Scar Quality Assessment and SafetyNCT05240820
A Comparative Study of Scar Quality and Safety According to Suture Materials Following Excision of Benign Tumors
A study testing multi-layer wound closure in people with Scar Quality Assessment and Safety, run by Korea University Guro Hospital.
Trial summary
Due to the rise in the incidence of giant benign tumors such as lipoma, excision of benign tumors on body have been performed by plastic surgeons. After excision of giant benign tumors, efforts should be include with a goal of achieving optimal cosmetic outcomes after subcutaneous and dermal sutures may be important… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Scar Quality Assessment and Safety
- What is being tested?
- multi-layer wound closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2022to 31 Aug 2023
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with benign tumors greater than 20cm2
- Patients with expected scar length (incision length) longer than 3cm
- Patients who need excision of benign tumors
Who cannot join
- Pregnancy, lactation, patients with previous scars around the benign tumors
- Patients with wound infection, human immunodeficiency virus positive
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Outcomes Associated With the Use of Polyglactin 910 (Vicryl®) and Polypropylene (Prolene®) Suture, and Polydioxanone (StratafixTM Spiral PDS® Plus) and Combination of 2-Octyl Cyanoacrylate and Polyester Mesh (Dermabond Prineo®) for Multi-Layer Wound Closure Following Excision of Giant Benign Tumors
Due to the rise in the incidence of giant benign tumors such as lipoma, excision of benign tumors on body have been performed by plastic surgeons. After excision of giant benign tumors, efforts should be include with a goal of achieving optimal cosmetic outcomes after subcutaneous and dermal sutures may be important to improve scar quality because suture methods might influence the final aesthetic outcome. Various absorbable suture materials have been used for tension-relieving deep sutures. Subcutaneous and dermal sutures using Polygalctin 910 (Vicryl®, Ethicon, Johnson and Johnson Ltd.), which is absorbable, synthetic, braided suture composed of a copolymer made from 90% glycolide and 10% L-lactide or polydioxanone (PDS®, Ethicon), which is composed of polyester and p-dioxanone with skin suture using polypropylene (Prolene®, Ethicon) have been commonly used after excision of tumors.
Although these sutures are particularly useful where combination of absorbable suture and extended wound support for up to six weeks is desirable, strong and secure skin sutures may be needed to improve scar quality following excision of tumors on back and abdomen due to their thick skins. However, increased wound closure times are their drawbacks. To overcome these drawbacks, a new subcutaneous suture material composed of polydioxanone, StratafixTM Spiral PDS II® and a new skin suture material using combination of 2-octyl cyanoacrylate and polyester mesh (Dermabond Prineo®, Ethicon) have been developed and skin sutures using combination of these two materials may be an alternative suture method to decrease wound closure times and improve scar quality for better wound closure with high-tension closure, favorable and encouraging results compared to traditional suture methods.
Although polyglactin 910, polydioxanone, polypropylene, and combination of 2-octyl cyanoacrylate and polyester mesh have been used in general surgery and neurosurgery, no studies on the clinical outcomes, specifically on scar quality after excision of tumors have been reported in plastic surgery. Therefore, the purpose of this study is to compare clinical outcomes associated with scar quality between the use of polyglactin 910 and polypropylene suture, and polydioxanone and combination of 2-octyl cyanoacrylate and polyester mesh for multi-layer wound closure following excision of giant benign tumors.
Read the detailed description
We prospectively analyze clinical outcome data from 30 subjects who perform multi-layer wound closure using polyglactin 910 (Vicryl®, Ethicon, Johnson and Johnson Ltd., NJ, USA) and polypropylene (Prolene®, Ethicon), and polydioxanone (StratafixTM Spiral PDS® Plus) and combination of 2-octyl cyanoacrylate and polyester mesh (Dermabond Prineo®) following excision of giant benign tumors. Patients are randomized into two groups: one sutured by polyglactin 910 and polypropylene and the other group sutured by polydioxanone and combination of 2-octyl cyanoacrylate and polyester mesh. For a group sutured by polyglactin 910 and polypropylene, deep dermal layer will be sutured by polyglactin 910 and polypropylene will be used for suture of superficial dermis and epidermis. For the other group sutured by polydioxanone and combination of 2-octyl cyanoacrylate and polyester mesh, deep dermal layer will be sutured by polydioxanone and polyester mesh will be applied for approximation of superficial dermal layer and epidermis.
A computer-generated list, created using random permuted blocks of 6, that is stratified by hospital will be used for randomization. The allocation configuration will be generated and concealed until interventions will be assigned by a secretary not involved in this trial. Patients with benign tumors greater than 20cm2 (expected scar length more than 3cm) will be included in this study. A Sonography or magnetic resonance imaging scan with millimeter slices will be performed to measure the size of the tumors.
