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Development and Clinical Study of Burn Wound Nursing Dressing Based on Sodium Hyaluronate Carbomer Composite Hydrogel

28. april 2026 opdateret af: The First Affiliated Hospital of Xinxiang Medical College

Development and Preclinical Study of Nursing Dressing for Ⅰ/Shallow Ⅱ Degree Burn Wounds Based on Sodium Hyaluronate Carbomer Composite Hydrogel

Development and clinical study of burn wound nursing dressing based on sodium hyaluronate carbomer composite hydrogel

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Development and preclinical study of nursing dressing for Ⅰ/shallow Ⅱ degree burn wounds based on sodium hyaluronate carbomer composite hydrogel

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

Partial or full thickness burns requiring split thickness skin grafts Target burn wound size between 10 cm² and 1000 cm² Age ≥ 18 years Ability to read, write, and speak German Provision of voluntary informed consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations Informed consent will be obtained from the patient or from a legal representative if the patient is not able or competent to consent; in such cases, informed consent will also be obtained from the patient when he/she regains competence Women of childbearing potential must test negative on a standard urine pregnancy test and must agree to practice appropriate contraceptive methods for the duration of the study (e.g., oral contraceptive, intrauterine device [IUD], intramuscular contraceptive, abstinence)

Exclusion Criteria:

Target wound has exposed hyaline cartilage Connective tissue disorder Previous skin graft failure at target wound site Total burn surface area ≥ 70% Infected target wound Immunosuppression therapy Chronic hemodialysis Steroid use Diabetes (Type I) Allergy or sensitivity to any of the ingredients in Prontosan® Wound Gel X Allergy or sensitivity to chlorhexidine Pregnancy Simultaneous participation in another clinical trial

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: sodium hyaluronate carbomer composite hydrogel
Kombinationsprodukt: sodium hyaluronate carbomer composite hydrogel
Development and preclinical study of nursing dressing for Ⅰ/shallow Ⅱ degree burn wounds based on sodium hyaluronate carbomer composite hydrogel

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Graft neo-epithelisation
Tidsramme: 50 days. Metric for Summarizing Data: Number and percentage of participants achieving complete neo-epithelisation by Day 50 Mean (±SD) and median (IQR) time to complete neo-epithelisation Rate of neo-epithelisation (% wound closure per day)
Complete neo-epithelisation is defined as 100% coverage of the grafted burn wound area by new epithelial tissue without any residual open wound, as determined by two independent blinded assessors using standardized clinical photography combined with digital planimetry software (ImageJ or equivalent). Wound images will be captured at baseline (Day 0) and at each follow-up visit (Days 7, 14, 21, 28, 35, 42, 50) using a standardized photography protocol (fixed camera distance, lighting, and anatomical reference markers). The percentage of wound area achieving complete neo-epithelisation will be calculated as: (area of neo-epithelialized tissue / total initial wound area) × 100%. The primary endpoint is the proportion of participants achieving complete neo-epithelisation by Day 50.
50 days. Metric for Summarizing Data: Number and percentage of participants achieving complete neo-epithelisation by Day 50 Mean (±SD) and median (IQR) time to complete neo-epithelisation Rate of neo-epithelisation (% wound closure per day)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pruritis
Tidsramme: 50 days. Metric for Summarizing Data: Mean (±SD) change from baseline in NRS score at Day 50 Median (IQR) change from baseline Number and percentage of participants with ≥ 4-point reduction or NRS ≤ 3 Median time to pruritus relief AUC of NRS scores
Pruritus (itching) severity will be assessed using the Numerical Rating Scale (NRS), a validated self-reported scale where participants rate their worst itching intensity over the past 24 hours on an 11-point scale ranging from 0 (no itching) to 10 (worst imaginable itching). Participants will complete the NRS assessment daily from Day 0 (baseline, prior to dressing application) through Day 50. The primary metric for this outcome is the mean change from baseline in NRS score at Day 50. Secondary metrics include: (1) the proportion of participants achieving a clinically meaningful reduction in pruritus (defined as ≥ 4-point decrease from baseline or NRS score ≤ 3); (2) time to onset of pruritus relief (first day with ≥ 2-point decrease maintained for ≥ 3 consecutive days); and (3) area under the curve (AUC) of NRS scores over the 50-day study period. Higher scores indicate worse pruritus severity.
50 days. Metric for Summarizing Data: Mean (±SD) change from baseline in NRS score at Day 50 Median (IQR) change from baseline Number and percentage of participants with ≥ 4-point reduction or NRS ≤ 3 Median time to pruritus relief AUC of NRS scores

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The First Affiliated Hospital of Xinxiang Medical College

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. august 2026

Primær færdiggørelse (Anslået)

20. december 2027

Studieafslutning (Anslået)

20. oktober 2028

Datoer for studieregistrering

Først indsendt

8. april 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BS-2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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