NCT02143336

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

May 21, 2014

Status Verified

May 1, 2014

Enrollment Period

2 years

First QC Date

May 17, 2014

Last Update Submit

May 20, 2014

Conditions

Surgical Wound InfectionsColorectal Surgery

Keywords

Surgical site infectionsSkin closure techniquesColorectal surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • prolongation of hospitalization

    30 days

Study Arms (2)

Subcuticular suture

EXPERIMENTAL

Subcuticular suture (absorbable) for skin closure

Procedure: subcuticular suture

Skin staples

ACTIVE COMPARATOR

Standard skin staples for wound closure

Procedure: Skin staples

Interventions

subcuticular suturePROCEDURE
Also known as: undyed Monocryl 4-0 (Ethicon)
Subcuticular suture
Skin staplesPROCEDURE
Skin staples

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Fundacion Jimenez Diaz

Madrid, Madrid, 28040, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Related Links

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ines Rubio-Perez, MD

    Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ines Rubio Perez, MD

CONTACT

dr.inesrubio@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2014

First Posted

May 21, 2014

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Last Updated

May 21, 2014

Record last verified: 2014-05

Locations

ES(2)