Surgical Wound InfectionPhase 3NCT01316588
Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes
A Phase 3 study testing Plastic adesive drape and Microbial Sealant in people with Surgical Wound Infection, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
The purpose of this study is to measure the time to recolonization intraoperatively after preoperative disinfection with chlorhexidine solution in ethanol and to determine evidence of differential bacterial growth with or without plastic adhesive drape on the chest as well as with or without microbial sealant on the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Plastic adesive drape and Microbial Sealant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2010to Oct 2011
- Phase
- Phase 3
- 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
- Elective CABG and/or AVR
Who cannot join
- Suffer from any recent infection two weeks prior to the start of the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recolonization of the Skin Following Pre-operative Disinfection and Impact of the Use of Plastic Adhesive Drapes
The purpose of this study is to measure the time to recolonization intraoperatively after preoperative disinfection with chlorhexidine solution in ethanol and to determine evidence of differential bacterial growth with or without plastic adhesive drape on the chest as well as with or without microbial sealant on the leg.
Read the detailed description
The purpose of this study is to measure the time to recolonization intraoperative after preoperative disinfection with chlorhexidine solution in ethanol and to determine evidence of differential bacterial growth with or without plastic adhesive drape as well as with or without microbial sealant on the leg. A RCT study of 140 patients undergoing coronary artery bypass grafting (CABG) and/or aortic valve replacement (AVR) are included. The investigators test the hypothesis that patients randomized to no plastic adhesive drape intraoperatively will have a reduced recolonisation compared to patients with plastic adhesive drape.
- Conditions
- Surgical Wound Infection
- Being tested
- Plastic adesive drape, Microbial Sealant
- Keywords
- recolonization, Plastic adhesive drape, microbial sealant, SSI, bacterial growth
- 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.
Plastic adesive drapeOther
Plastic adhesive drape intraoperatively on patients skin around the surgical wound on the chest and bare skin on the leg
Microbial SealantOther
Microbial sealant intraoperatively on patients skin around the surgical wound on the leg and bare skin on the chest
| Study group | Role | What they receive |
|---|---|---|
| Plastic adesive drape | Experimental | Intraoperative: Plastic adhesive drape on the chest and bare skin on the leg Receives: Other: Plastic adesive drape |
| Microbial Sealant | Experimental | Intraoperative: Microbial Sealant on the leg and bare skin on the chest Receives: Other: Microbial Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial samples
Bacterial samples on the skin of the chest: one day before surgery, the day of surgery, and immediately after disinfection. Thereafter five times both on the skin and in the surgical wound i.e. 60, 120, 180 and 240 minutes intraoperatively as well as at the closure of the surgical wound.
Bacterial samples on the leg: one day before surgery, the day of surgery, and immediately after disinfection. Thereafter at two occasions both : on the skin and in the surgical wound i.e. at the incision and at the closure of the surgical wound.
Measured: Bacterial samples are taken on eight occasionson the chest and at five occations
Secondary outcomes (1)
Surgical site infection
ASEPSIS score will be measured after 2 months
Measured: once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startAug 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Region Örebro County
- Responsible party
- Principal investigator, Ulrica Nilsson, Örebro University, Sweden
- Investigators
- Ulrica Nilsson, PhD, Professor, Principal investigator, Örebro University, faculty of Medicine and Health , Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316588
- Sponsor's protocol ID
- 2010/46
- Status last verified
- Apr 2016
- First submitted
- 11 Mar 2011
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Falk-Brynhildsen K, Soderquist B, Friberg O, Nilsson U. Bacterial growth and wound infection following saphenous vein harvesting in cardiac surgery: a randomized controlled trial of the impact of microbial skin sealant. Eur J Clin Microbiol Infect Dis. 2014 Nov;33(11):1981-7. doi: 10.1007/s10096-014-2168-x. Epub 2014 Jun 8.
PubMed 24907853Falk-Brynhildsen K, Soderquist B, Friberg O, Nilsson UG. Response to M.H. Stevens and N.M. Klinger, re: Bacterial recolonization of the skin and wound contamination during cardiac surgery. J Hosp Infect. 2013 Dec;85(4):325. doi: 10.1016/j.jhin.2013.09.001. Epub 2013 Sep 17. No abstract available.
PubMed 24080082Falk-Brynhildsen K, Soderquist B, Friberg O, Nilsson UG. Bacterial recolonization of the skin and wound contamination during cardiac surgery: a randomized controlled trial of the use of plastic adhesive drape compared with bare skin. J Hosp Infect. 2013 Jun;84(2):151-8. doi: 10.1016/j.jhin.2013.02.011. Epub 2013 Apr 25.
PubMed 23623487
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recolonization of the Skin Following Pre-operative Disinfection and Impact of the Use of Plastic Adhesive Drapes
- ClinicalTrials.gov ID
- NCT01316588
- Acronym / sponsor ID
- 2010/46
- Conditions
- Surgical Wound Infection
- Keywords
- recolonization, Plastic adhesive drape, microbial sealant, SSI, bacterial growth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Region Örebro County
- Study start
- Aug 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 16 Mar 2011 (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.
The purpose of this study is to measure the time to recolonization intraoperatively after preoperative disinfection with chlorhexidine solution in ethanol and to determine evidence of differential bacterial growth with or without plastic adhesive drape on the chest as well as with or without microbial sealant on the leg.
Detailed description
The purpose of this study is to measure the time to recolonization intraoperative after preoperative disinfection with chlorhexidine solution in ethanol and to determine evidence of differential bacterial growth with or without plastic adhesive drape as well as with or without microbial sealant on the leg. A RCT study of 140 patients undergoing coronary artery bypass grafting (CABG) and/or aortic valve replacement (AVR) are included. The investigators test the hypothesis that patients randomized to no plastic adhesive drape intraoperatively will have a reduced recolonisation compared to patients with plastic adhesive drape.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plastic adesive drape | Experimental | Other: Plastic adesive drapeIntraoperative: Plastic adhesive drape on the chest and bare skin on the leg |
| Microbial Sealant | Experimental | Other: Microbial SealantIntraoperative: Microbial Sealant on the leg and bare skin on the chest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective CABG and/or AVR
Key exclusion criteria (1 listed)
- Suffer from any recent infection two weeks prior to the start of the trial
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 |
|---|---|---|
| Plastic adesive drapePlastic adhesive drape intraoperatively on patients skin around the surgical wound on the chest and bare skin on the leg | Other | Plastic adesive drape |
| Microbial SealantMicrobial sealant intraoperatively on patients skin around the surgical wound on the leg and bare skin on the chest | Other | Microbial Sealant |
Primary outcome
Bacterial samples
Time frame: Bacterial samples are taken on eight occasionson the chest and at five occations
Bacterial samples on the skin of the chest: one day before surgery, the day of surgery, and immediately after disinfection. Thereafter five times both on the skin and in the surgical wound i.e. 60, 120, 180 and 240 minutes intraoperatively as well as at the closure of the surgical wound. Bacterial samples on the leg: one day before surgery, the day of surgery, and immediately after disinfection. Thereafter at two occasions both : on the skin and in the surgical wound i.e. at the incision and at the closure of the surgical wound.
1 secondary outcome
Surgical site infection
Time frame: once
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 19 Apr 2016.
- Results publication: PubMed 24907853Falk-Brynhildsen K, Soderquist B, Friberg O, Nilsson U. Bacterial growth and wound infection following saphenous vein harvesting in cardiac surgery: a randomized controlled trial of the impact of microbial skin sealant. Eur J Clin Microbiol Infect Dis. 2014 Nov;33(11):1981-7. doi: 10.1007/s10096-014-2168-x. Epub 2014 Jun 8.
- Results publication: PubMed 24080082Falk-Brynhildsen K, Soderquist B, Friberg O, Nilsson UG. Response to M.H. Stevens and N.M. Klinger, re: Bacterial recolonization of the skin and wound contamination during cardiac surgery. J Hosp Infect. 2013 Dec;85(4):325. doi: 10.1016/j.jhin.2013.09.001. Epub 2013 Sep 17. No abstract available.
- Results publication: PubMed 23623487Falk-Brynhildsen K, Soderquist B, Friberg O, Nilsson UG. Bacterial recolonization of the skin and wound contamination during cardiac surgery: a randomized controlled trial of the use of plastic adhesive drape compared with bare skin. J Hosp Infect. 2013 Jun;84(2):151-8. doi: 10.1016/j.jhin.2013.02.011. Epub 2013 Apr 25.
- Individual participant dataSharing planned: No
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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.
Ulrica Nilsson, PhD, Professor principal investigator
Örebro University, faculty of Medicine and Health , Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Plastic adesive drape and Microbial Sealant in people with Surgical Wound Infection, run by Örebro University, Sweden at 1 site in Sweden.
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 1 inclusion and 1 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 19 Apr 2016. 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 Sweden. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bacterial samples (time frame: Bacterial samples are taken on eight occasionson the chest and at five occations). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01316588, which also lists 3 linked publications.
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 19 Apr 2016.