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

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04928443

Collaborator

(none)

Enrollment

10.2

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Scar	Other: Scar dressing group Other: Regular care group

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 15, 2021

Anticipated Primary Completion Date :

Dec 20, 2021

Anticipated Study Completion Date :

Jun 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Scar dressing group Patients planning to treat surgical scar with scar dressing	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 treated with adhesive tapes or strips or did not take care of surgical scar.	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.

Arm

Intervention/Treatment

Scar dressing group

Patients planning to treat surgical scar with scar dressing

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

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.

Outcome Measures

Primary Outcome Measures

Vancouver Scar Scale [3 months after surgical wound healing]
Vancouver scar scale includes four items toward evaluation of observable aspects of the scar. Each item is rated with 4-6 possible points.

Secondary Outcome Measures

Patient Scar Assessment Scale [From surgical wound healed to 6 months later]
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.
Incidence of incision site complication [From surgical wound healed to 6 months later]
Percentage of the population suffering from surgical scar-related complications are analyzed, especially the ones toward scar dressing.
Patient satisfaction [3 months after surgical wound healing]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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