884
- Acronym / sponsor ID
- STUDY00007987
- Conditions
- Burn, Scar, Exercise Therapy
- Keywords
- paraffin wax, burn scar, scar, burn, range of motion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 22 Jan 2025 (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.
This study is being done to test if paraffin wax can be used to improve the range of motion and function for scars across joints when used in combination with scar rehabilitation therapy sessions. For those randomized to receive it, the paraffin wax will be used alongside the participants' exercise therapy treatments. Currently, treatments that are used in addition to rehabilitation therapy for increasing range of motion across joints in the burn population are limited. By getting more information about how paraffin wax may or may not work, patients in the future that have scars may be able to be helped.
Detailed description
If the participants agree to take part in this study, the participants scars will be looked at and the investigators will select one site that will be involved in the research. The scar will be "randomized" to the paraffin wax or no paraffin wax groups. The treatment the participants get will be chosen by chance, like flipping a coin. Neither the participants nor the study doctor will choose what treatment you get. The participants will have a 50% chance of being given either paraffin wax or not.
The study will take place in an outpatient setting. The participants will not be admitted to the hospital overnight. All patients who enter the study will be required to follow-up for regular appointments with their burn department.
Before the participants begin treatment, the participants will come in for a pre-treatment visit where the investigators will collection information about the participants scars such as pictures, range of motion measurements, non-invasive probes, non-invasive imaging (Laser doppler imaging) and questionnaires. These questionnaires will be related to the symptoms, range of motion, function, and appearance of the participants' burn scars. At the pre-treatment visit, there is an also an optional blood draw where less than 2 tablespoons of blood are collected. It is estimated this visit will take less than 1 hour. The investigators will also collect information from the medical record about prior surgical and medical history.
Exercise treatments (which the participants have previously chosen to undergo in talking with the participants doctor) will occur approximately in 1-2-week intervals depending on what the Burn Center scheduling department allows. For completion of this study, the participants will undergo 4 exercise therapy sessions which may take about 8 weeks.
At each visit, the following measurements will be captured before and after each exercise session. Those assigned to the paraffin wax group will have an additional assessment collected before their exercise therapy session and after the paraffin wax has been removed. Measurements at each visit include active and passive range of motion measurements of the affected joint, non-invasive probe measurements to measure water loss and hardness of your scar and the adjacent area of normal skin, digital photography, non-invasive laser doppler imaging (LDI), surface-level skin temperature measurements using either an infrared thermometer or skin temperature strip as well as pain and itch rating scales.
When applicable, the paraffin wax will be applied to the top of the scar for 15 minutes and repeat measurements previously listed above will be collected before your standard of care rehabilitation session. These sessions conducted by the burn rehab therapist may include scar massage, exercises, and functional activity. Specific treatments will be documented.
At each study visit, photographs will be taken of the study designated scar. All photographs taken for the purpose of this study will be taken by a high-resolution study camera. Photographs will be labeled with your study ID number. All efforts will be made to minimize the amount of identifiable information such as the participants' face or tattoos in these photos.
The procedures/treatments in this study that are considered experimental/investigation are: the use of the study product (paraffin wax) to assess the effect on burn scar that crosses an extremity joint during rehabilitation exercises.
The following procedures are part of the research study and would not normally be done as part of routine care: study provided paraffin wax and control application to the scar, scar assessments, digital photography, LDI, non-invasive imaging and measurements. These procedures are part of the study and will not be charged to insurance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Therapy Only | Other | Device: standard of care exercise therapy |
| Exercise Therapy with Paraffin Wax Treatment | Experimental | Device: paraffin wax, Device: standard of care exercise therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients with burn scar that crosses an upper or lower extremity joint (shoulder, elbow, wrist, hand, hip, knee, ankle)
- Patients that have been prescribed a rehabilitation program where paraffin wax could be used as an adjunct to rehab exercise therapy
Key exclusion criteria (4 listed)
- Adults unable to provide informed consent
- Injury etiology other than burn (ex: cutaneous trauma, cold injury, etc.)
- Pregnant women
- Prisoners
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 |
|---|---|---|
| paraffin waxThis is the treatment group that will receive exercise and paraffin wax | Device | Exercise Therapy with Paraffin Wax Treatment |
| standard of care exercise therapyThis is the group that will only receive exercise therapy and no paraffin wax. | Device | Exercise Therapy Only, Exercise Therapy with Paraffin Wax Treatment |
Primary outcome
Range of motion
Time frame: 4th exercise session, an average of 4 weeks post enrollment
Range of motion (degrees) of the affected joint before and after paraffin wax between the paraffin and no paraffin groups
9 secondary outcomes
Trans-epidermal water loss
Time frame: 4th exercise session, an average of 4 weeks post enrollment
Stiffness
Time frame: 4th exercise session, an average of 4 weeks post enrollment
Pain visual analog scale
Time frame: 4th exercise session, an average of 4 weeks post enrollment
Itch visual analog scale
Time frame: 4th exercise session, an average of 4 weeks post enrollment
Scar surface temperature
Time frame: 4th exercise session, an average of 4 weeks post enrollment
Patient and observer scar assessment scale
Time frame: 4th exercise session, an average of 4 weeks post enrollment
Perfusion
Time frame: 4th exercise session, an average of 4 weeks post enrollment
Lower extremities functional scale
Time frame: 4th exercise session, an average of 4 weeks post enrollment
Disabilities of the shoulder and hand
Time frame: 4th exercise session, an average of 4 weeks post enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- 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.
MedStar Washington Hosptial Center
Washington D.C., United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paraffin wax in people with Burn and Scar, run by Medstar Health Research Institute 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: 4th exercise session, an average of 4 weeks post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2025.