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

Surgical Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04928443
• Other study ID #: 202100112B0A3
• Status: Not yet recruiting
• Start date: August 15, 2021
• Est. completion date: June 20, 2022

Study information

• Verified date: June 2021
• Source: Chang Gung Memorial Hospital
• Contact: Chia-Hsieh Chang, Prof.
• Phone: 886-33281200
• Email: chiahchang[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 20, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix
• Surgical Scar

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Scar Assessment Scale	In scar dressing group, patient scar assessment scale consists of 6 questions. Each question is rated from 1 to 10. 1 is the best and 10 reflects the worst.	From surgical wound healed to 6 months later
Secondary	Incidence of incision site complication	Percentage of the population suffering from surgical scar-related complications are analyzed, especially the ones toward scar dressing.	From surgical wound healed to 6 months later
Secondary	Patient satisfaction	In scar dressing group, patients are asked with serial questions to rate satisfaction toward scar dressing on a numeric rating scale. 1 means the most unsatisfaction and 10 means the most satisfaction.	3 months after surgical wound healing