Surgical ScarNCT04928443
The Management of Surgical Scars Around Knee After Pediatric Orthopedic Surgery: an Observational, Case-control Study
An observational study of Surgical Scar, run by Chang Gung Memorial Hospital.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Surgical Scar
- What is being tested?
- Scar dressing group and Regular care group
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2021to 20 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- Surgical wound infection
- Atopic dermatitis or sensitive skin
- Not able to make return visits regularly
- Participation was not appropriate determined by physician
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Management of Surgical Scars Around Knee After Pediatric Orthopedic Surgery: an Observational, Case-control Study.
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.
Read the 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
- Being tested
- Scar dressing group, Regular care group
- Keywords
- Scar-care, Surgical wound, Incision site, Cicatrix, Fibrosis, Knee, Pediatric, Orthopedic Procedures
- Medical subject headings
- Surgical Wound, Cicatrix, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scar dressing groupOther
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 groupOther
Patients receiving regular scar care are retrospectively identified with matching factors, such as gender, age, length of surgical wound and surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Scar dressing group | Patients planning to treat surgical scar with scar dressing Receives: Other: Scar dressing group | |
| Regular care group | Patients treated with adhesive tapes or strips or did not take care of surgical scar. Receives: Other: Regular care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after surgical wound healing
Secondary outcomes (3)
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.
Measured: From surgical wound healed to 6 months later
Incidence of incision site complication
Percentage of the population suffering from surgical scar-related complications are analyzed, especially the ones toward scar dressing.
Measured: From surgical wound healed to 6 months later
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.
Measured: 3 months after surgical wound healing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start15 Aug 2021 (estimated)
- Primary completion20 Dec 2021 (estimated)
- Study completion20 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical ScarStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-Hsieh Chang, Prof., Study chair, Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928443
- Sponsor's protocol ID
- 202100112B0A3
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management of Surgical Scars Around Knee After Pediatric Orthopedic Surgery: an Observational, Case-control Study.
- ClinicalTrials.gov ID
- NCT04928443
- Acronym / sponsor ID
- 202100112B0A3
- Conditions
- Surgical Scar
- Keywords
- Scar-care, Surgical wound, Incision site, Cicatrix, Fibrosis, Knee, Pediatric, Orthopedic Procedures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Aug 2021 (estimated)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 20 Jun 2022 (estimated)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scar dressing group | – | Other: Scar dressing groupPatients planning to treat surgical scar with scar dressing |
| Regular care group | – | Other: Regular care groupPatients treated with adhesive tapes or strips or did not take care of surgical scar. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Surgical wound infection
- Atopic dermatitis or sensitive skin
- Not able to make return visits regularly
- Participation was not appropriate determined by physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scar dressing groupPatients 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. | Other | Scar dressing group |
| Regular care groupPatients receiving regular scar care are retrospectively identified with matching factors, such as gender, age, length of surgical wound and surgical procedure. | Other | Regular care group |
Primary outcome
Vancouver Scar Scale
Time frame: 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.
3 secondary outcomes
Patient Scar Assessment Scale
Time frame: From surgical wound healed to 6 months later
Incidence of incision site complication
Time frame: From surgical wound healed to 6 months later
Patient satisfaction
Time frame: 3 months after surgical wound healing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Hsieh Chang, Prof. study chair
Chang Gung Medical Foundation
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Scar, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Hsieh Chang, Prof. (886-33281200 ext. 3328, chiahchang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancouver Scar Scale (time frame: 3 months after surgical wound healing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.