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

NCT04928443 | Unknown

• 1 other identifier: 202100112B0A3
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgical Scar

Keywords

Scar-care; Surgical wound; Incision site; Cicatrix; Fibrosis; Knee; Pediatric; Orthopedic Procedures

Outcome Measures

Primary Outcomes (1)

• Vancouver Scar Scale

  Vancouver scar scale includes four items toward evaluation of observable aspects of the scar. Each item is rated with 4-6 possible points.

  3 months after surgical wound healing

Secondary Outcomes (3)

• Patient Scar Assessment Scale

  From surgical wound healed to 6 months later

• Incidence of incision site complication

  From surgical wound healed to 6 months later

• Patient satisfaction

  3 months after surgical wound healing

Study Arms (2)

Scar dressing group

Patients planning to treat surgical scar with scar dressing

Other: Scar dressing group

Regular care group

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

Other: Regular care group

Interventions

Scar dressing group 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.

Scar dressing group

Regular care group OTHER

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

Regular care group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

1. Patients 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. Planning to treat incisional scar with scar dressing, adhesive tapes, or adhesive strips

You may qualify if:

• Aged 5 to 18 years
• Had orthopedic surgery 3 weeks ago and within 6 weeks
• Had incision sites around the knee
• All surgical wounds healed completely
• Length of surgical wounds between 2 and 15 centimeters
• Planed to treat incisional scar with scar dressing, adhesive tapes, or adhesive strips

You may not qualify if:

• Surgical wound infection
• Atopic dermatitis or sensitive skin
• Not able to make return visits regularly
• Participation was not appropriate determined by physician

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Surgical Wound; Cicatrix; Fibrosis

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chia-Hsieh Chang, Prof.

  Chang Gung Medical Foundation

  STUDY CHAIR

Central Study Contacts

Chia-Hsieh Chang, Prof.

CONTACT

886-33281200; chiahchang@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 16, 2021
• Study Start: August 15, 2021
• Primary Completion: December 20, 2021
• Study Completion: June 20, 2022
• Last Updated: August 5, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share