A Comparative Study of Scar Quality and Safety According to Suture Materials Following Excision of Benign Tumors

NCT ID: NCT05240820

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-05
• Study Completion Date: 2023-08-31

Brief 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 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).

Conditions

Scar Quality Assessment and Safety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vicryl+Prolene

wound closure using polyglactin 910 (Vicryl®, Ethicon, Johnson and Johnson Ltd., NJ, USA) and polypropylene (Prolene®, Ethicon)

Group Type: PLACEBO_COMPARATOR

multi-layer wound closure

Intervention Type: PROCEDURE

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.

PDS+Dermabond

wound closure using polydioxanone (StratafixTM Spiral PDS® Plus) and combination of 2-octyl cyanoacrylate and polyester mesh (Dermabond Prineo®)

Group Type: ACTIVE_COMPARATOR

multi-layer wound closure

Intervention Type: PROCEDURE

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.

Interventions

multi-layer wound closure

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with benign tumors greater than 20cm2
• Patients with expected scar length (incision length) longer than 3cm
• Patients who need excision of benign tumors

Exclusion Criteria

• Pregnancy, lactation, patients with previous scars around the benign tumors
• Patients with wound infection, human immunodeficiency virus positive

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson and Johnson Medical Korea Ltd

UNKNOWN

Sponsor Role: collaborator

Korea University Guro Hospital

OTHER

Sponsor Role: lead

Responsible Party

Moon, Kyung Chul

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyung-Chul Moon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ICJME

Central Contacts

Kyung-Chul Moon, MD, PhD

Role: CONTACT

boyhaha2000@daum.net

821053403882

Other Identifiers

WC-2020-09

Identifier Type: -

Identifier Source: org_study_id