Surgical Site Infection
Conditions
Brief summary
Wound infections are a frequent complication in abdominal surgery. The investigators hypothesize that the antiseptic solution 0.04 % polyhexanide (serasept) may reduce occurrence of postoperative wound infections compared to NaCL (saline) solution in a prospective randomized setting.
Detailed description
Invstigator initiated monocenter randomized controlled trial. Intraoperative irrigation of subcutaneous tissue with NaCl (saline) solution or antiseptic solution 0.04 % polyhexanide (Serasept) in elective abdominal surgery. Primary endpoint: SSI 30 days postoperatively according to CDC criteria.
Interventions
DRUGPolihexanide; Serasept
Experimental arm: irrigation of subcutaneous tissue after fascia closure with polihexanide (ten minutes). A single dose of perioperative antibiotics (cefuroxim alone or cefuroxim and metrodidazole in bowel surgeries) was given 30 minutes before skin incision. Hair removal was done with electronic clippers and preoperative skin antisepsis was performed with propanol and povidone-iodine. Before closure of fascia, instruments and gloves were changed. No subcutaneous suture was used. Skin was closed either with skin staples, continuous intracutaneous suture or interrupted suture. All surgeries were done according to the Standard Operating Procedures of the Department for General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin.
DRUGNaCl; saline
Control arm: irrigation of subcutaneous tissue after fascia closure with NaCl (one minute) A single dose of perioperative antibiotics (cefuroxim alone or cefuroxim and metrodidazole in bowel surgeries) was given 30 minutes before skin incision. Hair removal was done with electronic clippers and preoperative skin antisepsis was performed with propanol and povidone-iodine. All surgeries were done according to the Standard Operating Procedures of the Department for General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin. Before closure of fascia, instruments and gloves were changed. No subcutaneous suture was used. Skin was closed either with skin staples, continuous intracutaneous suture or interrupted suture. All surgeries were done according to the Standard Operating Procedures of the Department for General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin.
Sponsors
Johannes Lauscher
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Two arm prospective randomized single center interventional trial. 1:1 randomization into experimental arm (irrigation with polyhexanide) and control arm (irrigation with saline).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- planned laparotomy for visceral surgery
Exclusion criteria
* Age under 18 years * allergy against polihexanid * laparoscopic surgery * emergency surgery * lack of understanding of the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| surgical site infection | 30 days postoperatively | Surgical site infection according to CDC definition. |
Countries
Germany
Outcome results
None listed