2025 Volume 67 Issue 4 Pages 201-204
This study aimed to evaluate the stick behavior and performance of an adhesive for facial prostheses on esthetics and strength. Forty subjects participated in this study. Mimic the skin was fabricated, applied to one cheek of each subject using only medical adhesive, and to the opposite cheek using the same medical adhesive and an overlying film dressing. Ninety-five percent of subjects reported that the silicone prosthesis with film dressing did not peel off and was less noticeable. The combination of medical adhesive and film dressing provided stronger adhesion and better esthetics compared to medical adhesive alone.
Maxillofacial defects, successive issue tumors, trauma, inflammation, or congenital deformities have been managed through the application of facial prostheses, with or without reconstructive surgeries [1]. Facial prostheses do not require surgery, and employ silicone material to restore morphological and esthetic features [2]. This use of facial prostheses could lead to improvements in esthetics, speech, swallowing, and respiratory functions, thus enhancing the quality of life of patients.
Maintenance of a facial prosthesis usually requires medical adhesives. When physiological muscle movements such as speech and mastication compromise secure attachment of the prosthesis with adhesive alone, or when the condition of the skin surrounding the affected area is unsuitable for adhesive application, surgical tape for bandage fixation is sometimes used [3]. This method is esthetically less desirable compared to medical adhesives alone.
There are many reports on facial prostheses such as transparent medical tapes including film dressings used for wound dressing [4,5,6]. However, literature on maintenance remains limited [5], and there are no reports on the use of film dressings for prosthesis adhesion.
This study was conducted to evaluate the adhesive performance of facial prostheses that are both esthetically pleasing and capable of withstanding sweat and physical muscle movements. Medical adhesive was combined with a film dressing in this study, as a technique not previously employed for achieving adhesion of facial prostheses. The adhesive used in this study was an acrylic-based adhesive.
The experiments in this study were conducted using a film dressing as a new adhesive method and assessed usability compared to the conventional method using medical adhesive alone. The null hypothesis was that no difference would be seen between fixation of prostheses with adhesive alone and those using a combination of adhesive and film dressing.
Participants were volunteers who sought research collaboration between August 29, 2023 (the date of approval by the ethics committee) and October 31, 2023.
Selection criteria(1) Subjects aged 20 years or older at the time of consent; and
(2) Participants who, after receiving a detailed explanation of their involvement in this study, provided voluntary consent based on a thorough understanding of the subject matter.
Exclusion criteria(1) Participants with skin hypersensitivity;
(2) Participants with a history of skin irritation from adhesive tape or alcohol; or
(3) Other subjects deemed by the principal investigator to be unsuitable as research subjects.
Recruitment of research subjectsPosters inviting healthy volunteers were displayed at the Faculty of Dentistry, Hokkaido University, Hokkaido University Hospital, universities conducting facial prosthesis research, and university hospitals providing facial prostheses.
MaterialsThe silicone specimen (GC Silfy Fast, GC, Tokyo, Japan) consisted of vinyl polysiloxane, silicic anhydride, and platinum catalyst (part A), and vinyl polysiloxane and silicic anhydride (part B). The silicone material used in this study is primarily intended for indirect relining materials used for facial prostheses. It was approved for use in facial prostheses with a connected fistula between the oral and nasal cavities to improve functions such as speech, mastication, and swallowing. The material was used for external facial prosthesis applications beyond its specific indication, with informed consent obtained from the subjects.
No medical adhesives have been approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Hydrobond (Daro Adhesive, Lakeside, AZ, USA), the most commonly used medical adhesive in Japan, was used in this study. This medical adhesive contains water-based acrylic polymer adhesive containing residual monomers, ammonia, and water. In addition, adhesives referenced in the “Manual of Facial Prosthetics” published by the Japanese Academy of Maxillofacial Prosthetics were used in this study. While prolonged or repeated skin contact may cause irritation, no cases of adverse skin reactions associated appear to have been documented for the products Hydrobond (manufactured by Factor II) and Daro Adhesive, according to their safety data sheets (SDSs).
Film dressings (Airwall UV, Kyowa Medical, Osaka, Japan), composed of polyurethane and acrylic adhesive, and removers (Uni-solve Adhesive Remover Wipes, Smith and Nephew, London, UK), containing dipropylene glycol methyl ether, G10-11-in paraffin, aloe extract, benzyl alcohol, and fragrance, although not classified as medical devices with low risk, are also commonly used in clinical settings in Japan.
