Prospective and Comparative Pilot Study Between Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Surgical Wound Infections
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- incidence of surgical site infection
- Last Updated
- 11 years ago
Overview
Brief Summary
A comparison of skin closure techniques (standard skin closure with staples versus a continuous (subcuticular) absorbable suture), to determine if this changes the rate of post operative wound infections in elective colorectal surgery patients.
Detailed Description
In colorectal surgery, there has been a growing interest in the study of Surgical Site Infections (SSI), with an outstanding variability of reported incidence, ranging from 3% up to 30% depending on the series. Although general risk factors for infection have been identified, there is still a need to identify specific risk factors for colorectal surgery patients, to try to reduce these numbers. The technique and materials used for wound closure have been considered as interesting variables for study. Main question of our study: is subcuticular (reabsorbable, continuous) suture better than skin staples for reducing wound SSIs in colorectal surgery? The study is sponsored by the Surgical Infection Society Europe, and was awarded the SIS-E Fellowship for young investigators (2013)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults (age \>18), both genders.
- •Elective colorectal surgery interventions
- •Open surgery incisions and laparoscopic extraction incisions
- •Incisions \>5cm, any location
- •Intervention performed by a specialist colorectal surgeon
- •Patient suitable for surgery in preoperative assessment
- •Informed consent
Exclusion Criteria
- •Emergency colorectal surgery
- •Scheduled multiple surgical procedures
- •Unsuitable preoperative assessment
- •Other infections present/being treated.
- •Incorrect application of standard surgical infection prevention measures (antibiotic prophylaxis, antibiotic treatment prior to surgery, intraoperative heat/O2/glycemic control,etc.)
- •Inability to understand the study/sign informed consent
Outcomes
Primary Outcomes
incidence of surgical site infection
Time Frame: 30 days, as by CDC definition
The primary endpoint is the incidence of wound infection, measured from the moment of surgery up to 30 days postoperatively.
Secondary Outcomes
- prolongation of hospitalization(30 days)