Surgical Site InfectionNCT02685696
Surgical Site Infection in Caesarean Section Using Alexis O Compared to Metal Retractors
A study testing Alexis O Retractor and Metal Retractor in people with Surgical Site Infection, run by Charite University, Berlin, Germany.
Trial summary
Objective: To investigate if the use of the newly designed Alexis O Retractor leads to improved intra-operative and post-operative surgical outcomes in the setting of planned elective Caesarean Sections. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Alexis O Retractor and Metal Retractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Feb 2016
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women
- Elective Caesarean Section
- First Caesarean Section
Who cannot join
- Diabetes
- Chronic auto immune diseases
- Lupus
- Immune deficiency diseases
- HIV
- known bleeding disorders
Show all 14Show fewer
- full anti-coagulation therapy
- wound healing problems
- previous Caesarean Section
- major abdominal surgery
- laparotomy
- active phase of labor
- suspected chorioamnionitis
- confirmed chorioamnionitis
About this study
Official title: To Investigate the Incidence of Surgical Site Infection in Low Risk Women Having a First Time Planned Caesarean Section Using the Alexis O Retractor and the Traditional Metal Retractor
Objective:
To investigate if the use of the newly designed Alexis O Retractor leads to improved intra-operative and post-operative surgical outcomes in the setting of planned elective Caesarean Sections.
Read more
Study Design:
This ethically approved study is designed as a prospective, randomized controlled trial in planned, first time Caesarean Sections with 200 patients randomized to either the Alexis-O Retractor group or the conventional group. Patients with wound healing problems, connective tissue disorders, insulin dependent diabetes, bleeding disorders, previous major abdominal surgery and chorioamnionitis are excluded. Outcomes include surgical site infection, intraoperative parameters such as tissue damage, postoperative analgesia requirements and patient satisfaction scores.
Read the detailed description
Main Hypothesis:
Does the use of the newly designed Alexis O Retractor lead to improved Surgical Site Infection rates intra-operative and post-operative surgical outcomes in the setting of planned elective first time Caesarean Sections in patients compared to the traditional self-retaining metal retractor?
Secondary Hypotheses:
Does the Alexis O Retractor lead to improved intra-operative and post-operative surgical outcomes in the setting of planned elective Caesarean Sections?
Study Design:
The Study is designed as a prospective, randomized controlled trial with 100 patients randomized to the Alexis O Retractor group and 100 patients to the conventional group.
All patients will be recruited following a thorough discussion about the purpose and methodology of the study and full documented consent will be obtained prior to randomization.
Patients with wound healing problems, connective tissue disorders, diabetes, bleeding disorders, previous abdominal surgery apart from laparoscopy and chorioamnionitis will be excluded.
All surgical operators are thoroughly trained in the use and application of the Alexis O Retractor prior to the start of the study and supported by regular teaching demonstrations. The Obstetric Theatre Team is informed and trained in use and application of the Alexis O Retractor within the Study Design.
Ethical Approval:
Ethical Approval has already been obtained from the Ethics committee at the Charité University Hospital Committee and in keeping with ethical standards.
Statistics:
- Data analysis and statistical comparisons will be performed by the appropriate robust statistical methodology.
- Comparisons to be investigated
- Subjective Assessment of the Ease of Application of Retractor Instrument
- Incision to Delivery Time
- Incision to Skin Suture Time
- Subjective Assessment of Visualized Operative Field
- Subjective Assessment of Freedom of Surgical Movement
- Interference from Descending Bowel or Adnexal Tissue
- Bowel and Bladder Trauma
- Need for Bowel Packing
- Need for Paracolic Cleaning of Blood and Amniotic Fluid
- Need for Uterus Exteriorization Intraoperatively
- Fascial Trauma
- Muscle Trauma
- Muscle Suturing
- Coagulation of the Subcutaneous Tissue
- Subcutaneous Tissue Thickness
- Skin Lacerations
- Trauma to the Baby
- Estimated Blood Loss
- Ease of Retractor Removal
- Analgesia Requirements Post Operative
- Wound Healing Problems on Discharge and at 6 Weeks (Telephone Interview)
- Wound Infections (As defined by Centers for Disease Control)
- Time to Hospital Discharge
- 6-Week Scar Pain Scores (Telephone Interview)
- Patient Satisfaction with Wound Healing (Telephone Interview)
- Conditions
- Surgical Site Infection
- Being tested
- Alexis O Retractor, Metal Retractor
- 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.
