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

Colorectal Surgery Clinical Trial

Official title:

Prospective and Comparative Pilot Study Between Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02143336
• Other study ID #: HULP-3961
• Status: Recruiting
• Phase: N/A
• First received: May 17, 2014
• Last updated: May 20, 2014
• Start date: September 2013

Study information

• Verified date: May 2014
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Ines Rubio Perez, MD
• Email: dr.inesrubio[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Surgery
• Communicable Diseases
• Infection
• Surgical Wound Infection
• Surgical Wound Infections
• Wound Infection

Intervention

Procedure:
• subcuticular suture

• Skin staples

Locations

Country	Name	City	State
Spain	Hospital Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario La Paz	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz	Surgical Infection Society Europe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of surgical site infection	The primary endpoint is the incidence of wound infection, measured from the moment of surgery up to 30 days postoperatively.	30 days, as by CDC definition	No
Secondary	prolongation of hospitalization	Length of hospital stay, and if it is prolonged as a consequence of infection	30 days	No

External Links

•   Surgical Infection Society Europe, main webpage