Methods of implementation(1) The email addresses of the subjects were collected and used to contact them.
(2) All subjects were informed that the adhesive used in this study was not approved for medical use in Japan, and written consent was obtained prior to participation. Informed consent was obtained from subjects either in person or in writing using a web conferencing tool. Furthermore, subjects were informed that primary irritant contact dermatitis could still occur, even if they had no history of skin hypersensitivity.
(3) Within one month of obtaining consent, a dome-shaped silicone sample specimen (hereinafter referred to as “specimen”; 20 mm in diameter, 1.5-0.5 mm thick; GC Silfy Fast; GC [Material list, Table 1]) was affixed to one cheek of the subject using only medical adhesive (Hydrobond, Factor II; Daro Adhesive). The position of the prosthesis was set as follows: the center of the specimen was at the intersection of a vertical line descending from the outer corner of the eye and a line connecting the corner of the mouth and auricle. Pressure was applied for approximately 3 s to bond the specimen (Fig. 1).
(4) After affixing the specimen to the contralateral cheek with medical adhesive, a film dressing was applied (40-mm diameter, Airwall UV; Kyowa Medical) (Fig. 1).
(5) The specimen was left in place from waking until after bathing. Subjects were instructed to use a remover (Uni-solve Adhesive Remover Wipes) if necessary, when removing the medical adhesive or medical tape.
(6) Adherence status of the specimen was assessed using a questionnaire.
| Material | Brand name | Manufacturer | Composition | Lot number |
|---|---|---|---|---|
| Silicone sample specimen | GC Silfy Fast | GC, Tokyo, Japan | part A: vinyl polysiloxane, silicic anhydride, platinum catalyst | 2304261 |
| part B: vinyl polysiloxane, silicic anhydride | 2304261 | |||
| Film dressing | Airwall UV | Kyowa medical, Osaka, Japan | polyurethane, acrylic adhesive | 85929 |
| Medical adhesive | Hydrobond (Daro Adhesive) | Factor II. Inc., Lakeside AZ, USA | water-based acrylic polymer adhesive containing residual monomers, ammonia, and water | 7910 |
| Remover | Uni-solve Adhesive Remover Wipes | Smith & Nephew, London, UK | dipropylene glycol methyl ether, G10-11-in paraffin, aloe extract, benzyl alcohol, fragrance | 23070801 |
The silicone material used was GC Silfy Fast, commonly applied in facial prostheses. Hydrobond, a widely used medical adhesive in Japan, was employed, along with film dressings and removers routinely used in clinical settings.
A dome-shaped silicone specimen (20 mm diameter, 1.5-0.5 mm thick) was affixed to one cheek using a medical adhesive. The center was positioned at the intersection of a vertical line from the eye’s outer corner and a line from the corner of the mouth to the auricle.
The questionnaire survey was administered from August 29, 2023 (the date of the ethics committee approval) to October 31, 2023.
Statistical analysis (1) Number of casesThe study comprised a total of 40 cases.
(2) Basis for sample size determinationThe sample size was determined based on the feasibility of the study period. Addition of film dressings and medical adhesives was assumed to improve primary endpoints in 60% of cases, worsen them in 20% of cases, and maintain them in the remaining 20%. The level of significance was set at 5%, and the power at 80%. The required sample size for Wilcoxon’s signed-rank test was calculated to be 37, which was then rounded up to 40 cases.
(3) Analysis methodData were compiled in a spreadsheet (Excel; Microsoft Corporation, Redmond, WA, USA) and analyzed using statistical software (JMP version 17.0; JMP Statistical Discovery Software, SAS Institute Inc., Cary, NC, USA). Wilcoxon’s signed-rank test was used to assess the impact of film dressing maintenance on facial prosthesis adhesion. For statistical tests, differences at P < 0.05 were considered statistically significant.
