Colorectal Surgery, Wound Infections
Conditions
Keywords
colorectal surgery, wound infection, wound protector, laparoscopy, surgical site infection after laparoscopic colorectal surgery with minilaparotomy
Brief summary
Surgical site infection is common in colorectal surgery leading to increased postoperative pain, longer hospital stay, delayed wound healing and increased re-operation rates. Hence, reducing the wound infection rate is a major aim in abdominal surgery. Wound protectors were invented for retracting the abdominal wall and keeping the abdominal wall sterile in order to reduce bacterial colonialization of the wound and wound infections. This is a prospective-randomized trial comparing use of wound protectors versus woven drapes in laparoscopic colon resections with minilaparotomy.
Interventions
DEVICEwound protector
after minilaparotomy, the wound protector is applied
DEVICEno wound protector
use of woven drape instead of wound protector
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* elective laparoscopic colorectal resection with minilaparotomy
Exclusion criteria
* emergency operation * patients under 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of wound infections | 6 months postoperatively | the total percentage of wound infections within 6 months postoperatively will be analyzed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| colonialization of abdominal wall with bacteria | 6 months postoperatively | a swab of the abdominal wall is taken before skin closure routinely in every participating patient and the bacteria found is analyzed |
| postoperative costs | 6 months postoperatively | the costs for the operation, for the hospital stay including re-admissions, and for the outpatient stay is analyzed |
| length of hospital stay | 6 months postoperatively | the total hospital stay including re-admissions is analyzed |
| cosmetic result | 6 months postoperatively | the satisfaction with the cosmeti result is analyzed in every patient by questionnaire 6 months postoperatively |
Countries
Germany
Outcome results
None listed