Postoperative negative pressure incision therapy following open colorectal surgery: a randomized-controlled trial
Not Applicable
Recruiting
- Conditions
- open colorectal surgery
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 340
Inclusion Criteria
1.) Planned elective open colorectal surgery via median or transverse laparotomy
2.) Age 18 years or older
3.) Ability to understand the nature and extend of the trial and to sign the written informed consent.
Exclusion Criteria
1.) Pregnancy or breast-feeding
2.) Median or transverse laparotomy within the last 60 days prior to inclusion into the study.
3.) Planned relaparotomy within 30 days
4.) Laparoscopic or laparoscopic assissted surgery
5.) Patients on preoperative antibiotic treatment
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of surgical site infections according to the definition of the Centers for Disease Control and Prevention within 30 days postoperative.
- Secondary Outcome Measures
Name Time Method 1.) Length of hospital stay<br>2.) Rate of reoperations<br>3.) Rate of antibiotic theray<br>4.) Duration of postoperative negative pressure incision therapy (intervention arm only)<br>5.) Wound pain assessed with visual analogue scale<br>6.) Rate of wound complications other than wound infections<br>7.) Rate of serious adverse events