Wound Closure TechniquesNCT01352533
Closure Techniques and Scar Appearance
A study testing Running polypropylene closure, Tissue Adhesive (Derma-Bond) and Subcuticular polyglactin-910 combined with tissue adhesive in people with Wound Closure Techniques, run by Northwestern University.
Trial summary
The goal of this study is to assess whether wound closure with skin adhesive or running stitches combined with skin adhesive will be superior to standard wound sutures. This is a split-wound study that will compare two methods of skin closure within one standard closure technique, thereby providing an internal control… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Closure Techniques
- What is being tested?
- Running polypropylene closure, Tissue Adhesive (Derma-Bond) and Subcuticular polyglactin-910 combined with tissue adhesive
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and over
- Linear closures on the head and neck, at least 3cm in length
- The subjects are in good health
- The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
Who cannot join
- Under 18 years of age
- Pregnancy or Lactation
- Subjects who are unable to understand the protocol or to give informed consent
- Subjects with mental illness
- Defects on the scalp
About this study
Official title: A Randomized Prospective Trial of 2-Octyl Cyanoacrylate (Derma-Bond) Tissue Adhesive Versus Running Subcuticular Suture Combined With Tissue Adhesive Versus Epidermal Sutures in Dermatologic Surgery Procedures of the Head and Neck
The goal of this study is to assess whether wound closure with skin adhesive or running stitches combined with skin adhesive will be superior to standard wound sutures. This is a split-wound study that will compare two methods of skin closure within one standard closure technique, thereby providing an internal control of running stitches within each wound. The investigators plan to measure outcomes by assessing for scar appearance, the incidence of wound opening, scar elasticity and subject satisfaction.
- Conditions
- Wound Closure Techniques
- Being tested
- Running polypropylene closure, Tissue Adhesive (Derma-Bond), Subcuticular polyglactin-910 combined with tissue adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Running polypropylene closureProcedure or surgery
Half of every wound will be closed with Standard of Care running polypropylene sutures
Tissue Adhesive (Derma-Bond)Procedure or surgery
Approximately half of wounds will be randomized to be closed with tissue adhesive.
Subcuticular polyglactin-910 combined with tissue adhesiveProcedure or surgery
Approximately half of the experimental wounds will be randomized to be closed with a combination of subcuticular polyglactin-910 and tissue adhesive.
| Study group | Role | What they receive |
|---|---|---|
| Running polypropylene closure | Active comparator | Half of every linear wound will be closed with running polypropylene sutures. This technique is Standard of Care. Receives: Procedure: Running polypropylene closure |
| Tissue Adhesive (Derma-Bond) | Experimental | The experimental half of the wound will be randomized to receive closure with tissue adhesive alone. Receives: Procedure: Tissue Adhesive (Derma-Bond) |
| Subcuticular polyglactin-910 combined with tissue adhesive | Experimental | The experimental half of the wound will be randomized to receive closure with running subcuticular polyglactin-910 combined with tissue adhesive. Receives: Procedure: Subcuticular polyglactin-910 combined with tissue adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
The primary outcome measure of this study will be wound healing. This outcome will be assessed by the blinded observers, subject ratings and Cutometer measurements of scar elasticity. Two double-blinded dermatologists will be asked to rate the scars according to the objective scar scales at the 10 day/ 3 week and 3 month follow-up exams.
Measured: 10 day/3 weeks and 3 months
Secondary outcomes (3)
Dehiscence
The rate of dehiscence observed will be noted and recorded by the treating physicians.
Measured: 10 days/3 weeks and 3 months
Subject Satisfaction
The subjects will fill out the VAS to evaluate their overall assessment of their scar, any associated pruritus and pain. The subjects will also fill out a Subject Satisfaction Survey to evaluate subject preference for closure.
Measured: 10 days/3 weeks and 3 months
Adverse Events
The treating physicians will note occurrence and extent of any adverse events associated with either type of epidermal closure.
Measured: 10 days/3 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Closure TechniquesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352533
- Sponsor's protocol ID
- STU38040
- Status last verified
- Dec 2021
- First submitted
- 29 Apr 2011
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Trial of 2-Octyl Cyanoacrylate (Derma-Bond) Tissue Adhesive Versus Running Subcuticular Suture Combined With Tissue Adhesive Versus Epidermal Sutures in Dermatologic Surgery Procedures of the Head and Neck
- ClinicalTrials.gov ID
- NCT01352533
- Acronym / sponsor ID
- STU38040
- Conditions
- Wound Closure Techniques
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 12 May 2011 (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 goal of this study is to assess whether wound closure with skin adhesive or running stitches combined with skin adhesive will be superior to standard wound sutures. This is a split-wound study that will compare two methods of skin closure within one standard closure technique, thereby providing an internal control of running stitches within each wound. The investigators plan to measure outcomes by assessing for scar appearance, the incidence of wound opening, scar elasticity and subject satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Running polypropylene closure | Active comparator | Procedure: Running polypropylene closureHalf of every linear wound will be closed with running polypropylene sutures. This technique is Standard of Care. |
| Tissue Adhesive (Derma-Bond) | Experimental | Procedure: Tissue Adhesive (Derma-Bond)The experimental half of the wound will be randomized to receive closure with tissue adhesive alone. |
| Subcuticular polyglactin-910 combined with tissue adhesive | Experimental | Procedure: Subcuticular polyglactin-910 combined with tissue adhesiveThe experimental half of the wound will be randomized to receive closure with running subcuticular polyglactin-910 combined with tissue adhesive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 and over
- Linear closures on the head and neck, at least 3cm in length
- The subjects are in good health
- The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
Key exclusion criteria (5 listed)
- Under 18 years of age
- Pregnancy or Lactation
- Subjects who are unable to understand the protocol or to give informed consent
- Subjects with mental illness
- Defects on the scalp
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 |
|---|---|---|
| Running polypropylene closureHalf of every wound will be closed with Standard of Care running polypropylene sutures | Procedure or surgery | Running polypropylene closure |
| Tissue Adhesive (Derma-Bond)Approximately half of wounds will be randomized to be closed with tissue adhesive. | Procedure or surgery | Tissue Adhesive (Derma-Bond) |
| Subcuticular polyglactin-910 combined with tissue adhesiveApproximately half of the experimental wounds will be randomized to be closed with a combination of subcuticular polyglactin-910 and tissue adhesive. | Procedure or surgery | Subcuticular polyglactin-910 combined with tissue adhesive |
Primary outcome
Wound Healing
Time frame: 10 day/3 weeks and 3 months
The primary outcome measure of this study will be wound healing. This outcome will be assessed by the blinded observers, subject ratings and Cutometer measurements of scar elasticity. Two double-blinded dermatologists will be asked to rate the scars according to the objective scar scales at the 10 day/ 3 week and 3 month follow-up exams.
3 secondary outcomes
Dehiscence
Time frame: 10 days/3 weeks and 3 months
Subject Satisfaction
Time frame: 10 days/3 weeks and 3 months
Adverse Events
Time frame: 10 days/3 weeks and 3 months
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 6 Dec 2021.
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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.
Murad Alam, MD principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A study testing Running polypropylene closure, Tissue Adhesive (Derma-Bond) and Subcuticular polyglactin-910 combined with tissue adhesive in people with Wound Closure Techniques, run by Northwestern University.
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: withdrawn, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Wound Healing (time frame: 10 day/3 weeks and 3 months). 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 6 Dec 2021.