Forty subjects (22 males, 18 females) completed the questionnaire, with a mean (± standard deviation) age of 40.1 ± 16.8 years (Table 2). The results are shown in Table 3.
| Category | Details |
|---|---|
| Total subjects | 40 |
| Male subjects | 22 |
| Female subjects | 18 |
| Median age | 40.1 years |
| Standard deviation | ±16.8 |
"Specimen only" indicating the method involving medical adhesive alone, and "specimen with film dressing" indicating the method utilizing both medical adhesive and film dressing
| Silicone sample only | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Ease of adhesion | Comfort of adhesive | Peeling | Peeling when bathing | Ease of removal | |||||
| Easy to adhere | 67% | Good | 45% | Did not peel off | 27% | Did not peel off | 20% | Easy to remove | 77% |
| Somewhat easy to adhere | 20% | Somewhat good | 25% | Partially peeled off | 35% | Partially peeled off | 20% | Slightly easy to remove | 12% |
| Slightly difficult to adhere | 13% | Slightly bad | 27% | Most of it peeled off | 8% | Most of it peeled off | 17% | Slightly difficult to remove | 3% |
| Hard to adhere | 0% | Bad | 3% | Peeled off | 30% | Peeled off | 43% | Hard to remove | 8% |
| Specimen with film dressing | |||||||||
| Ease of adhesion | Comfort of adhesive | Peeling | Peeling when bathing | Ease of removal | |||||
| Easy to adhere | 50% | Good | 72% | Did not peel off | 95% | Did not peel off | 87% | Easy to remove | 35% |
| Somewhat easy to adhere | 32% | Somewhat good | 18% | Partially peeled off | 5% | Partially peeled off | 10% | Slightly easy to remove | 27% |
| Slightly difficult to adhere | 15% | Slightly bad | 10% | Most of it peeled off | 0% | Most of it peeled off | 0% | Slightly difficult to remove | 28% |
| Hard to adhere | 3% | Bad | 0% | Peeled off | 0% | Peeled off | 3% | Hard to remove | 10% |
| Skin condition after removing the Specimen of "specimen only" and ”specimen with film dressing” | Is there a difference in appearance between silicone sample specimen only and Silicone sample specimen with film dressing? | ||||||||
| Silicone sample only | Specimen with film dressing | ||||||||
| Normal | 62% | Normal | 51% | Itching | 2% | Specimen with film dressing is less noticeable. | 70% | ||
| Normal, adhesive remained | 12% | Normal, adhesive remained | 8% | Tingling | 2% | I don't know. | 27% | ||
| Adhesive remained | 18% | Adhesive remained | 23% | Glue remained, itchy | 3% | Specimen only is more inconspicuous. | 3% | ||
| There was redness, and glue remained. | 3% | Had redness | 8% | There was redness/itching, but it disappeared quickly. | 3% | ||||
| Itching | 5% | ||||||||
Adhesion was significantly easier with the “specimen only” (P < 0.001).
Comfort of adhesionAdhesion with the “specimen with film dressing” was significantly more comfortable than with the “specimen only” (P < 0.001).
PeelingThe “specimen with film dressing” showed significantly less partial peeling once adhered (P < 0.001).
Peeling during bathingThe “specimen with film dressing” showed significantly less peeling during bathing (P < 0.001).
Ease of removalRemoval was significantly easier with the “specimen only” (P < 0.001).
Skin condition after removing the specimenThirty-eight percent of the “specimen only” participants answered that adhesive remained on the skin or that the skin showed redness after removal of the silicone specimen. However, 51% of participants reported more problems with residual adhesive, itching, and redness from the “specimen with film dressing” than from the “specimen only”.
Differences in appearance between “specimen alone” and “specimen with film dressing”Seventy percent of participants answered that the specimen with film dressing was less noticeable, suggesting superior esthetic performance of the specimen with film dressing.
Various studies have examined the use of double-sided tape and medical adhesives for facial prostheses [4,7], In particular, peel bond strength testing has been used to evaluate maxillofacial prosthetic silicone adhesives [8]. However, no studies appear to have focused on the use of film dressings for prosthesis adhesion.
On ease of adhesion, the “specimen alone” was shown to be more easily adhered. However, the combined percentage of respondents who answered that the “specimen with film dressing” was difficult or somewhat difficult to adhere was only 18%. Thus, this issue did not seem to be considered a major problem by participants and individuals could rapidly become accustomed to the method of applying film dressings.
On comfort, the “specimen with film dressing” was considered more comfortable. This could be attributed to the fact that the film dressing was extremely thin, reducing the diminishment of skin sensation.
On peeling off, the “specimen with film dressing” was easier to remove. The film dressing offered effective supplemental maintenance for medical adhesives, accommodating expansion and contraction of the skin [9].