Based on previous studies, the number of subjects was calculated in this study. The weighted scar quality was 2.85 ± 0.57 in one group and 1.96 ± 0.58 in the other group. The following values were used to calculate the number of subjects: Type I error (α) = 5%, power of test = 95%. Independent t-test was used to calculate sample size and differences between two independent means of two groups were used for calculation of sample size. Actual power was 0.954 and the calculation result of the sample size in each group was 10. Considering a drop-out rate of broadly 30%, the number of subjects in each group was 14.3 (=10/(1-0.30)) and a sample size of 30 (=15 × 2) randomly assigned subjects was required.
Differences between the randomized groups will be tested for statistical significance using the Pearson's Chi-Square test for categorical variables. For continuous variables, the independent t-test or Wilkoxon rank-sum test for independent samples will be used for not normally distributed variables. Both intention-to-test (ITT) and per-protocol (PP) analyses will be performed. The median operative time to complete wound closure was also estimated using the Kaplan-Meier method. A P-value < 0.05 is considered statistically significant. All statistical analyses are performed using SPSS for Windows, version 12.0 (SPSS, Inc, Chicago, IL).
- Conditions
- Scar Quality Assessment and Safety
- Being tested
- multi-layer wound closure
- Keywords
- Scar quality, Safety, Suture, Tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-layer wound closureProcedure or surgery
We prospectively analyze clinical outcome data from 30 subjects who perform multi-layer wound closure using polyglactin 910 and polypropylene, and polydioxanone and combination of 2-octyl cyanoacrylate and polyester mesh following excision of giant benign tumors.
| Study group | Role | What they receive |
|---|---|---|
| Vicryl+Prolene | Placebo comparator | wound closure using polyglactin 910 (Vicryl®, Ethicon, Johnson and Johnson Ltd., NJ, USA) and polypropylene (Prolene®, Ethicon) Receives: Procedure: multi-layer wound closure |
| PDS+Dermabond | Active comparator | wound closure using polydioxanone (StratafixTM Spiral PDS® Plus) and combination of 2-octyl cyanoacrylate and polyester mesh (Dermabond Prineo®) Receives: Procedure: multi-layer wound closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Patient and Observer Scar Assessment Scale (POSAS)
aesthetic outcome as assessed by the overall impression
Measured: six months
Secondary outcomes (1)
the Patient and Observer Scar Assessment Scale (POSAS)
aesthetic outcome as assessed by the overall impression
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start5 Feb 2022 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scar Quality Assessment and SafetyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Medical Korea Ltd
- Responsible party
- Principal investigator, Moon, Kyung Chul, Korea University Guro Hospital
- Investigators
- Kyung-Chul Moon, MD, PhD, Principal investigator, ICJME
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240820
- Sponsor's protocol ID
- WC-2020-09
- Status last verified
- Feb 2022
- First submitted
- 5 Feb 2022
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Associated With the Use of Polyglactin 910 (Vicryl®) and Polypropylene (Prolene®) Suture, and Polydioxanone (StratafixTM Spiral PDS® Plus) and Combination of 2-Octyl Cyanoacrylate and Polyester Mesh (Dermabond Prineo®) for Multi-Layer Wound Closure Following Excision of Giant Benign Tumors
- ClinicalTrials.gov ID
- NCT05240820
- Acronym / sponsor ID
- WC-2020-09
- Conditions
- Scar Quality Assessment and Safety
- Keywords
- Scar quality, Safety, Suture, Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Johnson & Johnson Medical Korea Ltd
- Study start
- 5 Feb 2022 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 15 Feb 2022 (actual)
- 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.
Due to the rise in the incidence of giant benign tumors such as lipoma, excision of benign tumors on body have been performed by plastic surgeons. After excision of giant benign tumors, efforts should be include with a goal of achieving optimal cosmetic outcomes after subcutaneous and dermal sutures may be important to improve scar quality because suture methods might influence the final aesthetic outcome. Various absorbable suture materials have been used for tension-relieving deep sutures. Subcutaneous and dermal sutures using Polygalctin 910 (Vicryl®, Ethicon, Johnson and Johnson Ltd.), which is absorbable, synthetic, braided suture composed of a copolymer made from 90% glycolide and 10% L-lactide or polydioxanone (PDS®, Ethicon), which is composed of polyester and p-dioxanone with skin suture using polypropylene (Prolene®, Ethicon) have been commonly used after excision of tumors.
Although these sutures are particularly useful where combination of absorbable suture and extended wound support for up to six weeks is desirable, strong and secure skin sutures may be needed to improve scar quality following excision of tumors on back and abdomen due to their thick skins. However, increased wound closure times are their drawbacks. To overcome these drawbacks, a new subcutaneous suture material composed of polydioxanone, StratafixTM Spiral PDS II® and a new skin suture material using combination of 2-octyl cyanoacrylate and polyester mesh (Dermabond Prineo®, Ethicon) have been developed and skin sutures using combination of these two materials may be an alternative suture method to decrease wound closure times and improve scar quality for better wound closure with high-tension closure, favorable and encouraging results compared to traditional suture methods.
