Surgical Site InfectionsNCT02619773
Effect of Mupirocin Dressings Versus Island Dressings on Surgical Site Infections in Elective Colorectal Surgery
A study testing mupirocin ointment in people with Surgical Site Infections, run by Gundersen Lutheran Medical Foundation at 1 site in United States.
Trial summary
Infections at the site of surgical incisions (SSIs) are the most common infection among surgical patients. Although all patients undergoing surgical procedures are at risk for developing SSIs, colorectal surgery has had consistently had high rates of SSIs, ranging from 3-45%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infections
- What is being tested?
- mupirocin ointment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Dec 2018
- 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
- 18 years of age or older
- Elective Colorectal surgery
- Open and minimally invasive cases
- Partial and total Colon resections, Abdominoperineal resection, Low anterior resections, Creation/takedown of colostomy, abdominal procedures for prolapse
Who cannot join
- Patients with known allergies to mupirocin
- Cases in which the skin was intentionally left open at the end of surgery (secondary closure technique)
- Women who are pregnant or planning to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Gundersen Lutheran Health System
La Crosse, Wisconsin, 54601
About this study
Official title: The Use of Mupirocin Dressings and Its Effect on Surgical Site Infections in Elective Colorectal Surgery: A Prospective, Randomized Controlled Trial
Infections at the site of surgical incisions (SSIs) are the most common infection among surgical patients. Although all patients undergoing surgical procedures are at risk for developing SSIs, colorectal surgery has had consistently had high rates of SSIs, ranging from 3-45%. These infections can increase the length of hospital stay, and increase the rate of readmissions and costs.
Further research is needed to study the effects of mupirocin in general surgery. A recent study compared colorectal SSI rates between mupirocin and standard gauze surgical dressings. The results of this show that mupirocin has the greatest effect on reducing SSI rate when compared to standard gauze dressings. However, these studies have not been performed in the United States and have only been studied on a very specific patient population.
The purpose of this study is to assess the rate of infections at the surgical incision after colorectal surgery when a mupirocin dressing is placed versus a standard gauze dressing without mupirocin.
Read the detailed description
Surgical site infections (SSIs) are the most common nosocomial infection among surgical patients and are the third most common nosocomial infection among all hospitalized patients.1 Although all patients undergoing surgical procedures are at risk for developing SSIs, colorectal surgery has consistently had high rates of surgical site infections, ranging from 3-45%. Numerous studies have shown the adverse effects of SSIs, including increased length of hospital stay, morbidity, mortality, readmissions and costs. In a recent study analyzing various surgical procedures, including colorectal operations, surgical site infection was found to be the number one cause of unplanned readmission.
Studies have been performed showing that intranasal mupirocin may have a role in reduction of SSI in cardiac and orthopedic surgery. However, there has been minimal investigation on the effects of topical mupirocin in general surgery. A recent study from Spain compared colorectal SSI rates between mupirocin dressings, silver-impregnated dressings, and standard gauze surgical dressings. The results of this show that mupirocin has the greatest effect on reducing SSI rate when compared to standard gauze and silver-impregnated dressings. However, these studies have not been performed in the United States and have only been studied on open, colorectal oncologic surgery.
The aim of this study is to compare mupirocin dressings to standard surgical dressings and their respective SSI rates at a United States community hospital in patients undergoing elective open and minimally invasive colorectal surgery.
A single-center prospective, randomized study will be performed. Patients who will undergo elective colorectal surgery and consent to participate will be randomized (1:1) to one of the following 2 treatment groups:
- Island dressings until postoperative day (POD) #2 (which is current practice at Gundersen Health System)
- Mupirocin + island dressing until POD#5 Analysis of outcomes will include rate of SSI, and 30-day morbidity and mortality.
- Conditions
- Surgical Site Infections
- Being tested
- mupirocin ointment
- Keywords
- 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.
mupirocin ointmentProcedure or surgery
Mupirocin ointment will be applied after skin closure. A standard island dressing will be placed over the incision.
| Study group | Role | What they receive |
|---|---|---|
| Mupirocin dressing | Experimental | Mupirocin + island dressing applied to surgical incision until postoperative day 5.
