T81.4
Conditions
Interventions
Group 1: Control Group: Closure of skin using transcutaneous ski staples
Group 2: Interventiongroup: Closure of skin using intracutaneous suture
Sponsors
Klinik für Viszeral-, Thorax- und Gefäßchirurgie
Universitätsklinikum Gießen und Marburg- Standort Marburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients scheduled for any elective abdominal surgery requiring midline or horizontal laparotomy, Age greater than 18 years; Expectancy of life greater than 12 months; Informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria are: date of admission exceeding four days prior to surgery, any antibiotic therapy within the 14 days prior to surgery, any previous midline or horizontal laparotomy if the procedure requires the same skin incision as before, neurophysiological or psychological deficiencies, participation in any other interventional trial that potentially interferes with the intervention or the results of the present trail, inability to understand the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurence of superficial surgical site infections is measured within 30 days after elective abdominal surgeries. Superficial surgical site infections are defined as category A1 according to the international CDC-classification. A1 infection are characterized by: Infection of the incision within 30 days after surgery, involving skin and subcutaneous tissue only and meeting one oft he following criteria: -Purulent secretion, cultural proof of bacteria derived from the tissue covering the incision or any secretion from the incision -One of the following clinical signs: pain or tenderness, swelling, redness, warmth -Opening of the wound by the treating surgeon -Diagnosed by the treating medical doctor On the days 2, 5, 10 and 30 after the elective operation Follow-Up visits are done and all wound are assessed according to the above named A1-criteria. Further, the extent of any antibiotic therapy is recorded (day 10). Patients with wound infections involving the abdominal wall or the itraabdominal cavity (CDC-Category A2 and A3) are treated as drop-outs and are excluded from the study since category A2 and A3 infections are unlikely to be associated with the examined procedures for skin closure. | — |
Secondary
| Measure | Time frame |
|---|---|
| The total operation time and the time of skin closure is measured during the operation. On day 30 after surgery, the cosmetic outcome is assessed on a subjective and objective basis on day 30 after surgery. A comprehensive self-explaining score accordingly to the German school note system ranging from 1-6 is used. Scoring is defined as follows: 1: very well, 2: good, 3: satisfactory, 4: unsatisfactory, 5: insufficient, 6: poor The subjective assessment is done by the patient using a self-explaining questionnaire. The objective assessment is done by an independent clinical expert separately. Moreover, the length of hospital stay and the duration of employees` illness are summoned and recorded in days on day 30 after surgery. | — |
Countries
Germany
Contacts
Public ContactElisabeth Maurer
Klinik für Viszeral-, Thorax- und Gefäßchirurgie Universitätsklinikum Gießen und Marburg GmbH- Standort Marburg
Outcome results
None listed