Although polyglactin 910, polydioxanone, polypropylene, and combination of 2-octyl cyanoacrylate and polyester mesh have been used in general surgery and neurosurgery, no studies on the clinical outcomes, specifically on scar quality after excision of tumors have been reported in plastic surgery. Therefore, the purpose of this study is to compare clinical outcomes associated with scar quality between the use of polyglactin 910 and polypropylene suture, and polydioxanone and combination of 2-octyl cyanoacrylate and polyester mesh for multi-layer wound closure following excision of giant benign tumors.
Detailed description
We prospectively analyze clinical outcome data from 30 subjects who perform multi-layer wound closure using polyglactin 910 (Vicryl®, Ethicon, Johnson and Johnson Ltd., NJ, USA) and polypropylene (Prolene®, Ethicon), and polydioxanone (StratafixTM Spiral PDS® Plus) and combination of 2-octyl cyanoacrylate and polyester mesh (Dermabond Prineo®) following excision of giant benign tumors. Patients are randomized into two groups: one sutured by polyglactin 910 and polypropylene and the other group sutured by polydioxanone and combination of 2-octyl cyanoacrylate and polyester mesh. For a group sutured by polyglactin 910 and polypropylene, deep dermal layer will be sutured by polyglactin 910 and polypropylene will be used for suture of superficial dermis and epidermis. For the other group sutured by polydioxanone and combination of 2-octyl cyanoacrylate and polyester mesh, deep dermal layer will be sutured by polydioxanone and polyester mesh will be applied for approximation of superficial dermal layer and epidermis.
A computer-generated list, created using random permuted blocks of 6, that is stratified by hospital will be used for randomization. The allocation configuration will be generated and concealed until interventions will be assigned by a secretary not involved in this trial. Patients with benign tumors greater than 20cm2 (expected scar length more than 3cm) will be included in this study. A Sonography or magnetic resonance imaging scan with millimeter slices will be performed to measure the size of the tumors.
Based on previous studies, the number of subjects was calculated in this study. The weighted scar quality was 2.85 ± 0.57 in one group and 1.96 ± 0.58 in the other group. The following values were used to calculate the number of subjects: Type I error (α) = 5%, power of test = 95%. Independent t-test was used to calculate sample size and differences between two independent means of two groups were used for calculation of sample size. Actual power was 0.954 and the calculation result of the sample size in each group was 10. Considering a drop-out rate of broadly 30%, the number of subjects in each group was 14.3 (=10/(1-0.30)) and a sample size of 30 (=15 × 2) randomly assigned subjects was required.
Differences between the randomized groups will be tested for statistical significance using the Pearson's Chi-Square test for categorical variables. For continuous variables, the independent t-test or Wilkoxon rank-sum test for independent samples will be used for not normally distributed variables. Both intention-to-test (ITT) and per-protocol (PP) analyses will be performed. The median operative time to complete wound closure was also estimated using the Kaplan-Meier method. A P-value < 0.05 is considered statistically significant. All statistical analyses are performed using SPSS for Windows, version 12.0 (SPSS, Inc, Chicago, IL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vicryl+Prolene | Placebo comparator | Procedure: multi-layer wound closurewound closure using polyglactin 910 (Vicryl®, Ethicon, Johnson and Johnson Ltd., NJ, USA) and polypropylene (Prolene®, Ethicon) |
| PDS+Dermabond | Active comparator | Procedure: multi-layer wound closurewound closure using polydioxanone (StratafixTM Spiral PDS® Plus) and combination of 2-octyl cyanoacrylate and polyester mesh (Dermabond Prineo®) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with benign tumors greater than 20cm2
- Patients with expected scar length (incision length) longer than 3cm
- Patients who need excision of benign tumors
Key exclusion criteria (2 listed)
- Pregnancy, lactation, patients with previous scars around the benign tumors
- Patients with wound infection, human immunodeficiency virus positive
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 |
|---|---|---|
| multi-layer wound closureWe prospectively analyze clinical outcome data from 30 subjects who perform multi-layer wound closure using polyglactin 910 and polypropylene, and polydioxanone and combination of 2-octyl cyanoacrylate and polyester mesh following excision of giant benign tumors. | Procedure or surgery | PDS+Dermabond, Vicryl+Prolene |
Primary outcome
the Patient and Observer Scar Assessment Scale (POSAS)
Time frame: six months
aesthetic outcome as assessed by the overall impression
1 secondary outcome
the Patient and Observer Scar Assessment Scale (POSAS)
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No
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RecruitingPhase 1/2
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Scar Conditions and Fibrosis of Skin, Scar Quality Assessment and Safety
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.
Kyung-Chul Moon, MD, PhD principal investigator
ICJME
Questions about this trial
What is this clinical trial studying?
A study testing multi-layer wound closure in people with Scar Quality Assessment and Safety, run by Korea University Guro Hospital.
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 2 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 15 Feb 2022. 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. Some participants in this study may receive a placebo. 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?
Contact Kyung-Chul Moon, MD, PhD (821053403882, boyhaha2000@daum.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Patient and Observer Scar Assessment Scale (POSAS) (time frame: six 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 15 Feb 2022.