Efficacy of Spray Silicone in Alteration of Burn Scar

This study is currently recruiting participants.
Verified September 2013 by United States Army Institute of Surgical Research
Sponsor:
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT01075165
First received: February 23, 2010
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Burn Scar
Other: silicone spray
Other: saline spray

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Spray Silicone in the Alteration of Physical Burn Scar Characteristics: A Double Blinded Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Silicone Spray
Apply spray silicone
Other: silicone spray
application of silicone spray to predefined area qd 12 weeks
Other Name: Silicone Spray
Placebo Comparator: Saline Spray
Apply Saline Spray
Other: saline spray
application of saline spray to predefined area qd 12 weeks
Other Name: Saline spray

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075165

Locations
United States, Texas
US Army Institute of Surgical Research Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Donald Hawkins, PT, DPT    210-916-1440    donald.hawkins@amedd.army.mil   
Contact: Annette R. McClinton, RN, MA    210-539-2834    annette.mcclinton@amedd.army.mil   
Principal Investigator: Donald Hawkins, PT, DPT         
USAISR Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Donald Hawkins, PhD    210-916-1440    donald.hawkins@amedd.army.mil   
Contact: annette R Mcclinton, MA, RN    210-916-2834    annette.r.mcclinton@us.army.mil   
Principal Investigator: Donald Hawkins, PT, DPT         
Sponsors and Collaborators
United States Army Institute of Surgical Research
  More Information

No publications provided

Responsible Party: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT01075165     History of Changes
Other Study ID Numbers: H-09-041
Study First Received: February 23, 2010
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:
silicone
burn scar
hypertrophic scar
keloid
scar assessment
abnormal scarring
Burn patients

Additional relevant MeSH terms:
Burns
Cicatrix
Wounds and Injuries
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014