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 Link

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.