Clinical trial NCT02143336: Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients
Official title: Prospective and Comparative Pilot Study Between Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Wound Infections
Colorectal Surgery
Keywords: Surgical site infections
Skin closure techniques
Colorectal surgery
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Surgical Infection Society Europe
First posted: 2014-05-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)

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

Primary outcomes:
measure: incidence of surgical site infection
timeFrame: 30 days, as by CDC definition
Secondary outcomes:
measure: prolongation of hospitalization
timeFrame: 30 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario La Paz
name: Ines Rubio-Perez, MD
role: PRINCIPAL_INVESTIGATOR
References: