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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02143336

Enrollment

400

Registered

2014-05-21

Start date

2013-09-30

Completion date

Unknown

Last updated

2014-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Surgery, Surgical Wound Infections

Keywords

Surgical site infections, Skin closure techniques, Colorectal surgery

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)

Interventions

PROCEDUREsubcuticular suture

PROCEDURESkin staples

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
prolongation of hospitalization	30 days	Length of hospital stay, and if it is prolonged as a consequence of infection

Countries

Spain

Contacts

Primary ContactInes Rubio Perez, MD

dr.inesrubio@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026