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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Surgical Wound Infections, Colorectal Surgery

Intervention / Treatment
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* Procedure: subcuticular suture
* Procedure: Skin staples


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subcuticular suture<br>Subcuticular suture (absorbable) for skin closure | Procedure: subcuticular suture<br> <br> * Other names: undyed Monocryl 4-0 (Ethicon);|
| Active Comparator: Skin staples<br>Standard skin staples for wound closure | Procedure: Skin staples<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical site infections, Skin closure techniques, Colorectal surgery