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

Instituto de Investigación Hospital Universitario La Paz

Status: Unknown

Conditions: Surgical Wound Infections; Colorectal Surgery

Treatments: Procedure: subcuticular suture; Procedure: Skin staples

Study type: Interventional

Funder types: Other

Identifiers

NCT02143336

HULP-3961

Details and patient eligibility

About

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.

Full 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)

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 2 patient groups

Subcuticular suture

Experimental group

Description:

Subcuticular suture (absorbable) for skin closure

Treatment:

Procedure: subcuticular suture

Skin staples

Active Comparator group

Description:

Standard skin staples for wound closure

Treatment:

Procedure: Skin staples