Research if the incidence and types of wound infections are comparable in the sterile versus clean wound treatment.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- the incidence of wound infections in steriel versus clean suturing procedure
of traumatic wounds in a maximum follow up period of 14 days
Secondary outcome
-Incidence of infection in subgroups
-Incidence of infection in different wound locations
-Incidence of infection in different wound types
-Incidence of infection in different time intervals between trauma and
presentation on the ED.
Background summary
In the Emergency Department (ED) traumatic wounds are very common. Of all the
traumatic wouds seen in de ED 2,4%-7% become infected. Traumatic wounds, for
example by falling in the street or a cut from a used knife, are in pricipal
contaminated. This is in contradiction to the sterile surgical wounds in the
operating theatre. Still today, despite the lack of evidence, the sterile
technique is used and recommended for the treatment of traumatic wounds in the
ED. Also in the Erasmus Medical Centre, Rotterdam and Sint Franciscus Gasthuis,
Rotterdam the sterile technique is used. For suturing of traumatic wounds
sterile gloves, gauzes, cloths and suturing materials are used.
In contrast to this Dutch General Practicioners suture using a partially or
completely nonsterile technique and there are several hospitals in the
Netherlands (e.g. Haga Hospital and Atrium Hospital) that, based on research,
no longer use the sterile technique.
Strict sterile suturing is costly, frequently requires extra assistance and is
more time consuming compaired to clean suturing. Also the sterile field is hard
to maintain because of patient movements, reaching for materials by the docto
and other situations in the ED where the docter needs to postpone the suturing
and the sterile materials are left opened for al long period of time.
Presently in the literature there is only one study (Perelman et al. Ann Emerg
Med. 2004;43:362-370) which compares sterile versus clean suturing. This study
showed no significant difference in the incidence of wound infections between
wounds sutured under sterile or clean conditions.
Study objective
Research if the incidence and types of wound infections are comparable in the
sterile versus clean wound treatment.
Study design
Prospective Randomised Multicentre Controlled Trail
Based on an expected prevalence of infection of 2.4%-7% in combination with an
average of 70 wounds per month that need suturing, patients need to be
recruited for 2.5 years to reach a statistical power of 80%. All patients above
18 years of age who present with a uncomplicated traumatic wound and are
treated in the ED(by AIOS SEH/ANIOS SEH/NP'er/AIOS CHI/ANIOS CHI) will be
included in the study. All patients with complicated wounds, patients who are
not treated by an ED doctor or a surgeon or patients that can not give informed
constent will be excluded.
The attending doctor will, in the privacy of patients room, discuss the study
and information leaflet. After 30 minutes of thinking time the patient will be
asked to give informed consent to take part in the study. Following the
informed consent electronic randomisation will occur. Preparation of the wound
and setting out the suturing materials will then be carried out by the nurse.
Suturing (and when needed debridement) of the wound will then be done by the
doctor. Preparation, cleaning, aneasthesia, debridement and suturing and the
order of these actions are standardised in the sterile and clean protocol. The
protocols differ in sterile or clean gloves and gauzes and the use of sterile
cloths. After suturing the nurse will put a dressing on the wound and make an
appointment for wound follow up. This appointment will coincide with suture
removal. For this the guideline *wondbehandeling in de Eerste Hulp-afdeling* on
the Kwaliteitsinformatie systeem (KIS) of the Erasmus Medical Centre will be
used. Patients are instructed to return to the Emergency department if they see
signs of infection. Patients will receive a wound brochure to explain this
fully. The study forms will be completed by the attending docter. When besides
the standard materialparcel extra material is used this will be filled in on
the material form by the docter. During the follow up appointment the wound
will be examined by a staff Emergency Physician or a Surgeon and the wound
control form will be completed. If the patient notes that there were signs of
infection of the wound earlier, but during removal of the sutures no signs of
infection are seen, this will be considered irrelevant. If patient not attend
the follow up appointment, they will be contacted by telephone.
Intervention
Sterile versus clean suturing
Study burden and risks
No extra risks then the risks of suturing a traumatic wound
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- ED presentation with traumatic suturing wound
- Age 18 years and older
- Informed consent
Exclusion criteria
-complicated wound: bitewound, vascular, tendon and/or nerve injury, fracture/cartilage injury
-OR intervention needed
-treatment by doctor of orther speciality then emergengy medicine or surgery
-signs of infection on ED presentation
-wound older then 24 hours
Design
Recruitment
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 |
---|---|
CCMO | NL34798.078.11 |