|- candidate number||13115|
|- NTR Number||NTR3541|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-jul-2012|
|- Secondary IDs||2011-306 / NL34798.078.11; METC ErasmusMC / CCMO|
|- Public Title||Sterile versus clean suturing of traumatic wounds.|
|- Scientific Title||Traumatic wounds; sterile versus clean suturing.|
|- hypothesis||The incidence and types of infection are comparable in sterile suturing or clean suturing of traumatic wounds.
Clean suturing is cheaper, less time consuming and requires less assistence that sterile suturing|
|- Healt Condition(s) or Problem(s) studied||Wound, Suturing, Sterile, Emergency department|
|- Inclusion criteria||1. ED presentation with traumatic suturing wound;|
2. Age 18 years and older;
3. Informed consent.
|- Exclusion criteria||1. Complicated wound: bitewound, vascular, tendon, nerve, ossale, cartilage injury;|
2. Direct other intervention needed;
3. Treatment by doctor of orther speciality then emergengy medicine or surgery;
4. Signs of infection on ED presentation;
5. Wound older then 24 hours.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2012|
|- planned closingdate||1-aug-2015|
|- Target number of participants||2140|
|- Interventions||(Control) sterile suturing or (intervention) clean suturing.
Sterile suturing will be done with sterile gloves, sterile gauzes and sterile coveringcloth.
Clean suturing wil be done with clean boxed gloves, clean gauzes and without a covering cloth.
For both procedures, usage of extra materials and assistence will be documented.
All patients will return in after 5 to 14 days to the Emergency Department for suture removal and wound assesment.
|- 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||1. Are there any factors influencing the development of wound infection in both groups?|
2. Is there a difference in costs and the need for assistence between both groups?
|- Timepoints||1. Woundinfection developping between suturing and suture removal (5-14 days);|
2. Costs during intervention (day 1);
3. Need for assistence during intervention (day 1).
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| J.J.M. Zwaans|
|- CONTACT for SCIENTIFIC QUERIES|| J.J.M. Zwaans|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center|
|- Brief summary||The aim of this study is to find out if sterile and clean suturing of traumatic wounds in the Emergency Department are comparable looking at wound infection. Secondary we want to find out if clean suturing is cheaper, less time consuming and requires less assistence comparing with sterile suturing of traumatic wounds.|
|- Main changes (audit trail)|
|- RECORD||9-jul-2012 - 13-aug-2012|