Alexis O RetractorDevice
A newly developed abdominal wall retractor for Caesarean Section is the Alexis O Ring which is formed of 2 rings and a interconnecting plastic polyurethane sheath where the flexible inner ring is placed into the abdomen and where the rigid outer ring is rolled to create tension on the plastic sheath providing 360° abdominal wound retraction with simultaneously a tamponade effect whilst covering the abdominal wound during the Caesarean Section and delivery of the baby.
Metal RetractorDevice
Also called Collins
The traditional self-retaining metal Collins Caesarean Wound Retractor.
| Study group | Role | What they receive |
|---|---|---|
| Alexis O Retractor | Experimental | Group 1 received the Alexis-O-Retractor at thet time of first Caesarean Section Receives: Device: Alexis O Retractor |
| Metal Retractor | Active comparator | Group 2 received the traditional self retaining metal Retractor at thet time of first Caesarean Section Receives: Device: Metal Retractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical site infection in low risk women having a first time planned Caesarean Section using the Alexis O Retractor compared to the traditional Metal Retractor.
Measured: 6-8 Weeks after Surgery
Secondary outcomes (24)
Application Satisfaction Scale Scores
Measured: Immediate Postoperative
Removal Satisfaction Scale Scores
Measured: On the day of Surgery (Day 0)
Post Operative Pain Scale Scores at Discharge
Measured: On the day of discharge (3-5 days)
Post Operative Pain at 6 Weeks
Measured: 6 weeks post operative
Patients with Wound Dehisence at Discharge
Measured: On the day of discharge (3-5 days)
Patients with either open wounds, infected wounds, bleeding wounds or painful wound at 6 Weeks
Measured: 6 weeks post operative
Blood Loss Volume
Measured: On the day of Surgery (Day 0)
Visual Field Satisfaction Scores
Measured: On the day of Surgery (Day 0)
Freedom of Movement Satisfaction Scores
Measured: On the day of Surgery (Day 0)
No. Patients with Prolapsing Bowel in the operative field at the time of Caesarean Section
Measured: On the day of Surgery (Day 0)
No. of Patients needing repositioning of prolapsing bowel at the time of Caesarean
Measured: On the day of Surgery (Day 0)
No. of Patients with bowel injury sustained at the time of Caesarean Section
Measured: On the day of Surgery (Day 0)
No. of Patients sustaining bladder injury at the time of Caesarean Section
Measured: On the day of Surgery (Day 0)
No. of Patients where bowel packing with abdominal swabs was performed at the time of Caesarean Section
Measured: On the day of Surgery (Day 0)
No. of Patients where suction of Blood and Liquor from the parabolic gutters was necessary at the time of Caesarean Section
Measured: On the day of Surgery (Day 0)
No. of Patients where the Uterus was exteriorized at the time of Caesarean Section
Measured: On the day of Surgery (Day 0)
No. of Patients with Rectus Sheath Fascial Tears at the time of Caesarean Section
Measured: On the day of Surgery (Day 0)
No. of Patients with Rectus Muscle Tearing at the time of Caesarean Section
Measured: On the day of Surgery (Day 0)
No. of Patients where Rectus Muscle Suturing was performed at the time of Caesarean
Measured: On the day of Surgery (Day 0)
No. of Patients where Subcutaneous Electro-Coagulation was performed at the time of Caesarean Section
Measured: On the day of Surgery (Day 0)
No. of Patients with lacerations to the skin wound edges at the time of Caesarean Section
Measured: On the day of Surgery (Day 0)
No. of Patients where the Baby was cut at the time of Caesarean Section
Measured: On the day of Surgery (Day 0)
Wound Healing Satisfaction at 6 Weeks
Measured: 6 weeks post operative.
Time to Discharge
Measured: 3-5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startOct 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry Hinkson, Charite University, Berlin, Germany
- Investigators
- Larry Hinkson, MBBS,MRCOG, Principal investigator, Charité University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685696
- Sponsor's protocol ID
- AlexisO1
- Status last verified
- Feb 2016
- First submitted
- 8 Feb 2016
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Klingel ML, Patel SV. A meta-analysis of the effect of inspired oxygen concentration on the incidence of surgical site infection following cesarean section. Int J Obstet Anesth. 2013 Apr;22(2):104-12. doi: 10.1016/j.ijoa.2013.01.001. Epub 2013 Mar 13.
PubMed 23490472Horiuchi T, Tanishima H, Tamagawa K, Sakaguchi S, Shono Y, Tsubakihara H, Tabuse K, Kinoshita Y. A wound protector shields incision sites from bacterial invasion. Surg Infect (Larchmt). 2010 Dec;11(6):501-3. doi: 10.1089/sur.2009.072. Epub 2010 Sep 17.
