Hypertrophic ScarringNCT01602458
A Randomized Control Trial for Preventative Scar Management
A study testing Silicone Only Therapy (SOT) and Silicone Pressure Garment Therapy (SPGT) in people with Hypertrophic Scarring, run by Seton Healthcare Family at 1 site in United States.
Trial summary
The study's objective is to compare the global scar outcomes in those treated with silicone only therapy (SOT) versus silicone pressure garment therapy (SPGT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Hypertrophic Scarring
- What is being tested?
- Silicone Only Therapy (SOT) and Silicone Pressure Garment Therapy (SPGT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Nov 2013
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients who have undergone surgery within one month prior to enrollment
- patient must have a split-thickness or full thickness skin graft with extremity involvement secondary to a traumatic skin injury (burn, laceration, avulsion or de-gloving type injury) that has healed (based on clinician assessment of wound healing)
- patients with comorbid conditions
- patients must be referred to and attend scar management clinic at DCMC
Who cannot join
- patients with concave scars at the site of the skin graft
- patients with skin graft scars larger than 4x7 inches
- patients with presence of current skin infection or history of dermatological condition such as eczema
- patients with skin grafts only on parts of the body other than extremities
- patients with reported silicone allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
Dell Children's Medical Center of Central Texas
Austin, Texas, 78798
About this study
Official title: The Use of Pressure and Silicone in Children With Skin Grafts After Traumatic Skin Injury: A Randomized Control Trial for Preventative Scar Management
The study's objective is to compare the global scar outcomes in those treated with silicone only therapy (SOT) versus silicone pressure garment therapy (SPGT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury.
Read the detailed description
The goals of this study are to:
- Examine the difference between patient scores on the POSAS scale in those randomized to silicone pressure garment therapy (SPGT) versus silicone only therapy (SOT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury at baseline, 8, 16, and 24 weeks.
- Examine the difference between observer scores on the POSAS scale in those randomized to silicone pressure garment therapy (SPGT) versus silicone only therapy (SOT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury at baseline, 8, 16, and 24 weeks.
- Examine the difference between Vancouver scale in those randomized to silicone pressure garment therapy (SPGT) versus silicone only therapy (SOT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury at baseline, 8, 16, and 24 weeks.
- Examine the need for surgical intervention in those randomized to silicone pressure garment therapy (SPGT) versus silicone only therapy (SOT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury.
- Conditions
- Hypertrophic Scarring
- Being tested
- Silicone Only Therapy (SOT), Silicone Pressure Garment Therapy (SPGT)
- Keywords
- Preventative Scar Management, Skin Grafts, Silicone Therapy, Silicone Pressure Garment Therapy
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silicone Only Therapy (SOT)Procedure or surgery
SOT group will be instructed to wear the silicone for 23 hours/day, removing only for bathing. A new piece of Mepiform™ silicone should be replaced weekly and applied to clean, dry skin. Compression free medical tape will be used to secure the silicone in place. Patients will be provided with 6 months of topical silicone therapy. If optimal results are achieved prior to 6 months of therapy, the treatment will be discontinued. Patients will also be provided with Scar Management for Skin Grafts Homecare Instructions: Silicone.
Silicone Pressure Garment Therapy (SPGT)Procedure or surgery
SPGT group will be instructed to use the Mepiform™ silicone only for 2 weeks during the interim before final fitting with the custom compression garment. A new piece of Mepiform™ silicone should be replaced weekly and applied to clean, dry skin. The patients will be instructed to wear the silicone for 23 hours/day, removing only for bathing.
The patient will continue to use the Mepiform™ silicone under the compression garment for the entire length of the study. The garment will be replaced after 3 months of wear, in order to ensure that optimal pressure and silicone management is applied to the area. Patients will be provided with Scar Management for Skin Grafts Homecare Instructions: Silicone and Compression Garment.
| Study group | Role | What they receive |
|---|---|---|
| Silicone Only Therapy (SOT) | Other | Mepiform™ silicone will be utilized by SOT group. Receives: Procedure: Silicone Only Therapy (SOT) |
| Silicone Pressure Garment Therapy (SPGT) | Other | Mepiform™ silicone and custom compression garments fabricated by Barton Carey™ will be utilized by SPGT group. Receives: Procedure: Silicone Pressure Garment Therapy (SPGT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Observer Scar Assessment Scale (POSAS)
This scale incorporates the patient's/caregiver's perspective on their scar. It measures scar color, pliability, thickness, relief, itching, and pain scored by patient/caregiver. The observer scale measures vascularization, pigmentation, pliability, thickness, and relief.
Measured: Baseline, 8 weeks, 16 weeks, and 24 weeks
Vancouver Scar Scale (VSS)
This scale scores pigmentation, vascularity, pliability, and scar height with the sum of the scores that correlates with hypertrophic scars.
Measured: Baseline, 8 weeks, 16 weeks, and 24 weeks
Secondary outcomes (3)
Scar Management Research Intake Form
This form will include date of enrollment, randomization to group, age, race, gender, date of injury, type of injury, location of injury, type of graft, graft dimensions, date of surgery, date graft healed, number of days for graft to heal, date silicone started, date garment issued, and date silicone/garment discontinued.
Measured: Baseline through 24 weeks
Patient Compliance Log (PCL)
Patients will be given a daily log to record hours of compliance with intervention.
Measured: Baseline through 24 weeks
Photographs
The Physical/Occupational Therapists are to obtain de-identifiable photographs of the graft site at each visit, in order to have visual documentation of the wound healing process throughout the duration of the study.
