Clinical trial NCT04928443: The Management of Surgical Scars Around Knee After Pediatric Orthopedic Surgery: an Observational, Case-control Study
Official title: The Management of Surgical Scars Around Knee After Pediatric Orthopedic Surgery: an Observational, Case-control Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Scar
Keywords: Scar-care
Surgical wound
Incision site
Cicatrix
Fibrosis
Knee
Pediatric
Orthopedic Procedures
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Vancouver Scar Scale
timeFrame: 3 months after surgical wound healing
Secondary outcomes:
measure: Patient Scar Assessment Scale
timeFrame: From surgical wound healed to 6 months later
measure: Incidence of incision site complication
timeFrame: From surgical wound healed to 6 months later
measure: Patient satisfaction
timeFrame: 3 months after surgical wound healing
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Medical Foundation
name: Chia-Hsieh Chang, Prof.
role: STUDY_CHAIR
References: