Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients

Not Applicable

• Conditions: Surgical Wound Infections; Colorectal Surgery
• Interventions: Procedure: Skin staples; Procedure: subcuticular suture

• Registration Number: NCT02143336
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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)

Study Timeline

• Study Start: 2013-09
• Status Verified: 2014-05
• Study First Submitted: 2014-05-17
• Study First Submitted QC: 2014-05-20
• Last Update Submitted: 2014-05-20
• Study First Posted: 2014-05-21
• Last Update Posted: 2014-05-21
• Primary Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skin staples	Skin staples	Standard skin staples for wound closure
Subcuticular suture	subcuticular suture	Subcuticular suture (absorbable) for skin closure

Primary Outcome Measures

Name	Time	Method
incidence of surgical site infection	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 Outcome Measures

Name	Time	Method
prolongation of hospitalization	30 days	Length of hospital stay, and if it is prolonged as a consequence of infection

Trial Locations

Locations (2)

Hospital Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain