Silver Leaf Dressings

Silver Leaf Dressings

PEP Topic 
Radiodermatitis
Description 

Silver is known to have antimicrobial effects, and silver leaf nylon dressing has been shown to enhance healing with burns and skin grafts, as well as have anti-infective properties. Use of silver leaf nylon dressing was evaluated in patients with cancer for the treatment of radiodermatitis.

Effectiveness Not Established

Research Evidence Summaries

Aquino-Parsons, C., Lomas, S., Smith, K., Hayes, J., Lew, S., Bates, A. T., & Macdonald, A. G. (2010). Phase III study of silver leaf nylon dressing vs standard care for reduction of inframammary moist desquamation in patients undergoing adjuvant whole breast radiation therapy. Journal of Medical Imaging and Radiation Sciences, 41, 215–221.

doi: 10.1016/j.jmir.2010.08.005
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Study Purpose:

To evaluate the use of silver leaf nylon dressings as a prophylactic measure to reduce inframammary fold radiation therapy (RT)–induced dermatitis in women receiving adjuvant whole-breast RT compared with standard skin care. The secondary objective was to evaluate if the dressing influenced breast skin–related pain, itching, and burning resulting from whole-breast RT.

Intervention Characteristics/Basic Study Process:

Patients were randomized during their first week of RT using a random numbers table after stratification for prior anthracycline-based chemotherapy and duration of RT:  short course (42.5 Gy/16 fractions) or extended course (45-50 Gy/25-28 fractions).

Control Arm (n = 103):  Standard skin care recommendations included avoiding skin irritants, promoting clean skin using nonalkaline, unscented soap and water and patting skin dry, and maintaining skin hydration with twice daily (BID) application of moisturizing cream (patients chose which brand of cream they used). Pruritis or brisk erythema was managed with topical steroids. Moist desquamation was treated with BID saline compresses and hydrogel or silvadene cream.

Experimental Arm (n = 93):  Patients were supplied with dressings, sterile water, a cotton bra in the correct size, gauze, hypoallergenic tape, printed instructions, and teaching performed by RT therapists to show patients how to wear the dressing before day six of RT. Sterile water was used to moisten the dressing before applying it to the inframammary fold with gauze to cover it. This was held in place with the cotton bra and was to be worn 24 hours per day but removed for RT and bathing. The dressing was worn from day 6 of RT until 14 days after completion of whole-breast RT. Women in this arm also received standard skin care instruction. Patients were assessed one week before the last treatment, on the final day of treatment, and one week posttreatment (the time period when RT-induced dermatitis was likely to have appeared in the inframammary fold). Subjective and objective assessments of radiodermatitis in the inframammary fold were performed at these time points.

Sample Characteristics:

  • The sample was comprised of 196 patients (100% female) with breast cancer.
  • Mean age was 56 years in the control group and 58 years for silver leaf dressing group.
  • Patients were undergoing whole-breast RT for in-situ or invasive breast cancer after breast-conserving surgery.
  • Patients were excluded if they had an allergy to silver, significant connective tissue disease, known RT hypersensitivity syndrome, or significant wound complication (infection or dehiscence).

Setting:

Canada:  The British Columbia Cancer Agency

Phase of Care and Clinical Applications:

Patients were undergoing the active treatment phase of care.

Study Design:

The study was a randomized, controlled trial.

Measurement Instruments/Methods:

  • Digital photographs    
  • Radiation Therapy Oncology Group (RTOG) visual score to grade acute toxicity of RT-induced skin erythema
  • Breast questionnaires specifically developed for the study

Results:

  • Objective data assessment:  RTOG scores showed no significant difference in the presence of or maximum area of moist desquamation, erythema, or RTOG skin toxicity between study arms.
  • Subjective data assessment:  Symptoms of pain, burning, and itching increased during RT. Two weeks after completion of whole-breast RT, these symptoms had not returned to baseline. There was no difference between the study arms in patients reporting symptoms of pain or burning. In the last week of RT and one week post completion of RT, patient reports of itching decreased in the experimental arm (p = 0.013 and .019, respectively). Patients using Glaxal Base cream reported worse burning one week before RT finished (p = 0.02), and those who used aloe vera reported worse pain and burning (p = 0.006 and p = 0.003, respectively). Patients who had not used moisturizing cream reported less pain (p = 0.02).

