Dermatological Problems With Prosthetic Roll-On Liners

Michelle J. Hall, C.P.O., F.A.A.O.P.,Donald G. Shurr, C.P.O., P.T.
American Prosthetics & Orthotics, Inc.
Iowa City, Iowa

Marta J. VanBeek, M.D., M.P.H.
University of Iowa Department of Dermatology
Iowa City, Iowa

M. Bridget Zimmerman, Ph.D., M.S.
University of Iowa Department of Biostatistics
Iowa City, Iowa

Össur Kristinsson first developed the Icelandic roll-on silicone socket (ICEROSS) in the mid 1980's. This type of socket interface was quickly popularized in the prosthetic community and has become the standard of treatment for transtibial amputees. Multiple manufacturers of roll-on liners, of various materials, now exist. These companies claim that liners offer superior comfort, suspension, and relief of dermatological problems compared to previous prosthetic options. A review of relevant literature reveals studies that are limited by the lack of diagnoses made by dermatologists1-3 and a failure to identify the frequency of these problems4-5. The purpose of this study is to establish an incidence of dermatological problems in transtibial amputee subjects who utilize a roll-on liner with their prosthesis.

A questionnaire was sent to all transtibial amputees fitted by American Prosthetics & Orthotics, Inc. since 2000 with a total surface bearing prosthesis with roll-on liner. The survey determined demographic information, skin type, hygiene and prosthetic habits, co-morbidities and reported skin problems. Subjects were asked if they had ever experienced any of the following problems under the liner: allergic skin reaction, ingrown hair, heat rash, open sore, excessive sweating, red or irritated skin, odor, or itchy skin. All participants were offered a free skin examination by a dermatologist at the University of Iowa Hospital & Clinics to verify this medical history and document current skin problems. A chi-square, trend, and rank-sum test were used to associate various factors with specified skin problems.

Forty-one percent of 290 possible surveys were returned complete and 23 subjects (19%) received skin exams with the dermatologist. The population consisted of 92 men and 27 women with an average age of 58.3 years (range 19-85 yrs) and average time since amputation of 10.1 years (range 0.1-57 yrs). Most subjects (91%) reported the experience of a skin problem on the survey and twenty-two percent of subjects seen by the dermatologist had a problem at the time of the visit. Ninety-one percent of the subjects who shaved their limb complained of excessive sweating, which is significantly more often than those who did not shave (p = 0.0473). Fortynine percent of the subjects who used nothing between their skin and the liner experienced an offensive odor. This is a significantly greater number of subjects reporting an offensive odor as compared to those subjects who used nothing between their skin and liner (p = 0.0012). Compared to fair skinned individuals, more subjects with medium or dark skin reported problems with excessive sweating (76%, p = 0.0238) and skin itching (70%, p = 0.0262). When compared to less active individuals, significantly more active individuals complained of their skin itching (p = 0.0425). Subjects with diabetic and/or vascular related causes of amputation were significantly less likely to experience excessive sweating (46%, p = 0.0060). Liner characteristics, liner hygiene, race, hair color, co-morbidities, prosthesis wearing time and prosthesis fit did not significantly affect the reporting of skin problems. The skin exam data gathered by the dermatologist indicated that many subjects had a history of ulcers (52%), contact/irritant/frictional dermatitis (35%), and folliculitis (30%). This data also indicated that subjects commonly presented with lichenification (30%) and contact/irritant/frictional dermatitis (26%). Two tests of reliability and two tests of validity between the survey and physical exam showed no significant differences.

