Efficacy of Spray Silicone in Alteration of Burn Scar

February 2, 2015 updated by: United States Army Institute of Surgical Research

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • USAISR
      • Fort Sam Houston, Texas, United States, 78234
        • US Army Institute of Surgical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Military or civilian
  2. Between 18-60 years of age
  3. Subjects have experienced a deep partial thickness burn injury with a minimal size 2x6 inches in dimension
  4. Burn wounds must have healed by secondary intention
  5. Available for initial scar evaluation and bi-weekly assessments (30 minutes) and application of silicone and saline every weekday (5 minutes)

Exclusion Criteria:

  1. <18 or >60 years
  2. Available burn scar size is less then 2x6 inches
  3. Burn wounds healed by sheet grafting
  4. Unavailable for initial scar evaluation and bi-weekly assessments (30 minutes) and application of silicone and saline every weekday (5 minutes)
  5. Pre-existing medical conditions that have the potential to impair healing (i.e. Diabetes, Peripheral Arterial Disease, etc).
  6. Pregnant women will be excluded from the study because of the potential for pregnancy hormones to exacerbate the burn scar

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Silicone Spray
Apply spray silicone
Other: silicone spray
application of silicone spray to predefined area qd 12 weeks
Placebo Comparator: Saline Spray
Apply Saline Spray
Other: saline spray
application of saline spray to predefined area qd 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
every 2 weeks for a 12 week period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
United States Army Institute of Surgical Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-09-041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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