Can a difference be measured in incidence of secondary wound infection after wound cleaning with either tap water or chlorhexidin?Hypothesis: After use of tap water in wound cleaning, no difference in incidence of secondary wound infection compared…
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The endpoint of this study is the percentage wound infection after wound
treatment with stitches of tissue adhesive in the group cleaned with tap water
and in the group cleaned with chlorhexidine.
Secondary outcome
Do patients prefer cleaning with tap water or chlorhexidine?
Is wound healing different in wounds cleaned with tap water or chlorhexidine?
Is there a difference in experiencing pain between cleaning with tap water of
chlorhexidin?
Background summary
In medical practice there are several ways to desinfect wounds in order to
minimalize the chance of infection. Wounds can be desinfected with iodide,
NaCl, chlorhexidine or tapwater.
Emergency departments are being visited a lot for wounds. In the USA 7-8% of
emergency department visits exist of patients presenting with wounds. The
emergency department of the Haga Hospital is visited by 6 patients with a wound
a day. Contaminated wounds have an incidence of infection as high as 20%.
Wounds in general have 4,5-6,3% chance of infection.
At the emergency department of HAGA Hospital wounds are normally cleaned with
chlorhexidine before they are stitched or treated with tissue adhesive. But
there is reason to believe chlorhexidine can complicate wound healing by
disturbing cells that are necessary for wound healing.
Chlorhexidine is also expensive, 6 euro a liter. A bottle chlorhexidine may
only be used 24 hours after opening of the bottle.
Iodide is not an alternative, because it's disturbs neutrophil leukocytes, that
are necessary for wound healing.
An alternative for chlorhexidine could be tap water, this is easy to use and
cheaper than chlorhexidine. Tap water costs 0,00121 - 0,00210 euro a liter. Tap
water is already used as a irrigant in a lot of hospitals, for example Erasmus
MC.
A lot of studies have been performed after the use of tap water and the
incidence of wound infection, and they show tap water is a save alternative to
iodide and NaCl. Chandra Bansal investigated the difference in incidence after
wound cleaning with tap water and NaCl in children and found no significant
difference. (RR 1.07, 95% CI 0.43 to 2.64; P = 0.88)
Fernandez et al wrote a systematic review with a result that tap water might
even decreases chance of wound infection. (RR 0.55, CI 0.31 to 0.97).
Cochrane has a review called *Comparison of tap water with normal saline*, that
consists of 3 trials (Angeras 1992; Godinez 2002; Moscati 2007) that studies
stitch wounds. The group with wounds cleaned with tap water showed a
significant reduction in secondary wound infection.(RR 0.63, 95% CI 0.40 to
0.99; P = 0.05).
No comparing studies that study the outcome of desinfection with chlorhexidine
compared to tap water have been found. Also we haven't been able to find a
study that supports the use of chlorhexidine. We searched PubMed, UptoDate and
The Cochrane Library.
Study objective
Can a difference be measured in incidence of secondary wound infection after
wound cleaning with either tap water or chlorhexidin?
Hypothesis: After use of tap water in wound cleaning, no difference in
incidence of secondary wound infection compared to chlorhexidin can be measured.
Secondary endpoints:
Do patients prefer cleaning with tap water or chlorhexidine?
Is wound healing different in wounds cleaned with tap water or chlorhexidine?
Is there a difference in experiencing pain between cleaning with tap water of
chlorhexidin?
Study design
Patients that are presenting themselves at the emergency department are being
asked by the triage-nurse to participate in the study and receive written
information. They can use the time in the waiting room to read the information
and decide whether or not to to give permission. If a patient declines
participation, the patient receives the usual treatment, according to the
existing wound protocol, used at the surgery department. This means wounds of
these patients are cleaned with chlorhexidin.
If the patient does give permission, the wound is being cleaned in the way
according to the randomization, before it is being closed with tissue adhesive
or stitches. If the patient needs stitching, the wound is as usual being
anaesthetized with lidocain 1%. The wound is being stitched while the doctor is
wearing non-sterile gloves and with a disposable sterile suturing material.
The patient gets an appointment to remove the stitches and to check the wound
for infection. In general this appointment will be 7 days after stitching of
the wound. Depending on the availability of researcher and patient this varies
from 6-8 days after stitching depending on localization of the wound. The
patient can bring the information letter which holds the researchers contact
information, to enable the patient to contact the researcher in case of
questions or if there's any doubt about occurring infection. The general
practitioner will be called and informed about participation. 7 days after
stitching the stiches will be removed in a room on the emergency department and
will be checked for infection.
Patients medical file will be used to collect characteristics of the wound,
such as time passed between occurring of the wound and treatment, and the kind
of injury. Patients will be asked to number the pain during treatment, this is
the painscore.The patient has to give a number between 1 to 10, 1 is no pain at
all and 10 is the most severe pain ever. This system will be explained to the
patient. The researcher will write the number on the checklist. It will be
written down whether the woundborders are closed. Also the patient will be
asked whether he or she had a preference for treatment with chlorhexidine or
tapwater. This data will be written on a specially designed checklist.
Also a picture will be taken of all wounds, which doctor A.E. Hoek will take a
look at in order to speak out a second opinion. When there is a discrepancy
between the first finding by the researcher and the judgement of dr. Hoek, a
third doctor will be asked for his/her opinion. The third doctor will be the
attending Emergency Physician. If the opinion of the attending Emergy Physician
is that there infection has occurred and so antibiotics have to be prescribed,
the patient will be called immediately.
In case of infection the Emergency Physician will be asked to take a look at
the wound in order to prescribe antibiotics.
During wound check there will be asked if there have been signs of infection
earlier that week, and if the patient has seen his general practitioner. If
that's the case, there will be asked permission to contact the general
practitioner to collect data.
Infection is the contamination of tissue with parasites, fungi, bacterias of
viruses. Patients in this study could get a local infection at the site of the
wound. I will check for the following characteristics of infection:
Tumor or swelling,
Rubor or redness,
Dolor or pain,
Calor or warmth,
Functio laesa or loss of function,
Pus or abscess
The wound is being categorized in one of the following 4 categories.
0 = No signs of inflammation.
1 = The wound shows signs of inflammation, showing normal physiological
healing: redness <4mm from woundborder, swelling not crossing the physiologic
redness, pain not increased compared to at presentation, warmth not crossing
the physiological redness, loss of function not increased compared to
presentation, no matter in what combination, and therefore needs no treatment.
2 = The wound shows signs of infection redness >4mm from woundborder, swelling
crossing the physiologic redness, pain increased compared to at presentation,
warmth crossing the physiological redness, loss of function increased compared
to presentation and therefore needs treatment. One sign or a combination of
more signs is considered an infection.
3 = The wound has pus or abcesses and needs treatment.
Categories 2 and 3 will be considered secondary infection.
Intervention
Instead of wound cleaning with chlorhexidine, the wound will be irrigated with
tap water that is being sucked into a sterile syringe.
Study burden and risks
Burden is minimal and exists of an appointment in the hospital to remove
stitched and/or wound inspection.
Leyweg 275
Den Haag 2545CH
NL
Leyweg 275
Den Haag 2545CH
NL
Listed location countries
Age
Inclusion criteria
Patients aged 18 years and older.
Patients attending the emergency department of the Haga Hospital with a skin laceration that requires tissue adhesives or sutures.
Patients that are able to visit the Haga Hospital 6-8 days after primary visit for wound inspection.
Patients do speak Dutch
Exclusion criteria
Patients aged under 18 years.
Patients with hypersensitivity to chlorhexidine.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | EUCTR2011-002670-24-NL |
CCMO | NL36661.098.11 |