Conclusions:

The use of silver leaf nylon dressings as a prophylactic measure did not show benefit in reducing the degree of acute inframammary fold radiodermatitis in women receiving adjuvant whole-breast RT.

Limitations:

  • Not applicable
  • The authors identified potential reasons for negative outcomes:  weakness in study design/implementation or that the silver leaf dressing had no effect in preventing inframammary radiodermatitis.  

Nursing Implications:

The prophylactic use of silver leaf nylon dressings decreased the patient-reported symptom of itching on the last day of RT and one week after completion of whole-breast RT. Dressings can provide patient comfort, and the use of dressings is supported perhaps on a more individual per-case basis; however, the results did not demonstrate a significant benefit for prophylactic silver leaf dressing use.

Niazi, T. M., Vuong, T., Azoulay, L., Marijnen, C., Bujko, K., Nasr, E., . . . Cummings, B. (2012). Silver clear nylon dressing is effective in preventing radiation-induced dermatitis in patients with lower gastrointestinal cancer: results from a phase III study. International Journal of Radiation Oncology, Biology, Physics, 84, e305-e310.

doi: 10.1016/j.ijrobp.2012.03.062
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Study Purpose:

To compare the efficacy of silver clear nylon dressing to standard skin care for the prevention and treatment of radiodermatitis in patients with anal canal and rectal cancer receiving chemoradiation therapy (XRT).

Intervention Characteristics/Basic Study Process:

Patients were randomized to receive the silver dressing beginning on day 1 of radiation treatment or standard of care if radiation-induced dermatitis developed. Standard care involved using sulfadiazine cream at the time of development of grade 1 dermatitis. Patients wore the dressing 24 hours/day, seven days/week, except during XRT delivery. This was continued until two weeks after completion of XRT. The primary study outcome was skin toxicity at the last day of XRT. Skin toxicity was rated by multiple observers from digital photographs of the perineal skin area.

Sample Characteristics:

  • The sample was comprised of 38 patients (50% male, 50% female).    
  • Mean age was 63.8 years.
  • Of the patients, 70% had disease of the anal canal and the rest had rectal cancer.
  • Of the patients, 75% had 54 Gy or more of XRT. All received concurrent chemotherapy with 5 FU. Those with anal canal disease also received mitomycin C.

Setting:

  • Single site 
  • Outpatient 
  • Canada

Phase of Care and Clinical Applications:

Patients were undergoing the active antitumor treatment phase of care.

Measurement Instruments/Methods:

Skin scoring system grade 0–4:  grading by all 10 observers was calculated as the average score x10.

Results:

All patients completed XRT without major toxicity. There were four treatment breaks in the standard care arm and three in the silver dressing arm. On the last day of treatment, the mean dermatitis score was 2.53 for the standard arm and 1.67 for the silver dressing arm. When adjusted for age, there was no significant difference between groups in terms of severity of radiodermatitis.

Conclusions:

There were no clear differences between study groups that indicated a substantial benefit for use of silver dressings.

Limitations:

  • The study had a small sample size.
  • The study had a risk of bias due to no blinding.
  • Measurement/methods were not described.
  • Measurement validity/reliability was questionable.*
  • The intervention was expensive, impractical, or required training.*

*Dressings were provided free of charge; however, they are generally expensive. Measurement methods were unclear; the authors stated calculation of dermatitis severity using all 10 observer scores but then reported analysis only of average findings in each group. Findings showed no significant difference or meaningful size of effect; however, the authors concluded that the dressing was beneficial, which showed bias in the reporting.

Nursing Implications:

The study did not provide strong support for the efficacy of silver nylon dressing to prevent radiation-induced dermatitis with radiation to the perineal area and skin.

Vavassis, P., Gelinas, M., Chabot Tr, J., & Nguyen-Tân, P. F. (2008). Phase 2 study of silver leaf dressing for treatment of radiation-induced dermatitis in patients receiving radiotherapy to the head and neck. Journal of Otolaryngology-Head and Neck Surgery, 37, 124–129.

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Study Purpose:

To investigate the effectiveness of silver leaf dressings in treating radiation-induced dermatitis compared with the current standard of care (silver sulfadiazine).

Intervention Characteristics/Basic Study Process:

Patients presenting with grade 2 or greater skin toxicity within radiation portals were offered the topical treatment of silver sulfadiazine (application three times daily and removed prior to daily radiation) and silver leaf dressing worn constantly (removed only for radiation treatments).

Each patient applied silver leaf dressing on one side of the neck and silver sulfadiazine on the other.

Silver leaf dressing and silver sulfadiazine were each assigned randomly to each side of the patient’s neck.

Sample Characteristics:

  • Twelve patients were entered, and five completed the study.
  • Age and gender were not reported.
  • Patients had squamous cell carcinoma of the base of the tongue, tonsillar fossa, oropharynx, hypopharynx, or larynx.
  • Radiation doses varied from 60 Gy in 30 fractions to 72 Gy in 42 fractions.
  • The majority of patients received 70 Gy in 35 fractions.
  • Five of the 12 patients received concurrent platinum-based chemotherapy.

Study Design:

The study used a quasiexperimental design; patients were used as their own controls.

Measurement Instruments/Methods:

  • Patients were evaluated weekly (or more) by a treating physician. At evaluations, patients were questioned regarding quality of pain control by the treating physician and an independent research coordinator.
  • Radiation Therapy Oncology Group (RTOG) acute skin toxicity scoring system was used to grade dermatitis.
  • Digital photographs were taken to establish baseline skin status, as well as for follow-up during and after.
  • Three physicians were presented with digital photographs and were asked to evaluate and grade skin toxicity, as well as compare both sides of the head and neck of patients.

Results:

  • No difference in improvement was reported between the control and test sides in any patient with regard to RTOG grade throughout the duration of application of both modalities. However, within the same grade, two of three observers agreed on some degree of improvement in dermatitis with silver leaf dressing compared with silver sulfadiazine.
  • Eight of the 12 patients (67%) subjectively reported improved pain control on the side treated with silver leaf dressing.
  • Seven of the 12 patients (58%) on the silver leaf dressing treatment side presented with smaller regions of same-grade dermatitis with a tendency toward faster healing.
  • Four of the 12 patients (33%) had equivalent results with both treatment modalities.
  • Duration of healing varied between 7 and 28 days.
  • Within the same RTOG grade, sliver leaf dressing appeared to provide greater relief of pain and greater skin condition.

Conclusions:

Silver leaf dressing does not appear to be superior to standard treatment for radiation-induced dermatitis when the RTOG grading system is used.

Limitations:

  • The study had a very small sample, and less than one-half of patients completed the study.
  • No formal pain assessment scale was consistently used during pain assessment.
  • The potential impact of concurrent chemotherapy on healing could not be evaluated or discussed.
  • Because of the subjective nature of evaluation of dermatitis within RTOG grade, the opinion of the majority of observers served to classify response of dermatitis. It would be more reliable to have averaging of observations.
  • The study lacked strict guidelines to ensure conformity to treatment.

Vuong, T., Franco, E., Lehnert, S., Lambert, C., Portelance, L., Nasr, E., … Freeman, C. (2004). Silver leaf nylon dressing to prevent radiation dermatitis in patients undergoing chemotherapy and external beam radiotherapy to the perineum. International Journal of Radiation Oncology, Biology, Physics, 59, 809–814.

doi: 10.1016/j.ijrobp.2003.11.031
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Study Purpose:

To evaluate silver leaf nylon dressing (SLND) in preventing radiodermatitis in patients undergoing radiation therapy (RT) and concurrent chemotherapy.

Intervention Characteristics/Basic Study Process:

  • Fifteen consecutive patients with anal canal or gynecologic cancer were offered SLND as a preventive intervention.
  • Selected patients were asked to wear SLND from day 1 of treatment until two weeks after the end of treatment.
  • SLND was kept in place with thong underwear (and a pad as needed) and was kept moist as recommended by the manufacturer.
  • Compliance in applying dressing was evaluated weekly by the treating physician.
  • All patients were instructed to use soap and water on the perineum during a course of pelvic RT.
  • The historical control group consisted of 12 patients from a prior institutional study that used conformal RT for anal canal cancer and three patients with gynecologic cancer who refused to participate in current study. Control patients used sulfadiazine at the occurrence of symptomatic dermatitis, per routine for the institution.
  • Ten observers unaware of the treatment intervention were enrolled to evaluate skin changes.

