Appendix 9: Evidence relating to the use of dressings in the management of radiotherapy induced skin reactions
++= high quality study
+= acceptable quality
0= rejected, unacceptable quality
not able to score= study had no control/comparison group or a case series
Dressing Type
Product
Design of Study (including
method, sample and main
outcomes)
Reference
Main Findings and Limitations
Quality
Assessment
Silicone-based foam
Low adhesion
Mepilex®Lite
Systematic controlled clinical
trial (patients as own control)
comparing Mepilex®Lite and
Aqueous cream BP in women
treated with radical RT to breast
N=24 evaluable
Outcomes: Radiation-Induced
Diggelmann, K., Zytkovicz,
A., Tuaine ,J. et al. 2010.
Mepilex ®Lite dressings for
the management of
radiation-induced
erythema: a systematic
inpatient controlled
clinical trial. Brit J Radiol
83: (995), 971–8.
Mepilex®Lite dressings statistically
significantly decreased the extent of
radiation-induced erythema
(p<0.001) although the average
increase in erythema score for
Mepilex® Lite was 1.65 and the
average increase in erythema score
for Aqueous cream BP was 2.41
(average difference =0.76) giving an
average difference less than one
category point on the scale so may
not be clinically significant. The
majority of women preferred them.
Bolus effect was very small (0.5mm)
and no difference in skin
temperature was found.
0
Skin Reaction Assessment Scale
(RISRAS), dose build-up, skin
temperature
Silicone- based foam
Low adhesion
Silicone -based foam
Low adhesion
Mepilex®Lite
Mepilex®Lite
Randomised controlled trial
(patients as own control)
comparing Mepilex®Lite and
Aqueous cream BP on first area
of erythema to appear during
radical RT to breast post
mastectomy.
N=74 evaluable patients.
Outcomes: RISRAS, time to moist
desquamation, time to healing
Paterson, D., Poonam, P.,
Bennett, N., et al. 2012)
Randomized intra-patient
controlled trial of Mepilex
®Lite dressings versus
Aqueous cream BP in
managing radiationinduced skin reactions
postmastectomy. JCancer
Sci Ther 04:347-56.
Randomised controlled trial
comparing the effectiveness of
Mepilex® Lite dressings and
usual care (described as wound
care and cleansing with normal
saline) in patients undergoing
chemo-radiation for
nasopharyngeal carcinoma.
NB preliminary results also
reported in Bennett N et
al. 2013. Proceedings from
RTi3 2013: Inquire, Inspire,
Innovate/Journal of
Medical Imaging and
Radiation Sciences 44
(2013) 44-58
Zhong, WH., Tang, QF., Hu,
LY., Feng, HX. 2013.
Mepilex® Lite dressings for
managing acute radiation
dermatitis in
nasopharyngeal carcinoma
patients: a systematic
controlled clinical trial.
Limitations: small trial, RISRAS
measurements stopped when dry
desquamation occurred, so effect on
more severe skin reactions not
assessed. No blinding of assessors
and no allocation concealment.
Mepilex®Lite dressings did not
significantly reduce the incidence of
moist desquamation, but reduced
the overall severity of skin reactions
by 41% (p < 0.001) and the average
moist desquamation score by 49% (p
= 0.043). 80% of participants said
they preferred the dressings over the
cream and RISRAS scores for
pain/discomfort, itchiness, burning
and effect on day to day life were
significantly better in the
Mepilex®Lite area.
Limitations: study only compared
dressings applied to the first area of
erythema to appear, which was not
always the worst affected area
overall.
Radiation-induced dermatitis in the
Mepilex® Lite group healed
significantly more quickly than in the
control group (median 16 days vs. 23
days, p=0.009). Although on
multivariate analysis, dressing type
was no longer a significant
determinant of time to wound
+
0
Hydrophilic
Polyurethane Foam
Non-adhesive
Silicone-based
transparent film
PolyMem®
Mepitel® film
N = 88
Outcome: Time to wound
healing; RISRAS, wound pain,
restriction of neck movement,
sleep and body image
disturbance.
Medical Oncology 30: (4),
761.
Case studies of PolyMem® in
patients with erythematous
radiation skin reactions (RTOG
>1) undergoing RT for head and
neck cancer
N = 20
Outcomes: pain and sleep diary,
healing
Scott, A. 2014. Polymeric
membrane dressings for
radiotherapy-induced skin
damage Br J
Nurs(Oncology
Supplement), 23(10), S24,
26-31
Randomised controlled trial
comparing prophylactic
Mepitel® film with Aqueous
cream BP (patients as own
control) during RT for breast
cancer
N = 80
Outcomes: skin reaction
severity, incidence of moist
desquamation
healing. Sleep, pain and combined
average researcher and patient
RISRAS scores were significantly
better in the Mepilex®Lite group.
Limitations: as with other studies,
this was not blinded. It was not
entirely clear at what point the
dressings were first applied.
Hers, P., Bennett, N.,
Sutherland, A., Peszynski,
R., Paterson, D., Jasperse,
M. 2014. Prophylactic use
of Mepitel® film prevents
radiation-induced moist
desquamation in an intrapatient randomised
controlled clinical trial of
78 breast cancer patients.
Radiotherapy and
Oncology 110:1, 137-143.
Pain and sleep scores improved
Not able to
during the radiotherapy treatment
score
course after PolyMem® dressings had
been applied. Skin had healed within
a week in 8 patients, and within 3
weeks in another 7 patients.
Patients and carers were able to
change the dressings themselves.
Limitations: small, uncontrolled study
The study reported 0% moist
0
desquamation rates for the Mepitel®
covered areas and 26% for the
control areas (p<0.0001).
Mepitel® film significantly decreased
the combined, researcher and
patients RISRAS
scores (p < 0.0001) by 92%
(compared with the Aqueous cream
BP areas). The majority of patients
(n=55) preferred Mepitel® film to
cream because it felt comfortable
and protective.
Limitations: as with other ‘within
patient’ trials, it was impossible to
blind the trial.
Non adhesive
Silver clear
nylon dressing
(SCND)
Randomised controlled trial –
Phase III study comparing silver
clear nylon dressing with
sulfadiazine cream in patients
with rectal or anal cancer
receiving external beam RT at
the point grade 1dermatitis
became present.
N = 40
Outcome: skin toxicity on final
day of treatment
Niazi, T., Vuong, T.,
Azoulay, L., Marijnen, C.,
Bujko, K., Nasr, E. et al.
2012. Silver clear
nylon dressing is effective
in preventing radiationinduced dermatitis in
patients with lower
gastrointestinal cancer:
results from a phase III
study. Int J Radiat Oncol
Biol Phys 1: 84:e305–e310.
Mean dermatitis score on the last
day of RT (assumed to be the point at
which skin reactions were at their
worst) was 2.53 (standard deviation
[SD], 1.17) in the standard arm and
1.67 (SD, 1.2; P=.01) in the SCND
arm. 2 weeks after RT, the difference
was 0.39 points in favour of SCND
(non-significant).
Limitations:
This was a small single blind study.
There were differences between the
histological diagnosis of the patients
and the concurrent chemo/
radiotherapy regimes. No patient
reported outcomes were used.
++