PubMed 20849290
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Incidence of Surgical Site Infection in Low Risk Women Having a First Time Planned Caesarean Section Using the Alexis O Retractor and the Traditional Metal Retractor
- ClinicalTrials.gov ID
- NCT02685696
- Acronym / sponsor ID
- AlexisO1
- Conditions
- Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 19 Feb 2016 (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.
Objective:
To investigate if the use of the newly designed Alexis O Retractor leads to improved intra-operative and post-operative surgical outcomes in the setting of planned elective Caesarean Sections.
Study Design:
This ethically approved study is designed as a prospective, randomized controlled trial in planned, first time Caesarean Sections with 200 patients randomized to either the Alexis-O Retractor group or the conventional group. Patients with wound healing problems, connective tissue disorders, insulin dependent diabetes, bleeding disorders, previous major abdominal surgery and chorioamnionitis are excluded. Outcomes include surgical site infection, intraoperative parameters such as tissue damage, postoperative analgesia requirements and patient satisfaction scores.
Detailed description
Main Hypothesis:
Does the use of the newly designed Alexis O Retractor lead to improved Surgical Site Infection rates intra-operative and post-operative surgical outcomes in the setting of planned elective first time Caesarean Sections in patients compared to the traditional self-retaining metal retractor?
Secondary Hypotheses:
Does the Alexis O Retractor lead to improved intra-operative and post-operative surgical outcomes in the setting of planned elective Caesarean Sections?
Study Design:
The Study is designed as a prospective, randomized controlled trial with 100 patients randomized to the Alexis O Retractor group and 100 patients to the conventional group.
All patients will be recruited following a thorough discussion about the purpose and methodology of the study and full documented consent will be obtained prior to randomization.
Patients with wound healing problems, connective tissue disorders, diabetes, bleeding disorders, previous abdominal surgery apart from laparoscopy and chorioamnionitis will be excluded.
All surgical operators are thoroughly trained in the use and application of the Alexis O Retractor prior to the start of the study and supported by regular teaching demonstrations. The Obstetric Theatre Team is informed and trained in use and application of the Alexis O Retractor within the Study Design.
Ethical Approval:
Ethical Approval has already been obtained from the Ethics committee at the Charité University Hospital Committee and in keeping with ethical standards.
Statistics:
- Data analysis and statistical comparisons will be performed by the appropriate robust statistical methodology.
- Comparisons to be investigated
- Subjective Assessment of the Ease of Application of Retractor Instrument
- Incision to Delivery Time
- Incision to Skin Suture Time
- Subjective Assessment of Visualized Operative Field
- Subjective Assessment of Freedom of Surgical Movement
- Interference from Descending Bowel or Adnexal Tissue
- Bowel and Bladder Trauma
- Need for Bowel Packing
- Need for Paracolic Cleaning of Blood and Amniotic Fluid
- Need for Uterus Exteriorization Intraoperatively
- Fascial Trauma
- Muscle Trauma
- Muscle Suturing
- Coagulation of the Subcutaneous Tissue
- Subcutaneous Tissue Thickness
- Skin Lacerations
- Trauma to the Baby
- Estimated Blood Loss
- Ease of Retractor Removal
- Analgesia Requirements Post Operative
- Wound Healing Problems on Discharge and at 6 Weeks (Telephone Interview)
- Wound Infections (As defined by Centers for Disease Control)
- Time to Hospital Discharge
- 6-Week Scar Pain Scores (Telephone Interview)
- Patient Satisfaction with Wound Healing (Telephone Interview)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alexis O Retractor | Experimental | Device: Alexis O RetractorGroup 1 received the Alexis-O-Retractor at thet time of first Caesarean Section |
| Metal Retractor | Active comparator | Device: Metal RetractorGroup 2 received the traditional self retaining metal Retractor at thet time of first Caesarean Section |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women
- Elective Caesarean Section
- First Caesarean Section
Key exclusion criteria (14 listed)
- Diabetes
- Chronic auto immune diseases
- Lupus
- Immune deficiency diseases
- HIV
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 |
|---|---|---|
| Alexis O RetractorA newly developed abdominal wall retractor for Caesarean Section is the Alexis O Ring which is formed of 2 rings and a interconnecting plastic polyurethane sheath where the flexible inner ring is placed into the abdomen and where the rigid outer ring is rolled to create tension on the plastic sheath providing 360° abdominal wound retraction with simultaneously a tamponade effect whilst covering the abdominal wound during the Caesarean Section and delivery of the baby. | Device | Alexis O Retractor |
| Metal RetractorAlso: CollinsThe traditional self-retaining metal Collins Caesarean Wound Retractor. | Device | Metal Retractor |
Primary outcome
Incidence of surgical site infection in low risk women having a first time planned Caesarean Section using the Alexis O Retractor compared to the traditional Metal Retractor.
