Wound Closure TechniquesNCT02383186
Dermal Suturing Only Versus Layered Cutaneous Closure
A study testing Dermal Suturing Only Wound Closure and Layered Cutaneous Wound Closure in people with Wound Closure Techniques, run by University of California, Davis.
Trial summary
The purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Closure Techniques
- What is being tested?
- Dermal Suturing Only Wound Closure and Layered Cutaneous Wound Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 28 May 2014to Apr 2016
- 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
- Able to give informed consent themselves
- Patient scheduled for cutaneous surgical procedure with predicted linear closure
- Willing to return for follow up visits
Who cannot join
- Mentally handicapped
- Incarceration
- Pregnant Women
- Wounds with predicted closure length less than 3 cm
- Wounds unable to be fully closed via primary closure
About this study
Official title: Dermal Suturing Only Versus Layered Cutaneous Closure: A Randomized Split Wound Comparative Effectiveness Trial
The purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure.
Read the detailed description
The purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure. Our aims are to compare outcomes using a split wound model, where half the wound is sutured with one technique and the other half is sutured with the other. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wounds with a single layer closure will result in cosmetically superior wound outcomes.
- Conditions
- Wound Closure Techniques
- Being tested
- Dermal Suturing Only Wound Closure, Layered Cutaneous Wound Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermal Suturing Only Wound ClosureProcedure or surgery
The side assigned to dermal suturing only will be closed with a single layer of deep absorbable sutures. The method will be buried vertical mattress or set-back suturing at the surgeons discretion.
Layered Cutaneous Wound ClosureProcedure or surgery
The side assigned to layered closure is closed with 5-0 fast acting gut.
| Study group | Role | What they receive |
|---|---|---|
| Dermal Suturing Only Wound Closure | Active comparator | The side assigned to dermal suturing only will be closed with a single layer of deep absorbable sutures. The method will be buried vertical mattress or set-back suturing at the surgeons discretion. Receives: Procedure: Dermal Suturing Only Wound Closure; Procedure: Layered Cutaneous Wound Closure |
| Layered Cutaneous Wound Closure | Active comparator | The side assigned to layered closure is closed with 5-0 fast acting gut. Receives: Procedure: Dermal Suturing Only Wound Closure; Procedure: Layered Cutaneous Wound Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Scar on the Patient and Observer Scar Assessment Scale at 3 Months
After surgical procedure, half of the subject's wound will be closed by single layer suturing, while the other half is closed by layered cutaneous closure. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
Measured: 3 months
Assessment of Scar on the Patient and Observer Scar Assessment Scale at 12 Months
After surgical procedure, half of the subject's wound will be closed by single layer suturing, while the other half is closed by layered cutaneous closure. After 12 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
Measured: 12 months
Secondary outcomes (2)
Measurement of Scar Width
The width of the scar will be measured 1 centimeter from the midline on both sides. There is no defined width that is considered satisfactory or not satisfactory. The measurements will be compared between subjects.
Measured: 3 months and 12 months
Assessment of Complications
Noting the presence or absence of bleeding, dehiscence, infection or spitting sutures.
Measured: 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study start28 May 2014
- Primary completionApr 2016
- Study completionApr 2016
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Eisen, M.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383186
- Sponsor's protocol ID
- 614521
- Status last verified
- Jul 2017
- First submitted
- 10 Nov 2014
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermal Suturing Only Versus Layered Cutaneous Closure: A Randomized Split Wound Comparative Effectiveness Trial
- ClinicalTrials.gov ID
- NCT02383186
- Acronym / sponsor ID
- 614521
- Conditions
- Wound Closure Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 28 May 2014 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 9 Mar 2015 (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 purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure.
Detailed description
The purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure. Our aims are to compare outcomes using a split wound model, where half the wound is sutured with one technique and the other half is sutured with the other. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wounds with a single layer closure will result in cosmetically superior wound outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermal Suturing Only Wound Closure | Active comparator | Procedure: Dermal Suturing Only Wound Closure, Procedure: Layered Cutaneous Wound ClosureThe side assigned to dermal suturing only will be closed with a single layer of deep absorbable sutures. The method will be buried vertical mattress or set-back suturing at the surgeons discretion. |
| Layered Cutaneous Wound Closure | Active comparator | Procedure: Dermal Suturing Only Wound Closure, Procedure: Layered Cutaneous Wound ClosureThe side assigned to layered closure is closed with 5-0 fast acting gut. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to give informed consent themselves
- Patient scheduled for cutaneous surgical procedure with predicted linear closure
- Willing to return for follow up visits
Key exclusion criteria (5 listed)
- Mentally handicapped
- Incarceration
- Pregnant Women
- Wounds with predicted closure length less than 3 cm
- Wounds unable to be fully closed via primary closure
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 |
|---|---|---|
| Dermal Suturing Only Wound ClosureThe side assigned to dermal suturing only will be closed with a single layer of deep absorbable sutures. The method will be buried vertical mattress or set-back suturing at the surgeons discretion. | Procedure or surgery | Dermal Suturing Only Wound Closure, Layered Cutaneous Wound Closure |
| Layered Cutaneous Wound ClosureThe side assigned to layered closure is closed with 5-0 fast acting gut. | Procedure or surgery | Dermal Suturing Only Wound Closure, Layered Cutaneous Wound Closure |
Primary outcome
Assessment of Scar on the Patient and Observer Scar Assessment Scale at 3 Months
Time frame: 3 months
After surgical procedure, half of the subject's wound will be closed by single layer suturing, while the other half is closed by layered cutaneous closure. After 3 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
Assessment of Scar on the Patient and Observer Scar Assessment Scale at 12 Months
Time frame: 12 months
After surgical procedure, half of the subject's wound will be closed by single layer suturing, while the other half is closed by layered cutaneous closure. After 12 months, subjects will return to clinic for evaluation of the cosmesis of both types of closure techniques.
2 secondary outcomes
Measurement of Scar Width
Time frame: 3 months and 12 months
Assessment of Complications
Time frame: 3 months and 12 months
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 18 Jul 2017.
- University of California-Davis Department of Dermatology Clinical ResearchLink provided by the sponsor.
Related trials for Wound Closure Techniques
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Not yet recruiting
The Tooth Collar Technique
Insufficient Bone Volume Prior to Implant Surgery
Not yet recruiting
Skin Closure in Prosthetic Joint Surgery: Comparative Evaluation of the "Barbed Sutures and Skin Glue" Technique (Cica-Pro)
Surgical Wound, Knee Arthroplasty
Recruiting
Oral Antibiotics vs. No Antibiotics in Pediatric Colorectal Surgery
Bowel Cleansing Prior to Clinical Procedures, Colorectal Anastomosis
Not yet recruiting
Primary Versus Delayed Wound Closure in Complicated Appendectomy (The HIEDI-Yemen Trial)
Appendicitis, Surgical Wound Infection
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.
Daniel Eisen, M.D. principal investigator
University of California, Davis
Questions about this trial
What is this clinical trial studying?
A study testing Dermal Suturing Only Wound Closure and Layered Cutaneous Wound Closure in people with Wound Closure Techniques, run by University of California, Davis.
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 3 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 18 Jul 2017. 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 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?
Assessment of Scar on the Patient and Observer Scar Assessment Scale at 3 Months (time frame: 3 months). 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 18 Jul 2017.