Gollins, S., Gaffney, C., Slade, S., & Swindell, R. (2008). RCT on gentian violet versus a hydrogel dressing for radiotherapy-induced moist skin desquamation. Journal of Wound Care, 17, 268–275.

To compare hydrogel dressing to gentian violet (GV) for healing moist desquamation

Patients were referred after a nurse or radiographer identified moist desquamation. They were randomly assigned to GV or hydrogel. Patients were given instruction on how to apply GV or hydrogel at home and were assessed by radiographers on alternate days until the healing occurred. Tracing of the moist desquamation area on to polythene sheets was done randomly on different days with different patients.

• The study sample (N = 30) was comprised of male (6.3%) and female (93.7%) patients with head and neck or breast cancer.
• Mean age was 61.2 years for the GV group and 57.4 years hydrogel group.
• Median dose was 50 Gy, with a range of 40–64.7 Gy.

The study took place at a single site in the United Kingdom.

The study used a randomized controlled trial design.

• The end point was the time to healing.
• The secondary end point was “area under the curve” of the plot of the median area of moist desquamation against time.
• Tracing of the area of moist desquamation was used as the measure.

• Median healing time was 12 days in the hydrogel group and 30 days in GV group.
• Ten of the 16 patients withdrew from the GV group, citing nonhealing and stinging.
• Three of the 14 patients in the hydrogel group withdrew because of stinging and noncompliance.
• Over the first seven days, there were no differences in the area of moist desquamation.
• Over 14 days, the hydrogel group had a smaller area (p = 0.003), but the area of moist desquamation increased from baseline in both groups.

The study could not support or refute the value of hydrogel dressings.

• The sample size was small, with less than 50 patients.
• There is no standard system to identify moist desquamation.
• Many patients withdrew from the study.
• The study was stopped because of the benefit seen in hydrogel.
• The study had a risk of bias because it was unblinded.
• There was no standard amount of GV applications (several times a day).
• Patients with head and neck cancer often were not nutritionally sound, and patients with breast cancer may not have as many comorbidities.
• No subgroup analysis was done.
• The report did not mention if chemotherapy given.
• Although time to healing was the main end point, no statistical analysis of differences in time to healing could be done.
• There were no standard time points of skin evaluations.