- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07645664
Scar Management Through Serial Casting
9. juni 2026 oppdatert 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
38
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jakub Sawicki, MSc
- Telefonnummer: 4229 514-288-8201
- E-post: jakub.sawicki.chum@ssss.gouv.qc.ca
Studer Kontakt Backup
- Navn: Geneviève Schneider, MSc, OT
- Telefonnummer: 514-288-8201
- E-post: genevieve.schneider.vmed@ssss.gouv.qc.ca
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Ingen inngripen: Control scar
No intervention, standard of care only.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Skin Thickness Changes
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjective Scar Satisfaction Level
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Bernadette Nedelec, PhD, OT(c), Centre hospitalier de l'Université de Montréal (CHUM)
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
1. november 2028
Studiet fullført (Antatt)
1. november 2028
Datoer for studieregistrering
Først innsendt
9. juni 2026
Først innsendt som oppfylte QC-kriteriene
9. juni 2026
Først lagt ut (Faktiske)
12. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2027-13669
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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