Burn ScarNCT01075165
Efficacy of Spray Silicone in Alteration of Burn Scar
A study testing silicone spray and saline spray in people with Burn Scar, run by United States Army Institute of Surgical Research at 2 sites in United States.
Trial summary
In a burn population, conduct a prospective, double-blinded, randomized, controlled clinical trial to determine the ability of spray silicone to alter the physical characteristics of burn scar compared to a placebo. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Burn Scar
- What is being tested?
- silicone spray and saline spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Dec 2014
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Military or civilian
- Between 18-60 years of age
- Subjects have experienced a deep partial thickness burn injury with a minimal size 2x6 inches in dimension
- Burn wounds must have healed by secondary intention
- Available for initial scar evaluation and bi-weekly assessments (30 minutes) and application of silicone and saline every weekday (5 minutes)
Who cannot join
- <18 or >60 years
- Available burn scar size is less then 2x6 inches
- Burn wounds healed by sheet grafting
- Unavailable for initial scar evaluation and bi-weekly assessments (30 minutes) and application of silicone and saline every weekday (5 minutes)
- Pre-existing medical conditions that have the potential to impair healing (i.e. Diabetes, Peripheral Arterial Disease, etc).
- Pregnant women will be excluded from the study because of the potential for pregnancy hormones to exacerbate the burn scar
Trial locations and contacts
2 sites in 1 country.
United States2 sites
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234
USAISR
Fort Sam Houston, Texas, 78234
About this study
Official title: The Efficacy of Spray Silicone in the Alteration of Physical Burn Scar Characteristics: A Double Blinded Randomized Controlled Trial
In a burn population, conduct a prospective, double-blinded, randomized, controlled clinical trial to determine the ability of spray silicone to alter the physical characteristics of burn scar compared to a placebo.
Read the detailed description
At study enrollment, the patient's scar will be evaluated using the vascularity category of the Vancouver Scar Scale. The vascularity rating is a four item likert scale that rates the scar as normal (0), pink (1), red (2), or purple (3). Scar height will be measured using a diagnostic ultrasound unit with a 20MHz transducer.27 Digital photographs will be taken with a color spectrum scale placed next to the scar. Laser Doppler imaging (LDI) will be used to assess scar perfusion at the regions of interest to determine whether treatment with silicone spay results in measureable changes in scar perfusion as well as to establish the time course over which these changes may be expected to occur. A spray template will then be created for the patient using thermoplastic material. It will consist of three (3) circles with an area of .785 inches, spaced one inch apart, which will section off the test areas. One of the areas will be treated with the spray silicone, one area will be sprayed with spray saline (to serve as a placebo), the remaining area will not be treated and therefore will serve as the control. The order in which each area is treated will be determined using a randomized block, computerized allocation developed by the study statistician. The spray silicone and spray saline will be applied via containers that conceal the contents and the patients will not be allowed to observe the application of the silicone or saline. Although the patient will be blinded to the test areas that have substances applied to them, there will be no blinding in regard to the control area that receives no treatment. The substances will be applied by trained investigators each weekday for a 12-week period to ensure the method of application is consistent. Both substances will be applied at a distance of 1.5 inches from the surface of the skin for a one second period. Patients will be instructed not to wash the treated area for 24 hours and not to apply pressure garments over the area. The treated areas will be re-evaluated and photographed every two weeks for a 12 week period. The clinician conducting the initial scar evaluation and re-evaluations will be blinded to the scar treatment. Each patient will also complete a scar assessment scale.28 The patient's participation in the study will be concluded 12 weeks after the initial treatment and he/she will be given the option of continued use of the spray silicone, resumption/commencement of pressure garment use or the provision of another appropriate scar management program. Because burn scar can take several months to years to reach the scar maturation phase, the patient will still be a candidate for an alternate scar management program if at the conclusion of this study they see no benefit from the use of spray silicone. If at any time during the 12-week period the clinician determines that the scar is worsening, then the patient will be removed from the study and offered another scar management program.
- Conditions
- Burn Scar
- Being tested
- silicone spray, saline spray
- Keywords
- silicone, burn scar, hypertrophic scar, keloid, scar assessment, abnormal scarring, Burn patients
- Medical subject headings
- Cicatrix, Hypertrophic, Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silicone sprayOther
application of silicone spray to predefined area qd 12 weeks
saline sprayOther
application of saline spray to predefined area qd 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Silicone Spray | Experimental | Apply spray silicone Receives: Other: silicone spray |
| Saline Spray | Placebo comparator | Apply Saline Spray Receives: Other: saline spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascularity rating, scar height, and color of burn scar (spray silicone vs placebo vs untreated)
Measured: every 2 weeks for a 12 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startMar 2011
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: IRB closed study due to no enrollment over 4 yrs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn ScarStudies 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075165
- Sponsor's protocol ID
- H-09-041
- Status last verified
- Feb 2015
- First submitted
- 23 Feb 2010
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Spray Silicone in the Alteration of Physical Burn Scar Characteristics: A Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01075165
- Acronym / sponsor ID
- H-09-041
- Conditions
- Burn Scar
- Keywords
- silicone, burn scar, hypertrophic scar, keloid, scar assessment, abnormal scarring, Burn patients
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB closed study due to no enrollment over 4 yrs
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Study start
- Mar 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Feb 2010 (estimated)
- 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.
In a burn population, conduct a prospective, double-blinded, randomized, controlled clinical trial to determine the ability of spray silicone to alter the physical characteristics of burn scar compared to a placebo.
Detailed description
At study enrollment, the patient's scar will be evaluated using the vascularity category of the Vancouver Scar Scale. The vascularity rating is a four item likert scale that rates the scar as normal (0), pink (1), red (2), or purple (3). Scar height will be measured using a diagnostic ultrasound unit with a 20MHz transducer.27 Digital photographs will be taken with a color spectrum scale placed next to the scar. Laser Doppler imaging (LDI) will be used to assess scar perfusion at the regions of interest to determine whether treatment with silicone spay results in measureable changes in scar perfusion as well as to establish the time course over which these changes may be expected to occur. A spray template will then be created for the patient using thermoplastic material. It will consist of three (3) circles with an area of .785 inches, spaced one inch apart, which will section off the test areas. One of the areas will be treated with the spray silicone, one area will be sprayed with spray saline (to serve as a placebo), the remaining area will not be treated and therefore will serve as the control. The order in which each area is treated will be determined using a randomized block, computerized allocation developed by the study statistician. The spray silicone and spray saline will be applied via containers that conceal the contents and the patients will not be allowed to observe the application of the silicone or saline. Although the patient will be blinded to the test areas that have substances applied to them, there will be no blinding in regard to the control area that receives no treatment. The substances will be applied by trained investigators each weekday for a 12-week period to ensure the method of application is consistent. Both substances will be applied at a distance of 1.5 inches from the surface of the skin for a one second period. Patients will be instructed not to wash the treated area for 24 hours and not to apply pressure garments over the area. The treated areas will be re-evaluated and photographed every two weeks for a 12 week period. The clinician conducting the initial scar evaluation and re-evaluations will be blinded to the scar treatment. Each patient will also complete a scar assessment scale.28 The patient's participation in the study will be concluded 12 weeks after the initial treatment and he/she will be given the option of continued use of the spray silicone, resumption/commencement of pressure garment use or the provision of another appropriate scar management program. Because burn scar can take several months to years to reach the scar maturation phase, the patient will still be a candidate for an alternate scar management program if at the conclusion of this study they see no benefit from the use of spray silicone. If at any time during the 12-week period the clinician determines that the scar is worsening, then the patient will be removed from the study and offered another scar management program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silicone Spray | Experimental | Other: silicone sprayApply spray silicone |
| Saline Spray | Placebo comparator | Other: saline sprayApply Saline Spray |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Military or civilian
- Between 18-60 years of age
- Subjects have experienced a deep partial thickness burn injury with a minimal size 2x6 inches in dimension
- Burn wounds must have healed by secondary intention
- Available for initial scar evaluation and bi-weekly assessments (30 minutes) and application of silicone and saline every weekday (5 minutes)
Key exclusion criteria (6 listed)
- <18 or >60 years
- Available burn scar size is less then 2x6 inches
- Burn wounds healed by sheet grafting
- Unavailable for initial scar evaluation and bi-weekly assessments (30 minutes) and application of silicone and saline every weekday (5 minutes)
- Pre-existing medical conditions that have the potential to impair healing (i.e. Diabetes, Peripheral Arterial Disease, etc).
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 |
|---|---|---|
| silicone sprayapplication of silicone spray to predefined area qd 12 weeks | Other | Silicone Spray |
| saline sprayapplication of saline spray to predefined area qd 12 weeks | Other | Saline Spray |
Primary outcome
Vascularity rating, scar height, and color of burn scar (spray silicone vs placebo vs untreated)
Time frame: every 2 weeks for a 12 week period
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 4 Feb 2015.
Related trials for Burn Scar
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruitingObservational study
Recurrence of Extremity Joint Contracture After Z-Plasty Versus Full-Thickness Skin Graft
Joint Contracture, Contracture
RecruitingPhase 3
Novel Strategies for Reducing Burn Scar Itch
Burn Scar, Itch Scarring
RecruitingPhase 2/3
Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients
Burn Scar, Burn Wound
Not yet recruiting
Tools for Return of Facial Function
Facial Scarring, Facial Trauma
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing silicone spray and saline spray in people with Burn Scar, run by United States Army Institute of Surgical Research 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 5 inclusion and 6 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 4 Feb 2015. 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. Some participants in this study may receive a placebo. 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?
Vascularity rating, scar height, and color of burn scar (spray silicone vs placebo vs untreated) (time frame: every 2 weeks for a 12 week period). 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 4 Feb 2015.