Surgical Wound InfectionsNCT02143336
Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients
A study testing subcuticular suture and Skin staples in people with Surgical Wound Infections and Colorectal Surgery, run by Instituto de Investigación Hospital Universitario La Paz at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infections, Colorectal Surgery
- What is being tested?
- subcuticular suture and Skin staples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Ines Rubio Perez, MD contact
Spain2 sites, 2 recruiting
- Recruiting
Hospital Fundacion Jimenez Diaz
Madrid, Madrid, 28040
Ignacio Valverde, PhD, ivalverden@fjd.es
Hector Guadalajara, PhD
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Ines Rubio-Perez, MD, dr.inesrubio@gmail.com
Miguel Leon Arellano, Resident
About this study
Official title: Prospective and Comparative Pilot Study Between Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients.
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.
Read the 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)
- Conditions
- Surgical Wound Infections, Colorectal Surgery
- Being tested
- subcuticular suture, Skin staples
- Keywords
- Surgical site infections, Skin closure techniques, Colorectal surgery
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcuticular sutureProcedure or surgery
Also called undyed Monocryl 4-0 (Ethicon)
Skin staplesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Subcuticular suture | Experimental | Subcuticular suture (absorbable) for skin closure Receives: Procedure: subcuticular suture |
| Skin staples | Active comparator | Standard skin staples for wound closure Receives: Procedure: Skin staples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days, as by CDC definition
Secondary outcomes (1)
prolongation of hospitalization
Length of hospital stay, and if it is prolonged as a consequence of infection
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Surgical Infection Society Europe
- Responsible party
- Sponsor
- Investigators
- Ines Rubio-Perez, MD, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143336
- Sponsor's protocol ID
- HULP-3961
- Status last verified
- May 2014
- First submitted
- 17 May 2014
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Comparative Pilot Study Between Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients.
- ClinicalTrials.gov ID
- NCT02143336
- Acronym / sponsor ID
- HULP-3961
- Conditions
- Surgical Wound Infections, Colorectal Surgery
- Keywords
- Surgical site infections, Skin closure techniques, Colorectal surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Surgical Infection Society Europe
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (estimated)
- First posted
- 21 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcuticular suture | Experimental | Procedure: subcuticular sutureSubcuticular suture (absorbable) for skin closure |
| Skin staples | Active comparator | Procedure: Skin staplesStandard skin staples for wound closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subcuticular sutureAlso: undyed Monocryl 4-0 (Ethicon) | Procedure or surgery | Subcuticular suture |
| Skin staples | Procedure or surgery | Skin staples |
Primary outcome
incidence of surgical site infection
Time frame: 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.
1 secondary outcome
prolongation of hospitalization
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
- Surgical Infection Society Europe, main webpageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ines Rubio Perez, MD contact
Ines Rubio-Perez, MD principal investigator
Hospital Universitario La Paz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subcuticular suture and Skin staples in people with Surgical Wound Infections and Colorectal Surgery, run by Instituto de Investigación Hospital Universitario La Paz at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ines Rubio Perez, MD (dr.inesrubio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of surgical site infection (time frame: 30 days, as by CDC definition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2014.