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

NCT05240820 | Unknown DMC

• 1 other identifier: WC-2020-09
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Scar Quality Assessment and Safety

Keywords

Scar quality; Safety; Suture; Tumor

Outcome Measures

Primary Outcomes (1)

• the Patient and Observer Scar Assessment Scale (POSAS)

  aesthetic outcome as assessed by the overall impression

  six months

Secondary Outcomes (1)

• the Patient and Observer Scar Assessment Scale (POSAS)

  three months

Other Outcomes (1)

• Postoperative complications

  six months

Study Arms (2)

Vicryl+Prolene

PLACEBO COMPARATOR

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

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®)

Procedure: multi-layer wound closure

Interventions

multi-layer wound closure 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; Vicryl+Prolene

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• Johnson and Johnson Medical Korea Ltd: collaborator

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kyung-Chul Moon, MD, PhD

  ICJME

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyung-Chul Moon, MD, PhD

CONTACT

821053403882; boyhaha2000@daum.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 15, 2022
• Study Start: February 5, 2022
• Primary Completion: February 28, 2023
• Study Completion: August 31, 2023
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share