A cause and effect relationship between amputee habits and skin problems is not clear. For example, an explanation of why subjects used something between their liner and skin was not reported. This information may have explained why those subjects did not report an offensive odor. Lyon et al found that one third of their subjects had dermatological problems due to sub optimal prosthetic fit or use of cream, oil, talc, etc. on the skin (6). However, odor was not included as a skin problem in their study. Our data indicated that significantly more subjects who shaved their limb complained of excessive sweating than those who did not shave. This may be less due to actual amount of sweat produced than to the ability to feel the sweat. Those without hair on their limb may have better been able to feel the sweat than those with hair. These results conflict with those by Lake and Supan (2) who did not report any significant differences between the groups. Individuals with medium or dark skin often produce more oil on their skin. This extra production of oil may have led to the increase that we saw of sweat production and skin itching. It is logical that subjects who have increased activity levels would have higher body temperatures during activities and result in higher sweat production than those who reported low activity levels. Previous studies also reported that subjects wearing occlusive liners had complained of their skin itching and increased sweating with use of the liner, but that it decreased with increased time since fitting (1, 3). Due to vascular changes in subjects with diabetes and/or vascular compromise, it is no surprise that they reported significantly less problems with sweating than other groups. Data from this study indicated no significant differences in reported skin problems between subjects with poor or excellent hygiene habits. This coincides with Lake and Supan's study that found that all subjects who reported good hygiene still had skin problems (2). Many of the results from this study coincided with previous studies1-6.

As with any study, there are limitations. One limitation with this study is that the survey asked if subjects "Have ever experienced any of the following skin problems." It is unknown when these skin problems occurred. It is of interest whether the subjects who reported skin itching or excessive sweating found that these problems decreased over time. Due to this, it is recommended that a future study monitor new amputee subjects and have them follow-up with a dermatologist on a regular basis (i.e. every 6 months) over the course of several years to see what problems arise and how frequently they occur. It would also be interesting to examine how hygiene education may affect the subjects hygiene habits and the frequency of dermatological problems reported. Another limitation of this study was its use of a survey to gather information. Similar to any other survey based study, subjects freely responded to questions on the survey. Therefore, it relied on the accuracy of the patient's memory versus physician's notes. If a future study was performed as a prospective versus retrospective study, it may be possible to more accurately describe the cause-effect relationship of some of the variables examined in this study, as well as to determine the frequency of the problems. Finally, although the information derived from the dermatological exams is sound, only a small percentage (19%) of subjects who returned their survey also received a skin examination with the dermatologist. This small sample made it impossible to use statistical analyses on the data. It is likely that the high gasoline prices at the time and the distance that subjects living in rural Iowa would have had to travel to receive an exam deterred subjects from participating. In the future, it is recommended the subjects who receive a skin examination also be reimbursed for mileage.

This study used a questionnaire and a skin exam with a dermatologist to exam types of skin problems reported and possible causes in transtibial amputee subjects who utilize a roll-on liner. Incidence of various dermatological problems was determined and conclusions of possible problems drawn. Data compared between the questionnaire and dermatological exam were determined to be valid and reliable. It is apparent that a greater number of transtibial amputees who utilize a roll-on liner have dermatological problems.

This research project was funded by OSSUR and American Prosthetics & Orthotics, Inc.

References:

  1. Cluitman J, Geboers M, Decker J, Rings F. "Experiences with Respect to the ICEROSS System for Trans-tibial Prostheses." Prosthetics and Orthotics International. 1994; 18: 78-83.

  2. Lake C, Supan TJ. "The Incidence of Dermatological Problems in Silicone Suspension Sleeve Users." Journal of Prosthetics and Orthotics. 1997; 9(3): 97- .

  3. Hachisuka K, Nakamura T, et al. "Hygiene Problems of Residual Limb and Silicone Liners in Transtibial Amputees Wearing the Total Surface Bearing Socket." Archives of Physical Medicine and Rehabilitation. 2001 Sept; 82: 1286-9.

  4. Levy SW. "Skin Problems of the Leg Amputee." Prosthetics and Orthotics International. 1980; 4: 37-44.

  5. Dudek NL, Marks MB, Marshall SC, Chardon JP. "Dermatologic Conditions Associated with Use of a Lower-Extremity Prosthesis." Archives of Physical Medicine and Rehabilitation. 2005 April; 86: 659-663.

  6. Lyon CC, Kulkarni J, Zimerson E, et al. "Clinical Review: Skin Disorders in Amputees." Journal of the American Academy of Dermatology. 2000 Mar; 42(3): 501-7.