Correcting the causative factors of intertrigo is critical. Take steps to eliminate friction, heat, and maceration by keeping folds cool and dry. The goals of pharmacotherapy for intertrigo are to reduce morbidity and to prevent complications. To…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effect of a barrier cream with honey and zinc oxide ointment on reducing
the irritative skindefects
Secondary outcome
Comfort of both treatments will be measured.
Background summary
Intertrigo is an inflammatory condition of skin folds, induced or aggravated by
heat, moisture, maceration, friction, and lack of air circulation. Intertrigo
frequently is worsened or colonized by infection, which most commonly is
candidal but also may be bacterial, fungal, or viral. Intertrigo commonly
affects the axilla, perineum, inframammary creases, and abdominal folds.1,2
Diaper dermatitis shows significant overlap with intertrigo. Intertrigo is a
common complication of obesity and diabetes.
Pathophysiology Intertrigo develops from mechanical factors and secondary
infection. Heat and maceration are central to the process. Opposing skin
surfaces rub against each other, causing erosions that become inflamed. Sweat,
feces, urine, and vaginal discharge may aggravate intertrigo in both adults and
infants.
Frequency International Intertrigo is common, especially in hot humid
environments. Intertrigo is a common complication of diabetes, and it affects
most infants as a component of diaper dermatitis.
Mortality/Morbidity
As a complication of more serious disease, intertrigo should be considered a
comorbidity. Intertrigo becomes most serious as a source of secondary
infection.
Age
Intertrigo affects people who are very old and very young because of reduced
immunity, immobilization, and incontinence.
Study objective
Correcting the causative factors of intertrigo is critical. Take steps to
eliminate friction, heat, and maceration by keeping folds cool and dry. The
goals of pharmacotherapy for intertrigo are to reduce morbidity and to prevent
complications. To reduce friction and protect the skin the use of a barrier
cream is often effective. Treatment of the superficial bacterial or mycologic
infection is necessary. Honey works as an antiseptic with a broad-spectrum. We
want to comare the therapeutic effect of a barrier cream with and without
honey.
Study design
Single blind randomized study, zinc oxide ointment compared to barrier cream
with honey in the treatment of intertrigo. We will be including 50 patients.
Inclusion criteria are patients with intertrigo. Exclusion criteria those
withdrawal of informed consent, with wounds and use of other barrier creams.
The zinc oxide ointment and barrier cream with honey will be applied to the
skinfolds. The effect of treatment (differences of skinfolds left-right) will
be analyzed on day 7, 14 and 21.
Study burden and risks
Topical treatment with a barrier cream is a standard therapy. We hope that the
barrier cream with honey will be easy to apply. And will be convenient for
patients and staff use. Removal of barrier cream is not necessary, in contrast
to the topical zinc oxide cream. This will lead often to inconvenience for
patients and staff.
Bolkesteinlaan 75
7416SE
NL
Bolkesteinlaan 75
7416SE
NL
Listed location countries
Age
Inclusion criteria
Patients with intertrigo
Exclusion criteria
Wounds and one sided intertrigo
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2011-001469-42-NL |
CCMO | NL35328.075.11 |