The Management of Surgical Scars Around Knee After Pediatric Orthopedic Surgery: an Observational, Case-control Study

NCT ID: NCT04928443

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-15
• Study Completion Date: 2022-06-20

Brief Summary

Scar is an unpleasant symptom that commonly appear after orthopedic surgery, especially the joint procedure. Due to the wide motion range, skin around joint has excessive tension that may increase risk for wide or conspicuous scar formation of surgical wound. Noticeable scar can negatively impact the quality of life and psychosocial development. However, scar management is overlooked in early recovery period easily. Patients commonly start to turn their attention to the surgical scar after the completion of rehabilitation or the resolution of disease or unbearable symptom. It is always beyond the best period of scar treatment, 3 to 6 months after wound healing. This study is aimed to observe and evaluate the scar formation with or without aggressive management in pediatric population within 6 months after wound healing.

Detailed Description

This is an observational, case-control study. Patients will be invited to participate and allocated to scar dressing group if they plan to use scar dressing. After gaining the written inform consent, participants will be asked to fulfill the patient diary, including the record of scar dressing use, patient scar assessment scale and satisfaction assessment, with parents' help. In regular group, patients are retrospectively selected by matched factors, such as demographics data. Scar-related data, including scar pictures, vancouver scar scale assessment and complication, are collected from medical history in both groups.

Conditions

Surgical Scar

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Scar dressing group

Patients planning to treat surgical scar with scar dressing

Scar dressing group

Intervention Type: OTHER

Patients treated with scar dressing for surgical scar care are invited to participate this study and allocated in scar dressing group despite the length of caring period.

Regular care group

Patients treated with adhesive tapes or strips or did not take care of surgical scar.

Regular care group

Intervention Type: OTHER

Patients receiving regular scar care are retrospectively identified with matching factors, such as gender, age, length of surgical wound and surgical procedure.

Interventions

Scar dressing group

Patients treated with scar dressing for surgical scar care are invited to participate this study and allocated in scar dressing group despite the length of caring period.

Intervention Type: OTHER

Regular care group

Patients receiving regular scar care are retrospectively identified with matching factors, such as gender, age, length of surgical wound and surgical procedure.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Aged 5 to 18 years

2. Had orthopedic surgery 3 weeks ago and within 6 weeks

3. Had incision sites around the knee

4. All surgical wounds healed completely

5. Length of surgical wounds between 2 and 15 centimeters

6. Planed to treat incisional scar with scar dressing, adhesive tapes, or adhesive strips

Exclusion Criteria

1. Surgical wound infection

2. Atopic dermatitis or sensitive skin

3. Not able to make return visits regularly

4. Participation was not appropriate determined by physician

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chia-Hsieh Chang, Prof.

Role: STUDY_CHAIR

Chang Gung Medical Foundation

Central Contacts

Chia-Hsieh Chang, Prof.

Role: CONTACT

chiahchang@gmail.com

886-33281200 ext. 3328

Other Identifiers

202100112B0A3

Identifier Type: -

Identifier Source: org_study_id