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NCT Number: NCT07645664

Scar Management Through Serial Casting

Scar management remains one of the major clinical challenges for burn survivors with hypertrophic scars. Beyond their visible appearance, hypertrophic scars can significantly impair physical function, reduce life satisfaction, and affect overall quality of life. According to the results of a recently completed study, the application of serial casts appears promising for the treatment of hypertrophic scars in adults who have survived a burn injury. However, this therapeutic approach has not yet been evaluated objectively in terms of scar characteristics within the context of a study with sufficient statistical power. The present project is the first study with sufficient statistical power to objectively evaluate the beneficial effects of serial casting on the characteristics of hypertrophic scars in adult burn survivors. The objective of this study is to characterize changes in thickness, elasticity, vascularization, transepidermal water loss (TEWL), itching, and pain in hypertrophic burn scars in adults after one week of treatment with serial dressings, compared to an intra-individual control scar. Our hypothesis is that relative to baseline measures the scar thickness (primary outcome), erythema index, TEWL, itch, and pain will decrease at treatment sites compared to control sites. Conversely, elasticity will increase at the treatment sites compared to control sites. This will be a prospective, longitudinal, evaluator-blinded, randomized intra-individual controlled trial.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This will be a prospective, longitudinal, evaluator-blinded, randomized intra-individual controlled trial. Participants will start serial casting on selected scars during 7 days for 24 hrs/day. The objective scar characteristics and the subjective scar quality appreciation level will be evaluated immediately before and immediately after serial casting, and then 3 weeks after the cast has been removed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult burn survivors who have two scars that meet the diagnostic criteria of a HSc (erythema index greater than 300 and thickness greater than 2.034 mm) and with no more than 0.5 mm thickness difference between each other;
  • are proficient in English and/or French;
  • provide informed consent.

Exclusion criteria

  • patients who sustained electrical or cold injury;
  • formed keloid scars or have only mature scars (erythema index less than 300);
  • have a a dermatological condition that could interfere with measurement reliability (eczema, psoriasis);
  • have a cognitive/psychiatric condition that could impaired understanding of the consent process or adherence to protocol procedures.

Treatment and study plan

Serial casted scar

Other

At the preselected treatment site, a serial cast will be applied by a trained OT and worn by participant for 7 days.

Primary outcomes

  1. Skin Thickness Changes

    Time frame: right before intervention, right after intervention, three weeks after intervention

    Ultrasound skin thickness (mm) measured by Dermascan

Secondary outcomes

  1. Subjective Scar Satisfaction Level

    Time frame: right before intervention, right after intervention, three weeks after intervention

    Subjective Scar Satisfaction Level evaluated by POSAS (Patient and Observer Scar Assessment Scale) v. 2.0 modified; visual analog scale (score 0-identical to- 10-very different from normal skin).

  2. Skin Erythema Changes

    Time frame: right before intervention, right after intervention, three weeks after intervention

    Erythema index measure by Mexameter, values from 0 to 999. The erythema values are individual for each person and depend strongly on the skin type. The measurements are generally used to determine changes before and after a treatment.

  3. Trans-epidermal water loss (TEWL)

    Time frame: right before intervention, right after intervention, three weeks after intervention

    Trans-epidermal water loss (TEWL) measured by Tewameter.

  4. Skin Melanin Changes

    Time frame: right before intervention, right after intervention, three weeks after intervention

    Melanin index measured by Mexameter

  5. Skin Elasticity Changes

    Time frame: right before intervention, right after intervention, three weeks after intervention

    Skin elasticity measures (mm) measured by Cutometer (r0)

Study contacts

Contact information is provided by the study sponsor or research team.

Geneviève Schneider, MSc, OT

CONTACT

[email protected]

514-288-8201

Jakub Sawicki, MSc

CONTACT

[email protected]

514-288-8201 ext. 4229

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Hôpital de réadaptation Villa Medica, Montreal

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

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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