Wound Infection
Conditions
Keywords
surgical site infection, elective colorectal surgery, level of surgical site infection, complication of surgical site infection, type of changed bandage, frequency of bandage changing
Brief summary
After open colo-rectal surgery the surgical site infection (SSI) is very high among abdominal surgeries. The goal of the investigators randomized, prospective, multicentric, internet-based study is to compare rate of SSI after surgery of colon and rectum by using triclosan-coated suture for abdominal wall closure. 180-180 cases in seven centres are involved in this study. Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus). Triclosan is an antiseptic material which the investigators hope will provide better local infection control at the site with reducing the risk of bacterial colonisation.
Detailed description
After open colo-rectal surgery the surgical site infection (SSI) is very high among abdominal surgeries. The goal of our randomized, prospective, multicentric, internet-based study is to compare rate of SSI after surgery of colon and rectum by using triclosan-coated suture for abdominal wall closure. Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus). Triclosan is an antiseptic materia which we hope provides better local infection control at the site with reducing the risk of bacterial colonisation. attached website: www.itplan.hu/sebstudy/ Randomizing patients: 1. logging in (completing the ID pannel) 2. on-line randomization 3. patient appears on list 4. operation (recording details) 5. recording - post-operation events * complications * control examination
Interventions
PROCEDUREabdominal wall closure
triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall
Sponsors
University of Pecs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Elective (subjected to bowel preparation) operations * Benign or malignsnt colon or rectal disease * Age: 18-80 * Bowel opening is made during operation
Exclusion criteria
1. Cannot be randomized: Systemic diseases influencing local surgical site healing Insulin-dependent diabetes mellitus Child B-C liver cirrhosis Kidney disease requiring dialysis Immune-suppression treatment IBD Acute surgery or unpreparated bowel After being informed patient does not sign the statement of consent 2. To be excluded later: Surgically incurable tumour Septic state or complication occurred in the post-operational stage Patient withdraws the signed consent before the examination is closed 3. Undesirable complication: Sterile surgical site separation Suture break during the post-operational stage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| quality and quantity of wound discharge | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| number of applied different types of bandages | 30 days |
| charges of wound care | 30 days |
Countries
Hungary
Outcome results
None listed