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

August 4, 2021 updated by: Chang Gung Memorial Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months after surgical wound healing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Scar Assessment Scale
Time Frame: 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.
From surgical wound healed to 6 months later
Incidence of incision site complication
Time Frame: 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.
From surgical wound healed to 6 months later
Patient satisfaction
Time Frame: 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.
3 months after surgical wound healing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Chair: Chia-Hsieh Chang, Prof., Chang Gung Medical Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 15, 2021

Primary Completion (Anticipated)

December 20, 2021

Study Completion (Anticipated)

June 20, 2022

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202100112B0A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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