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Scar PreventionNCT06312527

Mepiform in Simultaneous Bilateral TKA

A study testing Silicone dressing in people with Scar Prevention, run by Thammasat University Hospital at 1 site in Thailand.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Scar Prevention
What is being tested?
Silicone dressing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteThailand
Study dates
7 Mar 2024to 31 May 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • The participants had previous knee surgery
  • The participants have had a scar on the knee before getting the surgery. 3. Periprosthetic joint infection.
  • 4. 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)

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Thammasat University

    Khlong Luang, Changwat Pathum Thani, 12120

Other trials in Thailand

About this study

Official title: Efficacy of a Soft Silicone Dressing to Prevent Scarring After Bilateral Total Knee Arthroplasty: A Randomized Paired Controlled Trial.

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.
Read the detailed description
  1. After the patient has passed the above selection criteria A team of non-surgery investigators will now describe the program in detail, the benefits and risks of the program. If the patient voluntarily agrees to participate in the program. The patient will sign the statement in writing and they can ask questions. The patients had to pass the selection criteria and be excluded from the research.
  2. Record personal information about the patient\'s surgery, including age, sex, weight, height, knee deformities and knee severity before surgery. History of scar formation on the body (hypertrophic scar or keloid)
  3. The range of motion of the knee before surgery was assessed by physical examination by using the Goniometer by the research assistant and assessing the knee functional ability score. Using the Forgotten joint score and Modified WOMAC score assessment form.
  4. Joint replacement surgery for both knees using the same type of prosthetic knee. After the surgery, the wound was sutured by a joint reconstructive fellowship by sewing all 3 layers consisting of the first layer is sutured with vicryl 1/0 threads, with the upper half of the knee above the center of the patella sutured (interrupt suture), and the lower half sutured continuously (continuous locking suture). The second layer is sutured under the skin(subcutaneous suture) by stitching. The tissues are brought close together using Vicryl 1/0 threads and continuous concealed cosmetic suture using 3rd layer of Vicryl 2/0 threads. Skin closure using Monosyn 4/0 threads and covered with Leukostrip sticky tape, after which the wound was covered with an Opsite Dressing. All patient will be recommend the same standard care after discharge. Wound will be cover the with an Opsite dressing and if there leakage or water into the wound. A dry dressing is recommended, followed by an Opsite dressing.
  5. Take care after surgery by giving pain medication. The standard postoperative physical therapy was the same in all patients
  6. Follow-up at approximately 2 weeks after surgery. After the wound has been opened and the tape has been removed. The surgeon evaluates the wound after surgery. If there are no complications of the surgical wound. The envelope will be opened according to the researcher\'s number. which is randomly generated using a computer to see which side will receive a silicone sheet dressing (soft-silicone dressing, Mepiform®, Mölnlycke Health Care AB, Gothenburg, Sweden), which side does not require closure. To care for the wound after 2 weeks, the wound can be cleaned with water or soap like normal skin on both sides.
  7. The patient was allowed range of motion exercise and knee motion were recorded.
  8. The patient will be taught how to use the silicone sheet. By covering the entire surgical wound at least 1 cm and closing it in the knee bend approximately 30 degrees, the wound must be closed 24 hours a day by taking it out when taking a shower 1-2 times a day, changing the dressing sheet every 7 days by Close the silicone cover for 10 weeks. As a study by Thomas A, et al9 recommends covering the wound dressing to prevent postoperative scarring. At least for a period of 2 months, errors will be controlled with a silicone sheet closure instruction sheet for all patients. including identifying the side that covers the silicone sheet.
  9. Appointment for follow-up treatment of patients after surgery Follow-up assessments will be made at approximately 6 weeks, 3 months, 6 months and 1 year after surgery. The research assistant measured the flexion range of the knee joint and assessing the function of the knee joint. The scar will be assessed by a dermatologist which will not know which side will be the side that has been using the silicone cover throughout the evaluation. Including the evaluation of wound complications such as split wounds, thrombosis around the surgical wound, Abscesses due to stitch abscess and other complications such as Deep vein thrombosis. If such complications, Research participants will be excluded from the study and will receive standard treatment by the research physicians team.
Conditions
Scar Prevention
Being tested
Silicone dressing
Keywords
Scar prevention, total knee arthroplasty, Silicone dressing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Silicone dressingDevice

    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.

Study groups in NCT06312527
Study groupRoleWhat they receive
Silicone dressingExperimentalApply silicone dressing after wound completely healed. Changing the dressing sheet every 7 days by Close the silicone cover for 10 weeks.
Receives: Device: Silicone dressing
No interventionNo interventionDo not apply silicone dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vancouver Scar Scale

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

    Measured: 6week, 3month, 6month, 1 year

Secondary outcomes (6)

  1. Range of motion

    evaluate by long arm goniometer (degree)

    Measured: 6week, 3month, 6month, 1 year

  2. Forgotten joint score

    Forgotten joint score (point) (range 0-100, 0 mean worst, 100 mean best)

    Measured: 6week, 3month, 6month, 1year

  3. modified WOMAC score

    modified WOMAC score (point) (range 0-96, 0 mean best, 96 mean worst)

    Measured: 6week, 3month, 6month, 1year

  4. Scar pain

    evaluate by visual analog scale (point) (0-10, 0 mean best, 10 mean worst)

    Measured: 6week, 3month, 6month, 1year

  5. Scar itching

    evaluate by visual analog scale (point) (0-10, 0 mean best, 10 mean worst)

    Measured: 6week, 3month, 6month, 1year

  6. Complications

    Wound complication ex deep joint infection, surgical site infection, wound dehiscence

    Measured: 6week, 3month, 6month, 1year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start7 Mar 2024
  3. Primary completion31 May 2024
  4. Study completion31 May 2025 (estimated)

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06312527
Sponsor's protocol ID
TUH Mepiform TKA
Status last verified
Apr 2025
First submitted
7 Mar 2024
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24509938

Questions about this trial

What is this clinical trial studying?

A study testing Silicone dressing in people with Scar Prevention, run by Thammasat University Hospital at 1 site in Thailand.

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 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

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?

Vancouver Scar Scale (time frame: 6week, 3month, 6month, 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06312527, which also lists 1 linked publication.

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 9 Apr 2025.

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