Zhong, W.H., Tang, Q.F., Hu, L.Y., & Feng, H.X. (2013). Mepilex Lite dressings for managing acute radiation dermatitis in nasopharyngeal carcinoma patients: A systematic controlled clinical trial. Medical Oncology, 30, 761.

DOI Link

Study Purpose

To compare the effectiveness of Mepilex® Lite dressings versus usual care in the time to healing of postirradiation dermatitis in patients with nasopharyngeal carcinoma

Intervention Characteristics/Basic Study Process

  • Control arm: Routine wound care and cleansing with a saline solution
  • Intervention arm: Wound cleansing followed by application of Mepilex Lite dressing
  • Primary endpoint: Time to wound healing (i.e., time between recruitment and complete reepithelialization with absence of any moist desquamation)
  • Signs of infection also were measured.
  • Assessments were made at baseline and then every Monday, Wednesday, and Friday.

Sample Characteristics

  • N = 88 started, 83 completed    
  • AGE = Adults aged 50 years or younger (n = 50), adults aged 50 years or older (n = 38) 
  • MALES: 62.5% (n = 55), FEMALES: 37.5% (n = 33)
  • KEY DISEASE CHARACTERISTICS: Nasopharyngeal carcinoma
  • OTHER KEY SAMPLE CHARACTERISTICS: Concurrent chemoradiation, three cycles of neoadjuvant cisplatin and 5FU chemotherapy, Chinese patients. There was no significant difference in the participant characteristics between the treatment and control arm.  These characteristics include age, Karnofsky Performance Status Scale, initial wound size, cancer staging, or radiotherapy technique.

Setting

  • SITE: Single site  
  • SETTING TYPE: Inpatient  
  • LOCATION: Southeast Asia

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

This was a systematic, inpatient, controlled clinical trial investigating the effect of Mepilex Lite dressings on radiation-induced dermatitis in patients with nasopharyngeal cancer who were undergoing curative-intent radiotherapy.

Measurement Instruments/Methods

  • Modified Radiation Induced Skin Reaction Assessment Scale (RISRAS) was used to assess erythema, dry desquamation, moist desquamation, necrosis, and patient symptoms such as pruritus, burning, discomfort, and impact on daily life.
  • Wound pain was measured using a visual analog scale of 0–10
  • Sleep problem, neck mobility, and appearance disturbance were measured using a 10-point Likert scale of 0 (less) to 10 (more distress) 

Results

Median time to wound healing  was 16 days (95% CI 12–19 days) in the Mepilex Lite group and 23 days (95% CI 19–27 days) in the control group (p = 0.009). Initial wound size of greater than or equal to 10 cm2 (p = 0.005), lymph node classification of 3 (p < 0.001), and AJCC overall stage III and IV (p = 0.003) were associated with prolonged wound healing time. No signs of infection were identified in either group. Participants in the Mepilex Lite group had significantly less (X = 4.38) sleep problems than the control group (X = 7.23, p = 0.005). Wound pain was significantly less in the Mepilex Lite group (X = 5.31) as compared to the control group (X = 6.89, p = 0.02). There was no difference in the neck mobility and appearance disturbance between the treatment and control groups.

Conclusions

Mepilex Lite dressing provides a promising alternative in the treatment of radiation dermatitis in nasopharyngeal carcinoma and is worthy of further research.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Other limitations/explanation: It would have been impossible to blind the researchers or the participants when only one arm involved a dressing.

Nursing Implications

This was a small, randomized, controlled clinical trial that was not blinded. Mepilex Lite dressing significantly decreased the time to wound healing of radiation dermatitis among individuals being treated for nasopharyngeal carcinoma. Additional studies are needed in a large, more diverse population of patients with cancer.