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Active, Not Recruiting

NCT Number: NCT06940999

An Innovative Image-Based Method for Extensibility Assessment

This study uses a mixed-method design combining a quasi-experimental, single-group pre-post intervention with a methodological validation approach.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypertrophic Scar Cicatrix Cicatrix, Hypertrophic Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaimaa Mohamed Ahmed Elsayeh

Cairo, New Cairo, 02, Egypt

About this study

  • Quasi-experimental, single-group pre-post intervention:

Participants will receive a standardized physical therapy protocol targeting scar contracture. After intervention, scar extensibility will be measured using traditional tools (Vancouver Scar Scale, tonometer) and a newly developed image-based method.

  • Methodological validation approach: The image-based method will be tested for:
  • Reliability (test-retest, inter-rater)
  • Validity (concurrent validity against established tools and construct validity)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of clinically diagnosed scar contracture following thermal burns.
  • Presence of scars (≥6 months post-burn) to ensure stability for accurate assessment.
  • Scars located on functionally mobile areas (e.g., limbs) where extensibility impacts daily activities.
  • Willingness to undergo a standardized physical therapy intervention.
  • Ability to provide informed consent and comply with all study procedures.

Exclusion criteria

  • Active infection, unhealed wounds, or unstable scars at the assessment site.
  • Diagnosed systemic diseases affecting collagen synthesis or wound healing (e.g., scleroderma, uncontrolled diabetes).
  • History of experimental or non-standard scar treatment within the last 3 months.
  • Severe cognitive impairments or communication barriers that interfere with understanding or participation.
  • Pregnant or lactating women, due to hormonal influences on tissue healing and collagen metabolism.
  • Concurrent participation in other physical therapy or rehabilitation studies targeting scar management.

Treatment and study plan

Traditional Physical therapy

Other

Application of laser three times per week in addition to applying deep friction massage, stretching exercises along with the uses of pressure garment.

Primary outcomes

  1. Vancouver Scar Scale (VSS)

    Time frame: Baseline and three months after the intervention

    to evaluate vascularity, pigmentation, pliability, and scar height.

  2. Firmness and pliability at the scar site

    Time frame: Baseline and three months after the intervention

    Tonometry will be used to assess tissue firmness and pliability at the scar site.

  3. Proposed Image-Based Method

    Time frame: Baseline and three months after the intervention

    the scar images before and after the intervention will go through three steps:

    • Image Acquisition: High-resolution digital images of scars will be captured using a standardized protocol (fixed camera settings, lighting, distance).
    • Image Preprocessing: Images will be converted to grayscale, and regions of interest (ROI) manually or automatically defined.
    • Image Analysis: The standard deviation (STD) of pixel intensities within the ROI will be calculated as an indicator of tissue extensibility and collagen fiber cross-linking patterns will be detected and quantified using advanced image processing algorithms.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Revolutionizing Scar Evaluation: An Innovative Image-Based Method for Extensibility Assessment

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 23, 2025
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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