Intervention: mupirocin ointment applied to extrication incision. Receives: Procedure: mupirocin ointment |
| Island dressing | No intervention | Island dressing applied to surgical incision until postoperative day 2. This arm will not undergo any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection
Surgical site infection defined per ACS NSQIP criteria
Measured: within 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gundersen Lutheran Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Gundersen Lutheran Health System
- Responsible party
- Principal investigator, Kara Kallies, Gundersen Lutheran Medical Foundation
- Investigators
- Stephen B Shapiro, MD, Principal investigator, Gundersen Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619773
- Sponsor's protocol ID
- 2-15-10-001
- Status last verified
- Jan 2019
- First submitted
- 30 Nov 2015
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Mupirocin Dressings and Its Effect on Surgical Site Infections in Elective Colorectal Surgery: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02619773
- Acronym / sponsor ID
- 2-15-10-001
- Conditions
- Surgical Site Infections
- Keywords
- Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Gundersen Lutheran Medical FoundationUniversity, hospital or other
- Collaborators
- Gundersen Lutheran Health System
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 2 Dec 2015 (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.
Infections at the site of surgical incisions (SSIs) are the most common infection among surgical patients. Although all patients undergoing surgical procedures are at risk for developing SSIs, colorectal surgery has had consistently had high rates of SSIs, ranging from 3-45%. These infections can increase the length of hospital stay, and increase the rate of readmissions and costs.
Further research is needed to study the effects of mupirocin in general surgery. A recent study compared colorectal SSI rates between mupirocin and standard gauze surgical dressings. The results of this show that mupirocin has the greatest effect on reducing SSI rate when compared to standard gauze dressings. However, these studies have not been performed in the United States and have only been studied on a very specific patient population.
The purpose of this study is to assess the rate of infections at the surgical incision after colorectal surgery when a mupirocin dressing is placed versus a standard gauze dressing without mupirocin.
Detailed description
Surgical site infections (SSIs) are the most common nosocomial infection among surgical patients and are the third most common nosocomial infection among all hospitalized patients.1 Although all patients undergoing surgical procedures are at risk for developing SSIs, colorectal surgery has consistently had high rates of surgical site infections, ranging from 3-45%. Numerous studies have shown the adverse effects of SSIs, including increased length of hospital stay, morbidity, mortality, readmissions and costs. In a recent study analyzing various surgical procedures, including colorectal operations, surgical site infection was found to be the number one cause of unplanned readmission.
Studies have been performed showing that intranasal mupirocin may have a role in reduction of SSI in cardiac and orthopedic surgery. However, there has been minimal investigation on the effects of topical mupirocin in general surgery. A recent study from Spain compared colorectal SSI rates between mupirocin dressings, silver-impregnated dressings, and standard gauze surgical dressings. The results of this show that mupirocin has the greatest effect on reducing SSI rate when compared to standard gauze and silver-impregnated dressings. However, these studies have not been performed in the United States and have only been studied on open, colorectal oncologic surgery.
The aim of this study is to compare mupirocin dressings to standard surgical dressings and their respective SSI rates at a United States community hospital in patients undergoing elective open and minimally invasive colorectal surgery.
A single-center prospective, randomized study will be performed. Patients who will undergo elective colorectal surgery and consent to participate will be randomized (1:1) to one of the following 2 treatment groups:
- Island dressings until postoperative day (POD) #2 (which is current practice at Gundersen Health System)
- Mupirocin + island dressing until POD#5 Analysis of outcomes will include rate of SSI, and 30-day morbidity and mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mupirocin dressing | Experimental | Procedure: mupirocin ointmentMupirocin + island dressing applied to surgical incision until postoperative day 5. Intervention: mupirocin ointment applied to extrication incision. |
| Island dressing | No intervention | –Island dressing applied to surgical incision until postoperative day 2. This arm will not undergo any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Elective Colorectal surgery
- Open and minimally invasive cases
- Partial and total Colon resections, Abdominoperineal resection, Low anterior resections, Creation/takedown of colostomy, abdominal procedures for prolapse
Key exclusion criteria (3 listed)
- Patients with known allergies to mupirocin
- Cases in which the skin was intentionally left open at the end of surgery (secondary closure technique)
- Women who are pregnant or planning to become pregnant
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 |
|---|---|---|
| mupirocin ointmentMupirocin ointment will be applied after skin closure. A standard island dressing will be placed over the incision. | Procedure or surgery | Mupirocin dressing |
Primary outcome
Surgical Site Infection
Time frame: within 30 days postoperative
Surgical site infection defined per ACS NSQIP criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
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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.
Stephen B Shapiro, MD principal investigator
Gundersen Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mupirocin ointment in people with Surgical Site Infections, run by Gundersen Lutheran Medical Foundation at 1 site in United States.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (time frame: within 30 days postoperative). 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 8 Jan 2019.