Mepiform in Simultaneous Bilateral TKA

NCT06312527 | Active Not Recruiting DMC

• 1 other identifier: TUH Mepiform TKA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this RCT is comparing efficacy of silicone dressing in scar preventing after simultaneous bilateral total knee arthroplasty. The main question\[s\] it aims to answer are:

• Does silicone dressing can prevent scar formation after total knee arthroplasty?
• Does silicone dressing have similar functional outcomes and complications after total knee arthroplasty? Participants will apply silicone dressing after wound healed and apply for 10 weeks. Researchers will compare to the other side that is no intervention.

Conditions

Scar Prevention

Keywords

Scar prevention; total knee arthroplasty; Silicone dressing

Outcome Measures

Primary Outcomes (1)

• Vancouver Scar Scale

  Vancouver Scar Scale evaluate by dermatologist (point) Range from 0-13 (0 mean best, 13 mean worst)

  6week, 3month, 6month, 1 year

Secondary Outcomes (6)

• Range of motion

  6week, 3month, 6month, 1 year

• Forgotten joint score

  6week, 3month, 6month, 1year

• modified WOMAC score

  6week, 3month, 6month, 1year

• Scar pain

  6week, 3month, 6month, 1year

• Scar itching

  6week, 3month, 6month, 1year

Study Arms (2)

Silicone dressing

EXPERIMENTAL

Apply silicone dressing after wound completely healed. Changing the dressing sheet every 7 days by Close the silicone cover for 10 weeks.

Device: Silicone dressing

No intervention

NO INTERVENTION

Do not apply silicone dressing

Interventions

Silicone dressing DEVICE

Participant will apply silicone dressing at 2 weeks after TKA on one side of knee. Silicone dressing will change every week until 12 week postoperative.

Silicone dressing

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 50-80 years
• The participant who undergo simultaneous bilateral total knee arthroplasty.
• The participant can understand and give consent to participate in the project.

You may not qualify if:

• The participants had previous knee surgery
• The participants have had a scar on the knee before getting the surgery. 3. Periprosthetic joint infection.
• \. There are other complications of the surgical wound, such as split wound, thrombosis around the surgical wound. Abscess caused by stitches (stitch abscess) 5. Deep vein thrombosis (DVT)

Sponsors & Collaborators

• Thammasat University Hospital: lead

Study Sites (1)

Thammasat University

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location

Related Publications (1)

• Kong CG, Kim GH, Kim DW, In Y. The effect of topical scar treatment on postoperative scar pain and pruritus after total knee arthroplasty. Arch Orthop Trauma Surg. 2014 Apr;134(4):555-9. doi: 10.1007/s00402-014-1942-7. Epub 2014 Feb 9.

  PMID: 24509938 BACKGROUND

Study Officials

• Yot Tanariyakul, M.D.

  Department of orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: March 7, 2024
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)