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Chlorhexidine-alcohol versus iodine-alcohol for surgical-site antisepsis


- candidate number14908
- NTR NumberNTR4004
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-mei-2013
- Secondary IDs12-206 METC nummer
- Public TitleChlorhexidine-alcohol versus iodine-alcohol for surgical-site antisepsis
- Scientific TitleA PRAGMATIC MULTICENTER CLUSTER RANDOMISED CROSS-OVER TRIAL COMPARING CHLORHEXIDINEALCOHOL AND IODINE-ALCOHOL FOR SURGICAL-SITE ANTISEPSIS
- ACRONYMSKINFECT
- hypothesisTo investigate whether either chlorhexidine-alcohol or iodine-alcohol based skin antiseptics is more protective against surgical site infections.
- Healt Condition(s) or Problem(s) studiedPostoperative inflammation
- Inclusion criteriaAll patients undergoing general surgical and/or orthopedic indicator operations that are reported to Prezies-network.
- Exclusion criteria- Inability to complete 30 days follow-up;
- < 18 years of age;
- Evidence of infection at or adjacent to the operative site;
- History of allergy for chlorhexidine, alcohol or idiophors.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-jul-2013
- planned closingdate1-aug-2015
- Target number of participants4000
- InterventionsParticipating hospitals are randomly assigned to either chlorhexidine-alcohol (0.5% chlorhexidine in alcohol 70%) or iodine-alcohol (1% iodine in alcohol 70%) for preoperative skin antisepsis for a time period of three months. After the first period of three months, centers will switch to using the other agent for preoperative antisepsis. Centers will switch each 3 months for 3 times and will actively be contacted two weeks before a switch will take place. Patients will undergo routine surgical care and after care. The surgical site will be assessed regularly during hospitalization, on discharge, at the time of follow-up evaluation, and whenever SSI occurs.
- Primary outcomePrimary endpoint is the occurrence of SSI within 30 days following surgery or within one year following orthopaedic procedures.
- Secondary outcomeSecondary endpoints are variations in SSI between indicator operations, wound classification and wound type.
- TimepointsSurgical-site infection data will be recorded postoperatively and sent to the PREZIES network. The rate of surgical-site infection will be evaluated 30 days after patient accrual has stopped. Furthermore, all cases with implants will be evaluated for surgical-site infections one year from the end of the study.
- Trial web sitewww.skinfect.org
- statusplanned
- CONTACT FOR PUBLIC QUERIES Charehbili
- CONTACT for SCIENTIFIC QUERIES R.J. Swijnenburg
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- Publications
- Brief summaryRationale: Surgical-site infection (SSI) increases morbidity, mortality, length of hospital stay and costs. Optimization of preoperative skin antisepsis may decrease postoperative infections. In the Netherlands, chlorhexidine-alcohol and iodine-alcohol based skin antiseptics are currently used at random in general surgery mostly depending on local or personal preferences. Objective: To investigate whether either chlorhexidine-alcohol or iodine-alcohol based skin antiseptics is more protective against surgical site infections.
Study design: A prospective pragmatic cluster randomised cross-over trial Study population: Patients > 18 years of age undergoing general-surgical and/or orthopaedic indicator operations. Intervention (if applicable): Participating hospitals are randomly assigned to an alternating schedule of either chlorhexidine-alcohol (A) or iodine-alcohol (B) for preoperative skin antisepsis for a time period of three months. After each period of three months for a total study period of one year, hospitals will cross over, resulting in intervention schedules of either ABAB or BABA.
Main study parameters/endpoints: Primary endpoint: Wound infection within 30 days after surgery, or 1 year after surgery with a non-humane implant. Secondary endpoints: (1) Type of wound infection, (2) Opened wounds (3) microbiologic causes of infection, (4) adverse events Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Preoperative evaluation will include a routine medical history, taking psychical examination, and hematologic and blood chemical laboratory tests.
According to the hospitals assigned cluster, the participant will be subject to painting of the skin with either chlorhexidine-alcohol or iodine-alcohol immediately prior to surgery. Both investigational products have been used for decades for surgical site antisepsis and are considered safe. Minimal side effects have been reported. Participants will undergo routine surgical care and after care. The surgical site will be assessed during hospitalization, on discharge, at the time of follow-up evaluation, and whenever SSI occurs. If SSI is suspected or diagnosed, clinically relevant microbiologic samples will SKINFECT Trial, version 2.1 24-10-2012 3 be cultured. At 30 days follow-up (or 1 year follow up in case of surgery with non-human implants), SSI data, collected by PREZIES network, will be analysed.
- Main changes (audit trail)
- RECORD21-mei-2013 - 25-jun-2014


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