Measured: Photographs will be collected at each visit (first visit, as well as at weeks 2, 4, 8, 12, 14, 16, 20, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startMay 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarringStudies 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
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seton Healthcare Family
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Weinfeld, MD, Principal investigator, Dell Children's Medical Center Rehabilitation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602458
- Sponsor's protocol ID
- CR-10-134
- Status last verified
- May 2019
- First submitted
- 10 May 2012
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Pressure and Silicone in Children With Skin Grafts After Traumatic Skin Injury: A Randomized Control Trial for Preventative Scar Management
- ClinicalTrials.gov ID
- NCT01602458
- Acronym / sponsor ID
- CR-10-134
- Conditions
- Hypertrophic Scarring
- Keywords
- Preventative Scar Management, Skin Grafts, Silicone Therapy, Silicone Pressure Garment Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seton Healthcare FamilyUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 21 May 2012 (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.
The study's objective is to compare the global scar outcomes in those treated with silicone only therapy (SOT) versus silicone pressure garment therapy (SPGT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury.
Detailed description
The goals of this study are to:
- Examine the difference between patient scores on the POSAS scale in those randomized to silicone pressure garment therapy (SPGT) versus silicone only therapy (SOT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury at baseline, 8, 16, and 24 weeks.
- Examine the difference between observer scores on the POSAS scale in those randomized to silicone pressure garment therapy (SPGT) versus silicone only therapy (SOT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury at baseline, 8, 16, and 24 weeks.
- Examine the difference between Vancouver scale in those randomized to silicone pressure garment therapy (SPGT) versus silicone only therapy (SOT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury at baseline, 8, 16, and 24 weeks.
- Examine the need for surgical intervention in those randomized to silicone pressure garment therapy (SPGT) versus silicone only therapy (SOT) for the prevention of hypertrophic scarring in children with skin grafts after traumatic skin injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silicone Only Therapy (SOT) | Other | Procedure: Silicone Only Therapy (SOT)Mepiform™ silicone will be utilized by SOT group. |
| Silicone Pressure Garment Therapy (SPGT) | Other | Procedure: Silicone Pressure Garment Therapy (SPGT)Mepiform™ silicone and custom compression garments fabricated by Barton Carey™ will be utilized by SPGT group. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- patients who have undergone surgery within one month prior to enrollment
- patient must have a split-thickness or full thickness skin graft with extremity involvement secondary to a traumatic skin injury (burn, laceration, avulsion or de-gloving type injury) that has healed (based on clinician assessment of wound healing)
- patients with comorbid conditions
- patients must be referred to and attend scar management clinic at DCMC
Key exclusion criteria (5 listed)
- patients with concave scars at the site of the skin graft
- patients with skin graft scars larger than 4x7 inches
- patients with presence of current skin infection or history of dermatological condition such as eczema
- patients with skin grafts only on parts of the body other than extremities
- patients with reported silicone allergies
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 Only Therapy (SOT)SOT group will be instructed to wear the silicone for 23 hours/day, removing only for bathing. A new piece of Mepiform™ silicone should be replaced weekly and applied to clean, dry skin. Compression free medical tape will be used to secure the silicone in place. Patients will be provided with 6 months of topical silicone therapy. If optimal results are achieved prior to 6 months of therapy, the treatment will be discontinued. Patients will also be provided with Scar Management for Skin Grafts Homecare Instructions: Silicone. | Procedure or surgery | Silicone Only Therapy (SOT) |
| Silicone Pressure Garment Therapy (SPGT)SPGT group will be instructed to use the Mepiform™ silicone only for 2 weeks during the interim before final fitting with the custom compression garment. A new piece of Mepiform™ silicone should be replaced weekly and applied to clean, dry skin. The patients will be instructed to wear the silicone for 23 hours/day, removing only for bathing. The patient will continue to use the Mepiform™ silicone under the compression garment for the entire length of the study. The garment will be replaced after 3 months of wear, in order to ensure that optimal pressure and silicone management is applied to the area. Patients will be provided with Scar Management for Skin Grafts Homecare Instructions: Silicone and Compression Garment. | Procedure or surgery | Silicone Pressure Garment Therapy (SPGT) |
Primary outcome
Patient Observer Scar Assessment Scale (POSAS)
Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks
This scale incorporates the patient's/caregiver's perspective on their scar. It measures scar color, pliability, thickness, relief, itching, and pain scored by patient/caregiver. The observer scale measures vascularization, pigmentation, pliability, thickness, and relief.
Vancouver Scar Scale (VSS)
Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks
This scale scores pigmentation, vascularity, pliability, and scar height with the sum of the scores that correlates with hypertrophic scars.
3 secondary outcomes
Scar Management Research Intake Form
Time frame: Baseline through 24 weeks
Patient Compliance Log (PCL)
Time frame: Baseline through 24 weeks
Photographs
Time frame: Photographs will be collected at each visit (first visit, as well as at weeks 2, 4, 8, 12, 14, 16, 20, and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
Related trials for Hypertrophic Scarring
Not yet recruitingPhase 2
Phase II Clinical Study on Preliminary Efficacy and Safety of ETD-001 Gel for Hypertrophic Scars
Hypertrophic Scars
Not yet recruiting
Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury
Recruiting
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Recruiting
AVAVA MIRIA General Use
Acne, Acne Scars - Mixed Atrophic and Hypertrophic
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.
Adam Weinfeld, MD principal investigator
Dell Children's Medical Center Rehabilitation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silicone Only Therapy (SOT) and Silicone Pressure Garment Therapy (SPGT) in people with Hypertrophic Scarring, run by Seton Healthcare Family 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: finished, as of the sponsor's last update on 20 May 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient Observer Scar Assessment Scale (POSAS) (time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks). The study lists 2 primary outcomes in all. 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 20 May 2019.