CicatrixNCT00938691
Optimal Suture Choice for Improved Scar Outcomes
A study testing Intradermal Suture in people with Cicatrix, run by Dallas VA Medical Center at 1 site in United States.
Trial summary
Certain parts of the body, such as the chest, back, and shoulders, are notorious for producing cosmetically poor scars after cutaneous surgery. While very little research has been done to understand these poor outcomes, it is generally thought that increased tension across the skin inherent to these body areas leads… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cicatrix
- What is being tested?
- Intradermal Suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jul 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring excision of a lesion on chest, back, or shoulders
Who cannot join
- History of ionizing radiation
- History of keloid or hypertrophic scarring
- History of or current internal malignancy
- History of bleeding disorder
- History of collagen or elastin disorder
- Current use of immunosuppressive medications
Trial locations and contacts
1 site in 1 country.
About this study
Certain parts of the body, such as the chest, back, and shoulders, are notorious for producing cosmetically poor scars after cutaneous surgery. While very little research has been done to understand these poor outcomes, it is generally thought that increased tension across the skin inherent to these body areas leads to significant widening of the final scar. Historically, the only way to combat this tension was to support the deeper portion of the wound with sutures that dissolve over several weeks. However, scars take many months to fully develop their greatest strength. So even with the standard technique, wounds in areas of high tension still show spreading of the scar with time. The investigators believe that these wounds require an extended duration of support throughout the scar's maturation period. Until recently, there did not exist a suture that could provide this long duration of support without also carrying the risk of the body rejecting it. Recently, a new extremely long acting absorbable biomaterial has been FDA approved for use as a suture. The investigators plan to use this suture to test the theory that alleviating stress on high tension wounds throughout the period which they gain their maximal integrity produces less scar spread and ultimately better cosmetic outcomes.
- Conditions
- Cicatrix
- Being tested
- Intradermal Suture
- Keywords
- Scar, Appearance, Spread
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradermal SutureProcedure or surgery
Intradermal SutureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Tepha | Experimental | Not described Receives: Procedure: Intradermal Suture |
| Vicryl | Active comparator | Not described Receives: Procedure: Intradermal Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar spread
Measured: 3 months and 1 year
Secondary outcomes (1)
Scar appearance
Measured: 3 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2010 (estimated)
- Study completionJul 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CicatrixStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dallas VA Medical Center
- Sponsor type
- US federal agency
- Investigators
- Kevin F Kia, MD, Study director, Dermatology, UT-Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938691
- Sponsor's protocol ID
- ASDS-45322
- Status last verified
- Jul 2009
- First submitted
- 13 Jul 2009
- Last updated
- 14 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kia KF, Burns MV, Vandergriff T, Weitzul S. Prevention of scar spread on trunk excisions: a rater-blinded randomized controlled trial. JAMA Dermatol. 2013 Jun;149(6):687-91. doi: 10.1001/jamadermatol.2013.3004.
PubMed 23752288
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Suture Choice for Improved Scar Outcomes
- ClinicalTrials.gov ID
- NCT00938691
- Acronym / sponsor ID
- ASDS-45322
- Conditions
- Cicatrix
- Keywords
- Scar, Appearance, Spread
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Dallas VA Medical CenterUS federal agency
- Study start
- Apr 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 14 Jul 2009 (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.
Certain parts of the body, such as the chest, back, and shoulders, are notorious for producing cosmetically poor scars after cutaneous surgery. While very little research has been done to understand these poor outcomes, it is generally thought that increased tension across the skin inherent to these body areas leads to significant widening of the final scar. Historically, the only way to combat this tension was to support the deeper portion of the wound with sutures that dissolve over several weeks. However, scars take many months to fully develop their greatest strength. So even with the standard technique, wounds in areas of high tension still show spreading of the scar with time. The investigators believe that these wounds require an extended duration of support throughout the scar's maturation period. Until recently, there did not exist a suture that could provide this long duration of support without also carrying the risk of the body rejecting it. Recently, a new extremely long acting absorbable biomaterial has been FDA approved for use as a suture. The investigators plan to use this suture to test the theory that alleviating stress on high tension wounds throughout the period which they gain their maximal integrity produces less scar spread and ultimately better cosmetic outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tepha | Experimental | Procedure: Intradermal Suture |
| Vicryl | Active comparator | Procedure: Intradermal Suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring excision of a lesion on chest, back, or shoulders
Key exclusion criteria (6 listed)
- History of ionizing radiation
- History of keloid or hypertrophic scarring
- History of or current internal malignancy
- History of bleeding disorder
- History of collagen or elastin disorder
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 |
|---|---|---|
| Intradermal Suture | Procedure or surgery | Tepha |
| Intradermal Suture | Procedure or surgery | Vicryl |
Primary outcome
Scar spread
Time frame: 3 months and 1 year
1 secondary outcome
Scar appearance
Time frame: 3 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2009.
- Derived from this study: PubMed 23752288Kia KF, Burns MV, Vandergriff T, Weitzul S. Prevention of scar spread on trunk excisions: a rater-blinded randomized controlled trial. JAMA Dermatol. 2013 Jun;149(6):687-91. doi: 10.1001/jamadermatol.2013.3004.
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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. This study is not recruiting at the moment.
Kevin F Kia, MD study director
Dermatology, UT-Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradermal Suture in people with Cicatrix, run by Dallas VA Medical Center 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 1 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: status not confirmed, as of the sponsor's last update on 14 Jul 2009. 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?
Results are not available in the source record.
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?
Scar spread (time frame: 3 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00938691, which also lists 1 linked publication.
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 14 Jul 2009.