- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07647458
Quantifying Adhesive Residue on Skin Following Removal of Maxillofacial Prosthetic Adhesives: An In Vivo Study (ARMS)
A Comparative Assessment of Adhesive Residue on the Skin Following the Removal of Extraoral Silicone Prosthesis: An In Vivo Study
Studieoversikt
Status
Forhold
Detaljert beskrivelse
This pilot interventional in vivo study is designed to quantitatively evaluate and compare the amount of adhesive residue left on the skin following removal of extraoral maxillofacial prosthetic adhesives. Adhesive-retained facial prostheses are widely used in maxillofacial rehabilitation; however, residual adhesive remaining on the skin after prosthesis removal may contribute to patient discomfort, skin irritation, and difficulty in daily prosthesis maintenance. Despite its clinical importance, adhesive residue has not been quantitatively evaluated in vivo.
Five commercially available maxillofacial prosthetic adhesives, including silicone-based and water-based formulations, will be evaluated using standardized silicone elastomer strips. Five healthy volunteers between 18 and 30 years of age will be recruited. Thirty test sites will be prepared on the volar surfaces of the forearms, with six sites allocated to each adhesive group through block randomization. Participants with skin diseases, adhesive allergies, systemic conditions affecting skin integrity, pregnancy, lactation, or recent skin injuries will be excluded.
Standardized silicone strips measuring 60 × 20 × 3 mm will be fabricated and coated with a uniform quantity of adhesive. After a drying period of 3 minutes, the strips will be applied to designated skin sites and maintained for 8 hours during normal daily activities. Following removal, the strips will be reweighed using a high-precision analytical balance. Adhesive residue remaining on the skin will be quantified using gravimetric analysis by calculating the percentage difference between initial and final strip weights.
The primary outcome measure is the percentage of adhesive residue remaining on the skin after removal of the prosthetic adhesive. Secondary objectives include assessment of adhesive failure modes and comparison of residue patterns between silicone-based and water-based adhesive systems.
To minimize bias, participant allocation sites will be randomized and both participants and investigators involved in application and evaluation procedures will remain blinded to adhesive identity. Statistical analysis will be performed using one-way analysis of variance followed by post hoc multiple comparison testing. The findings of this study may help clinicians select adhesive systems that optimize prosthesis retention while minimizing skin trauma and patient burden during long-term maxillofacial rehabilitation.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Kerala
-
Kochi, Kerala, India, 682041
- Amrita School of Dentistry, Amrita Institute of Medical Sciences, Kochi, Kerala, India
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Healthy volunteers aged 18-30 years
- Willingness to participate and provide written informed consent
- No history of skin disease
- No known adhesive allergy
Exclusion Criteria:
- Age below 18 years or above 30 years
- Current use of medications affecting skin integrity or immune function
- Recent skin trauma, surgery, or active skin lesions
- Existing systemic disease affecting skin health
- Pre-existing dermatological conditions
- Pregnancy or lactation
- Known allergy or hypersensitivity to adhesives or silicone materials
- Participation in another clinical trial during the study period
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Adhesive Evaluation Group
All participants receive applications of five commercially available maxillofacial prosthetic adhesives at randomized skin sites on the volar forearms using standardized silicone strips.
Adhesive residue remaining on the skin after 8 hours of wear is quantitatively evaluated using gravimetric analysis.
|
Silicone-based maxillofacial prosthetic adhesive (Factor II Inc., USA) evaluated for adhesive residue remaining on skin following removal of standardized silicone strips after 8 hours of wear.
Silicone-based maxillofacial prosthetic adhesive (Factor II Inc., USA) evaluated for adhesive residue remaining on skin following removal of standardized silicone strips after 8 hours of wear.
Water-based maxillofacial prosthetic adhesive (Factor II Inc., USA) evaluated for adhesive residue remaining on skin following removal of standardized silicone strips after 8 hours of wear.
Water-based maxillofacial prosthetic adhesive (Factor II Inc., USA) evaluated for adhesive residue remaining on skin following removal of standardized silicone strips after 8 hours of wear.
Water-based maxillofacial prosthetic adhesive (ADM Tronics Inc., USA) evaluated for adhesive residue remaining on skin following removal of standardized silicone strips after 8 hours of wear.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of adhesive residue remaining on skin after 8 hours
Tidsramme: 8 hours
|
Quantitative assessment of adhesive residue remaining on the skin after removal of standardized silicone strips coated with maxillofacial prosthetic adhesives using gravimetric analysis.
|
8 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adhesive Failure Mode Classification
Tidsramme: 8 hours
|
Assessment of adhesive failure mode following removal of the silicone strip. Failure mode will be classified as:
Classification will be performed by visual inspection of the skin and silicone strip after removal. |
8 hours
|
|
Time Required for Complete Adhesive Removal (Cleanability Assessment)
Tidsramme: 8 hours
|
Cleanability will be assessed by measuring the time (in seconds) required to completely remove residual adhesive from the skin using a standardized cleaning procedure.
Lower cleaning times indicate greater cleanability.
|
8 hours
|
|
Comparison of Adhesive Residue Between Silicone-Based and Water-Based Adhesives
Tidsramme: 8 hours
|
Comparison of percentage adhesive residue remaining on skin between silicone-based and water-based adhesive formulations, measured using gravimetric analysis.
|
8 hours
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- McNichol L, Lund C, Rosen T, Gray M. Medical adhesives and patient safety: state of the science: consensus statements for the assessment, prevention, and treatment of adhesive-related skin injuries. Orthop Nurs. 2013 Sep-Oct;32(5):267-81. doi: 10.1097/NOR.0b013e3182a39caf.
- Rajasekaran R, Chander NG, Reddy JR, Balasubramanium M. Estimation of differences and reapplication effect of peel bond strength between silicone-based and water-based adhesives. J Prosthet Dent. 2024 Jun;131(6):1276-1279. doi: 10.1016/j.prosdent.2022.05.024. Epub 2022 Jun 25.
- Kiat-amnuay S, Gettleman L, Khan Z, Goldsmith LJ. Effect of adhesive retention on maxillofacial prostheses. Part I: skin dressings and solvent removers. J Prosthet Dent. 2000 Sep;84(3):335-40. doi: 10.1067/mpr.2000.109507.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- ECASM-AIMS-2024-085
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .