No Sting Barrier (Cavilon™ No Sting Barrier Film)

No Sting Barrier (Cavilon™ No Sting Barrier Film)

PEP Topic 
Radiodermatitis
Description 

Cavilon™ No Sting Barrier Film is a liquid produce that dries after application to form a barrier to protect the skin. Use of this product was studied for the prevention of moist desquamation radiodermatitis in patients with cancer.

Effectiveness Not Established

Research Evidence Summaries

Graham, P., Browne, L., Capp, A., Fox, C., Graham, J., Hollis, J., & Nasser, E. (2004). Randomized, paired comparison of no-sting barrier film versus sorbolene cream (10%
glycerine) skin care during post mastectomy irradiation. International Journal of Radiation Oncology, Biology, Physics, 58, 241–246.

doi: 10.1016/S0360-3016(03)01431-7
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Study Purpose:

To test the effect of prophylactic 3M Cavilon no-sting barrier film (no-sting) on the rates of moist desquamation compared with sorbolene cream (10% glycerin).

Intervention Characteristics/Basic Study Process:

The chest wall was divided into medial and lateral halves, with one half treated with no-sting and the other with sorbolene. No-sting was applied by the nursing staff. Administration began at the start of radiation therapy until two weeks after completion. When a moist desquamation occured, the skin care changed to hydrocolloid dressing.

Sample Characteristics:

  • The study sample (N = 61) was comprised of female patients with breast cancer.
  • Mean age was 58 years, with a range of 30–88 years.
  • Thirty-seven patients received chemotherapy, 13 concurrently and 24 sequentially.
  • Radiation therapy used a 6 MV photon beam at a dosage of 50 Gy applied tangentially in 25 fractions.

Setting:

The study took place across multiple sites in Sydney, Australia.

Study Design:

The study used a quasi-experimental design with patients as their own control.

Measurement Instruments/Methods:

  • Patients were assessed from week 1–12.
  • The Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer skin scoring assessment was done weekly.
  • A five-point Likert scale was used to measure pain and pruritus for each area of the skin.

Results:

  • Skin dosimetry data in the nonbolus area confirmed that no difference was present in the buildup effect (or lack thereof) between sorbolene and no-sting in those areas outside the skin covered with the bolus material.
  • For skin reaction score (p = 0.005) and pruritus (p = 0.011) the no-sting scores were less.
  • No evidence was found of a statistically significant trend in the relationship to pain scores or analgesia requirements.
  • Nine patients required analgesics for skin reaction in the sorbolene group and eight patients in the no-sting.
  • The cost and nursing time was relatively the same per patient, but the peak skin reactions occurred several weeks after radiation therapy was completed.
  • Two patients in the no-sting group had treatment delays because of pruritus.

Conclusions:

No-sting may be beneficial in the mitigation of skin toxicity with radiation therapy.

Limitations:

  • The study did not provide a control group without alternative treatment for comparison.
  • In longitudinal follow-up at six weeks data analysis, they included cases for which it was stated that no data was available. It was not clear how these were handled.
  • Initial cost of the product showed that no-sting was more expensive.
  • There was no subgroup analysis based on concurrent chemotherapy.
  • The sample size was small given the variability in patient treatment regimens.

Shaw, S.Z., Nien, H.H., Wu, C.J., Lui, L.T., Su, J.F., & Lang, C.H. (2013). 3M Cavilon No-Sting Barrier Film or topical corticosteroid (mometasone furoate) for protection against radiation dermatitis: A clinical trial. Journal of the Formosan Medical Association.

doi: 10.1016/j.jfma.2013.04.003
Print

Study Purpose:

To investigate the effect of 3M™ Cavilon™ No-Sting Barrier Film and topical corticosteroids on irradiated skin

Intervention Characteristics/Basic Study Process:

Thirty-nine post-operative patients with breast cancer were assigned to the three intervention groups using simple randomization. The three treatment groups included 3M barrier film versus no treatment [n = 13], Elomet® (mometasone furoate [corticosteroid] cream) versus no treatment [n = 9], and Elomet versus 3M barrier film [n = 17]. Each participant’s treatment field was divided in half so that she received both radiodermatitis treatments assigned to the group. Elomet and 3M film barrier were applied every other day, excluding weekends, by the same staff, and the reactions were observed. For patients with more advanced disease, chest wall recurrence, or lymph node involvement, those areas also were irradiated. The skin reactions in the neck and supraclavicular areas were not included in the study. The primary end points were time to onset of grade 1 pruritus, a pain score of 3, and presence of grade 2 dermatitis. The secondary end points were grade 3 radiodermatitis and pain scores by each treatment.

Sample Characteristics:

  • N = 39  
  • AGE = 30–76 years
  • MEAN AGE = 51 years
  • MALES: 0%, FEMALES: 39%
  • KEY DISEASE CHARACTERISTICS: Breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Chest wall, remaining breast after conservative surgery, treated skin, untreated skin, post-operative

Setting:

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Taiwan

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active antitumor treatment

Study Design:

Open-label clinical trial of barrier film or corticosteroid cream, versus no treatment to prevent/reduce grade 1 pruritus, grade 2–3 radiodermatitis, and pain score of 3.

Measurement Instruments/Methods:

  • Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 for dermatitis associated with radiation and for pruritus
  • A pain score was collected.
  • SPSS software version 10 was used to analyze the data.

Results:

The only statistically significant result in this study was that Elomet significantly delayed the onset of grade 2 dermatitis as compared to 3M No-Sting Barrier Film. Grade 2 dermatitis: Elomet (53.4 days on treatment) versus 3M No-Sting Barrier Film (44.5 days on treatment), p = 0.002; 3M No-Sting Barrier Film (44.2 days on treatment) versus no treatment (46.6 days on treatment), p = 0.196; and Elomet  (52 days on treatment) versus no treatment (43 days on treatment), p = 0.092
 
Participants who received 3M No-Sting Barrier Film experienced a non-significant delay in grade 1 pruritus as compared to Elomet. Grade 1 pruritus: 3M No-Sting Barrier Film (32.4 days on treatment) versus Elomet (28.4 days on treatment), p = 0.072; 3M No-Sting Barrier Film (32.5 days on treatment) versus no treatment (29.4 days on treatment), p = 0.079; and Elomet  (26.4 days on treatment) versus no treatment (26.8 days on treatment), p = 0.413
 
There was no significant difference in the pain score of 3 in any arm.
 
Skin treated with Elomet had the lowest incidence of grade 3 dermatitis, but not at a significant level. Grade 3 dermatitis incidence: 3M No-Sting Barrier Film (33%), Elomet (15%), and no treatment (23%), p  = 0.289

Conclusions:

The authors recommend using the barrier film starting at the commencement of treatment to reduce friction and irritation, particularly in skin folds and the axilla. However, study findings here do not show an effect on development of radiodermatitis. Once pain and hyperemia occur, the barrier film is discontinued and corticosteroid cream started. The effectiveness of corticosteroid on prevention of radiodermatitis should be investigated further under a lager randomized study.

Limitations:

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Key sample group differences that could influence results
  • Measurement/methods not well described
  • Intervention expensive, impractical, or training needs
  • Other limitations/explanation:  The researchers said they used “simple randomization” to assign the participants to the three treatment groups. They did not explain what they meant by “simple randomization.” The number of participants in each treatment group differed. Demographics for the members of each treatment arm were not provided. Some participants were receiving first-line treatment for a new breast cancer. Others were experiencing a recurrence. Some participants had a modified radical mastectomy, and some had breast-conserving surgery. The authors did not report the use of a power analysis to determine the sample size required to accurately identify statistically significant differences between the treatments, nor the expected effect size of the intervention. It is unlikely that 13 participants in each treatment arm would provide enough power to detect significant differences. The participants in the 3M barrier film versus no treatment and the Elomet (mometasone furoate [steroid] cream) versus no treatment arms served as their own control. The participants in the Elomet versus 3M barrier film arm did not have a control. The volume and type of tissue in each half of the treatment field may not have been identical. The skin dose in each half may have differed and was not reported in this article. Inter-rater reliability was not reported. The method of measuring pain score was not reported.  A pain score of 3 was an endpoint, but the range was not identified.
 

 

Nursing Implications:

The effectiveness of corticosteroids on prevention of radiodermatitis should be investigated further in a large, randomized, controlled clinical trial with adequate power to detect clinically significant differences and controlling for confounding factors.


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