Time frame: 6-8 Weeks after Surgery
24 secondary outcomes
Application Satisfaction Scale Scores
Time frame: Immediate Postoperative
Removal Satisfaction Scale Scores
Time frame: On the day of Surgery (Day 0)
Post Operative Pain Scale Scores at Discharge
Time frame: On the day of discharge (3-5 days)
Post Operative Pain at 6 Weeks
Time frame: 6 weeks post operative
Patients with Wound Dehisence at Discharge
Time frame: On the day of discharge (3-5 days)
Patients with either open wounds, infected wounds, bleeding wounds or painful wound at 6 Weeks
Time frame: 6 weeks post operative
Blood Loss Volume
Time frame: On the day of Surgery (Day 0)
Visual Field Satisfaction Scores
Time frame: On the day of Surgery (Day 0)
Freedom of Movement Satisfaction Scores
Time frame: On the day of Surgery (Day 0)
No. Patients with Prolapsing Bowel in the operative field at the time of Caesarean Section
Time frame: On the day of Surgery (Day 0)
No. of Patients needing repositioning of prolapsing bowel at the time of Caesarean
Time frame: On the day of Surgery (Day 0)
No. of Patients with bowel injury sustained at the time of Caesarean Section
Time frame: On the day of Surgery (Day 0)
No. of Patients sustaining bladder injury at the time of Caesarean Section
Time frame: On the day of Surgery (Day 0)
No. of Patients where bowel packing with abdominal swabs was performed at the time of Caesarean Section
Time frame: On the day of Surgery (Day 0)
No. of Patients where suction of Blood and Liquor from the parabolic gutters was necessary at the time of Caesarean Section
Time frame: On the day of Surgery (Day 0)
No. of Patients where the Uterus was exteriorized at the time of Caesarean Section
Time frame: On the day of Surgery (Day 0)
No. of Patients with Rectus Sheath Fascial Tears at the time of Caesarean Section
Time frame: On the day of Surgery (Day 0)
No. of Patients with Rectus Muscle Tearing at the time of Caesarean Section
Time frame: On the day of Surgery (Day 0)
No. of Patients where Rectus Muscle Suturing was performed at the time of Caesarean
Time frame: On the day of Surgery (Day 0)
No. of Patients where Subcutaneous Electro-Coagulation was performed at the time of Caesarean Section
Time frame: On the day of Surgery (Day 0)
No. of Patients with lacerations to the skin wound edges at the time of Caesarean Section
Time frame: On the day of Surgery (Day 0)
No. of Patients where the Baby was cut at the time of Caesarean Section
Time frame: On the day of Surgery (Day 0)
Wound Healing Satisfaction at 6 Weeks
Time frame: 6 weeks post operative.
Time to Discharge
Time frame: 3-5 Days
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 Feb 2016.
- Background: PubMed 23490472Klingel ML, Patel SV. A meta-analysis of the effect of inspired oxygen concentration on the incidence of surgical site infection following cesarean section. Int J Obstet Anesth. 2013 Apr;22(2):104-12. doi: 10.1016/j.ijoa.2013.01.001. Epub 2013 Mar 13.
- Background: PubMed 20849290Horiuchi T, Tanishima H, Tamagawa K, Sakaguchi S, Shono Y, Tsubakihara H, Tabuse K, Kinoshita Y. A wound protector shields incision sites from bacterial invasion. Surg Infect (Larchmt). 2010 Dec;11(6):501-3. doi: 10.1089/sur.2009.072. Epub 2010 Sep 17.
- 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.
Larry Hinkson, MBBS,MRCOG principal investigator
Charité University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Alexis O Retractor and Metal Retractor in people with Surgical Site Infection, run by Charite University, Berlin, Germany.
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 3 inclusion and 14 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of surgical site infection in low risk women having a first time planned Caesarean Section using the Alexis O Retractor compared to the traditional Metal Retractor. (time frame: 6-8 Weeks after Surgery). 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 NCT02685696, which also lists 2 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 Feb 2016.