Sample Characteristics:

  • The sample was comprised of 15 patients using SLND and 15 historical controls.
  • Age ranged from 38 to 92 years for SLND patients and 47 to 77 years for historical control patients.
  • The SLND group included 10 women and 5 men, and the historial control included 11 women and 4 men.
  • Patients had anal canal (n = 12) and gynecologic cancer (n = 3).
  • Patients were undergoing combined external beam RT and chemotherapy.

Setting:

Montreal General Hospital, Montreal, Quebec

Study Design:

The study was a phase 2, single-arm trial with a historical control comparison.

Results:

  • No toxicity was associated with use of SLND, and no allergic reaction was documented in the patient cohort.
  • During treatment, compliance was 100%.
  • Two weeks after treatment, compliance was 70%—no wear was cited most frequently due to absence of symptoms.
  • All patients completed treatment without interruption.
  • There were three grade 3 scores in the SLND group compared with 92 grade 3 and 4 scores in the control group.
  • Mean dermatitis score was 2.62 (standard deviation [SD] = 0.48) for controls. Mean dermatitis score for the SLND group was significantly lower at 1.16 (p < 0.0001).

Conclusions:

The results suggest that SLND can be effective in reducing radiodermatitis.

Limitations:

  • The study had a very small sample.
  • Digital photography, although a useful tool, has not been evaluated in clinical studies.
  • The study lacked random treatment assignment and used historical controls rather than a prospective design.
  • In three female patients, patchy, moist desquamation was observed over the labia minora and around the urethra, an area not covered by the SLND—the effect of SLND is limited to immediate tissues in direct contact with dressing.
  • The question of selective protection of normal tissues by the SLND could be raised. SLND was removed during RT.
  • SLND is costly.

Systematic Review/Meta-Analysis

Salvo, N., Barnes, E., van Draanen, J., Stacey, E., Mitera, G., Breen, D., . . . De Angelis, C. (2010). Prophylaxis and management of acute radiation-induced skin reactions: A systematic review of the literature. Current Oncology (Toronto, Ont.), 17(4), 94–112.

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Purpose:

To review the evidence for approaches to prevention and management of radiodermatitis

Search Strategy:

Databases used were MEDLINE, PubMed, and Cochrane Library. Keywords searched were skin reactions, radiation, radiation adverse effects, erythema, desquamation, and radiodermatitis. Studies were included in the review they

  • Were published reports or abstracts from January 1, 2000 to October 1, 2008.
  • Reported the method of skin grading.

Studies were excluded from the review if they were letters, comments, editorials, case reports, practice guidelines, systematic reviews, or meta-analyses.
 

Literature Evaluated:

The total references retrieved and the quality rating approach were not reported.
 

Sample Characteristics:

  • Thirty-nine trials were included in the review.
  • Patients were receiving radiation therapy.

Phase of Care and Clinical Applications:

Patients were undergoing active antitumor treatment.

Results:

Washing practice, topical corticosteroids, aloe vera, biafine, hyauronidase-based creams, sucralfate, miscellaneous creams, Amifostine, oral enzymes, pentosifylline, dressings, non-steroidal topical cream, topical colony-stimulating factors supplements, and mode of radiation delivery were reviewed. Other agents studied included beladonna 7CH and a Chinese remedy, lian bai liquid.

Conclusions:

There is lack of support for Biafine use. There is some evidence to suggest that topical corticosteroids may be beneficial. Evidence for non-steroidal topical agents is conflicting. Evidence does not support use of Aloe Vera or sucralfate cream. Some evidence to suggest that light-emitting diode, pentoxifylline, sliver-leaf dressings, washing, zinc supplements and intensity-modulated radiation therapy are beneficial.

Limitations:

  • The trials were small and had numerous design and reporting limitations.
  • Secondary trials evaluated the same agent or treatment, making comparison very difficult.

Nursing Implications:

Further research is needed in this area. Intervention goals, prevention or treatment need to be clear and further work is needed to develop and validate more sensitive assessment tools. Further work is also needed to evaluate differences in risk based on anatomical sites.


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