On inadvertent peeling when bathing, the “specimen with film dressing” showed less peeling. This is due to the fact that the film dressing is highly waterproof and would provide protection against moisture for the medical adhesive.
On ease of removal, the “specimen with film dressing” demonstrated greater ease of removal. However, due to 0.07-mm thickness, the edges of the film dressing might be difficult to discern when peeling from the skin, particularly if the edge is not in a visible area.
On skin condition after film removal, the “specimen with film dressing” showed more adhesive residue, itching, and redness than the “specimen alone.” This is likely due, at least in part, to the high adhesive strength of the film dressing.
On the difference in appearance after bonding, 70% of participants answered that the “specimen with film dressing” was less noticeable. This was attributed to the anti-shine finish of the film dressing, allowing a closer match to the tone of the skin and making the boundary between the skin and specimen less noticeable.
Concurrent application of a film dressing and medical adhesive could be beneficial for the adhesion of facial prostheses. This is because the film dressing can remain adhered for an extended period even if some of the medical adhesive loses effectiveness due to perspiration or muscle movement. From the perspective of esthetics, the anti-shine finish of the film dressing reduces the visibility of the edges of the specimen, and an even more seamless appearance can be achieved with makeup. These findings suggest that the combination of medical adhesive and medical tape could be advantageous for facial prostheses in terms of both maintenance and esthetics.
This study has several limitations. First, participants were all healthy individuals, and the study was conducted on intact, healthy skin. This might not fully reflect clinical scenarios where facial prostheses are applied to patients with compromised or damaged skin, such as those recovering from surgery or with scar tissue. Further, the study focused only on short-term evaluations, and the long-term effectiveness of the methods remains unclear.
The null hypothesis for this study was rejected. Combined use of medical adhesive and film dressing resulted in superior adhesion and esthetic outcomes compared to the use of medical adhesive alone.
JMP: JMP statistical discovery software; PMDA: pharmaceuticals and medical devices agency; SAS: statistical analysis system; SDSs: safety data sheets; UV: ultraviolet
This study was approved by the Ethics Review Committee for Life and Medical Research at Hokkaido University Hospital. All study protocols were performed with the permission of the Director of Hokkaido University Hospital (Research No.: Finger 023-0177). All human subject experiments in this study adhered to the World Medical Association Code of Ethics (Declaration of Helsinki). All procedures were carried out with the full understanding and written consent of the subject.
The authors have no conflicts of interest to declare with respect to the results or funding.
This research was supported by JSPS KAKENHI Grant Number 23H05359 from the Japan Society for the Promotion of Science, Tokyo, Japan.
YW: conceptualization, data curation, formal analysis, funding acquisition, methodology, project administration, resources, visualization, writing – original draft; MK: methodology, investigation, writing – review and editing; TM: investigation, writing – review and editing; KN: conceptualization, methodology, investigation, writing – review and editing; TS: investigation, writing – review and editing; YU: supervision, writing – review and editing
1)YW*: y.wakabayashi@den.hokudai.ac.jp, https://orcid.org/0009-0001-5811-9245
1)MK: kawamura@den.hokudai.ac.jp, NA
1)TM: michida@den.hokudai.ac.jp, NA
2)KN: mountain24kawa@gmail.com, NA
3,4)TS: mail@takayoshi-suzuki.com, https://orcid.org/0000-0003-4020-967X
1,5)YU: ueda@den.hokudai.ac.jp, NA
Gratitude is extended to Dr. Atsuro Yokoyama of the Department of Oral Functional Prosthodontics, Division of Oral Functional Science, Faculty and Graduate School of Dental Medicine, Hokkaido University, Sapporo, Japan, for his invaluable guidance, insightful comments, and continuous encouragement throughout this research. Appreciation is also expressed to all research participants who completed the questionnaire. The Department of Dental Medical Laboratory at Hokkaido University Hospital, Sapporo, is acknowledged for its work in facilitating the survey.
The datasets analyzed for the present study are not publicly available due to ethical restrictions, but are available from the corresponding author on reasonable request. Reference materials used for adhesive selection are available at the website of the Japanese Academy of Maxillofacial Prosthetics (https://jamfp.sakura.ne.jp/wp-content/uploads/kaisetsusho_v2.0_20241202.pdf).
