Scar Management Through Serial Casting
9 juni 2026 uppdaterad av: Bernadette Nedelec, Centre hospitalier de l'Université de Montréal (CHUM)
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
38
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Jakub Sawicki, MSc
- Telefonnummer: 4229 514-288-8201
- E-post: jakub.sawicki.chum@ssss.gouv.qc.ca
Studera Kontakt Backup
- Namn: Geneviève Schneider, MSc, OT
- Telefonnummer: 514-288-8201
- E-post: genevieve.schneider.vmed@ssss.gouv.qc.ca
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Treated scar
Serial casting treatment
|
At the preselected treatment site, a serial cast will be applied by a trained OT and worn by participant for 7 days.
|
|
Inget ingripande: Control scar
No intervention, standard of care only.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Skin Thickness Changes
Tidsram: right before intervention, right after intervention, three weeks after intervention
|
Ultrasound skin thickness (mm) measured by Dermascan
|
right before intervention, right after intervention, three weeks after intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Subjective Scar Satisfaction Level
Tidsram: 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).
|
right before intervention, right after intervention, three weeks after intervention
|
|
Skin Erythema Changes
Tidsram: 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.
|
right before intervention, right after intervention, three weeks after intervention
|
|
Trans-epidermal water loss (TEWL)
Tidsram: right before intervention, right after intervention, three weeks after intervention
|
Trans-epidermal water loss (TEWL) measured by Tewameter.
|
right before intervention, right after intervention, three weeks after intervention
|
|
Skin Melanin Changes
Tidsram: right before intervention, right after intervention, three weeks after intervention
|
Melanin index measured by Mexameter
|
right before intervention, right after intervention, three weeks after intervention
|
|
Skin Elasticity Changes
Tidsram: right before intervention, right after intervention, three weeks after intervention
|
Skin elasticity measures (mm) measured by Cutometer (r0)
|
right before intervention, right after intervention, three weeks after intervention
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Bernadette Nedelec, PhD, OT(c), Centre hospitalier de l'Université de Montréal (CHUM)
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
1 november 2028
Avslutad studie (Beräknad)
1 november 2028
Studieregistreringsdatum
Först inskickad
9 juni 2026
Först inskickad som uppfyllde QC-kriterierna
9 juni 2026
Första postat (Faktisk)
12 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2027-13669
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .