Surgical Wound Infection
Conditions
Brief summary
This study is to evaluate the effectiveness of the plastic ring wound retractor to reduce the rate of surgical site infection in patients who undergo open abdomen surgery for gastrointestinal tract.
Detailed description
Participants who are determined to undergo open abdomen surgery will be screening for the eligibility first. If eligible and agreed to participate, each participant will be assigned to either the experimental group or control group based on the electronic randomization. The experimental group will use the plastic ring wound retractor, while the control group will use a conventional surgical pad for wound protection method. Each participant will be blind to the randomization result because he/she will be under general anesthesia. Once the surgery is finished, the patient will be assessed on the surgical wound at postoperative day 1, 7, 14, 30. Two groups will be compared for the surgical wound infection rate.
Interventions
DEVICEuse of plastic ring wound retractor
the experimental arm will use the plastic ring wound retractor for wound protection.
Sponsors
Saint Vincent's Hospital, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Each participant will be under the general anesthesia without knowing which group is assigned to.
Intervention model description
The experimental group will be using the plastic wound retractor, while the control group will use a conventional surgical pad for wound protection.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* age older than 18 years or less than 75 years * either elective or emergent surgery for upper GI, small intestine, or colorectal disease * open laparotomy * the patient who agrees to participate in this trial
Exclusion criteria
* concurrent abdominal wall infection * open conversion from laparoscopy * poor nutritional status, NRS 2002 score 3 * combined hepatobiliary operation * pregnant or breast-feeding state * severe immunosuppression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of surgical wound infection | within 30 days postoperative | The rate of surgical wound infection will be monitored for each group. |
Countries
South Korea
Outcome results
None listed