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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

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.

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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)

Conditions

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Surgical Wound Infections Colorectal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Subcuticular suture

Subcuticular suture (absorbable) for skin closure

Group Type EXPERIMENTAL

subcuticular suture

Intervention Type PROCEDURE

Skin staples

Standard skin staples for wound closure

Group Type ACTIVE_COMPARATOR

Skin staples

Intervention Type PROCEDURE

Interventions

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subcuticular suture

Intervention Type PROCEDURE

Skin staples

Intervention Type PROCEDURE

Other Intervention Names

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undyed Monocryl 4-0 (Ethicon)

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No