Surgical Wound InfectionNCT01890720
Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section
A study testing iNPWT and Standard postoperative wound dressing in people with Surgical Wound Infection and Infection; Cesarean Section, run by Odense University Hospital at 5 sites in Denmark.
Trial summary
The purpose of this study is to examine whether obese women (BMI >= 30) who give birth by caesarean section have a reduced incidence of wound infection and dehiscence when incisional Negative Pressure Wound Therapy is applied prophylactically following caesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgical Wound Infection, Infection; Cesarean Section, Cesarean Section; Dehiscence
- What is being tested?
- iNPWT and Standard postoperative wound dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 876 participants
- Where
- 5 sitesDenmark
- Study dates
- 10 Sep 2013to Dec 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 year
- Women who can read and understand Danish
- pregestational BMI ≥ 30 kg/m2
Who cannot join
- -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Aarhus University Hospital
Aarhus, Jutland, 8200
Hospital South West Jutland
Esbjerg, Jutland, 6700
Hvidovre Hospital
Hvidovre, 2650
Hospital Lillebaelt, Kolding Hospital
Kolding, Jutland, 6000
Odense University Hospital
Odense, 5000
About this study
Official title: Use of Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section in Women With BMI >=30
The purpose of this study is to examine whether obese women (BMI >= 30) who give birth by caesarean section have a reduced incidence of wound infection and dehiscence when incisional Negative Pressure Wound Therapy is applied prophylactically following caesarean section.
Read the detailed description
This study is a non-blinded randomised controlled trial and a concurrent Health Economic Evaluation. The study examines the effect on wound healing using incisional Negative Pressure Wound Therapy (iNPWT) compared with standard postoperative dressings in women with a BMI >= 30, who has a Caesarean Section (CS). We expect to find a lower frequency of wound complications when using iNPWT directly on primary suturing compared to standard postoperative dressings in this high-risk subpopulation.
Women, who have given informed consent, will be randomised to either intervention or control group via a computer-generated randomisation program. Elective and emergency CS will be stratified to ensure roughly equal numbers in each category of CS in each arm of the study and permit valid separate and pooled analysis. The analysis will be carried out on an intention to treat basis.
The iNPWT or standard postoperative dressings will be applied in theatre immediately following the operation. In the intervention group the therapy will be left in situ for five days corresponding to the date of removal of stitches. In the control group the dressing will be left in situ for at least 24 hours as standard procedure. Women, who do not wish to participate, will be asked for permission to use their data in the analysis.
- Conditions
- Surgical Wound Infection, Infection; Cesarean Section, Cesarean Section; Dehiscence, Complications; Cesarean Section, Complications; Cesarean Section, Wound, Dehiscence, Wound; Rupture, Surgery, Cesarean Section
- Being tested
- iNPWT, Standard postoperative wound dressing
- Keywords
- Randomized Controlled Trial, Economical Evaluation, Caesarean Section, postoperative wound treatment, surgical site infections, wound infections, infectious morbidity, Negative Pressure Wound Therapy, Incisional Negative Pressure Wound Therapy, Obesity
- Medical subject headings
- Surgical Wound Infection, Infections, Wounds and Injuries, Rupture, Wound Infection, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iNPWTDevice
Also called incisional Negative Pressure Wound Therapy
The Incisional Negative Pressure Wound Therapy (iNPWT) will be applied over the clean closed incision immediately following the operation (caesarean section). In the intervention group the therapy will be left in situ for five days.
Standard postoperative wound dressingOther
A standard wound dressing will be applied over the clean closed incision immediately following the operation (caesarean section). In the control group the dressing will be left in situ for at least 24 hours as standard procedure.
| Study group | Role | What they receive |
|---|---|---|
| iNPWT | Experimental | Negative Pressure Wound Therapy (NPWT) is a mechanical wound care treatment using controlled sub-atmospheric pressure to assist and accelerate wound healing. Incisional Negative Pressure Wound Therapy (iNPWT) is a new NPWT devices, which can be used over clean closed surgical incisions. The device behaves in a similar fashion to existing conventional NPWT devices, i.e. transmission of negative pressure levels at the wound bed, tissue contraction and establishing a characteristic pattern of peri-wound blood flow and that it reduces and normalises tissue stresses at the incision Receives: Device: iNPWT |
| Standard wound dressing | Active comparator | The standard postoperative wound dressing is a normal wound dressing, used over clean closed incisions. Receives: Other: Standard postoperative wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of post-CS wound infection in each study group
Wound infection requiring antibiotic treatment
To be able to collect information about symptoms of infection after discharge a self-administered questionnaire will be sent to all participants within 30 days post-CS. Furthermore data on postoperative infections, recorded by diagnoses codes or surgical procedures, will be obtained from the Danish National Patient Registry
Measured: Within the first 30 days after surgery
Secondary outcomes (6)
Length of the primary and any secondary hospitalization
Primary for the health economic evaluation
Measured: Within the first 30 days after Caesarean Section
Readmissions to hospital/contact to the general practitioner on suspicion of infection following caesarean section
Primary for the health economic evaluation
Measured: Within the first 30 days after Caesarean Section
Number of Participants with a decreased health-related quality of life score as a measure of satisfaction and tolerability
A health-related quality of life measure, recorded in Quality Adjusted Life Years at the two interventions. The health-related quality of life score is measured 5 and 30 days post-CS. Primary for the health economic evaluation
Measured: Within the first 30 days after Caesarean Section
Antibiotic treatment on suspicion of infection after Caesarean Section
Primary for the health economic evaluation
Measured: Within the first 30 days after Caesarean Section
The cosmetic outcome as a measure of satisfaction
The scar will be evaluated by a plastic surgeon at a clinical examination 6 and 12 months post-CS. After study completion pictures of the scars will be evaluated by two unbiased plastic surgeons, using two predefined scar scales.
Measured: A 6 and 12 months follow-up
Other wound complications after caesarean section
wound separation, wound exudate
Measured: Within the first 30 days after Caesarean Section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study start10 Sep 2013
- Primary completion13 Oct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 876 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, University of Southern Denmark, Hvidovre University Hospital, Smith & Nephew, Inc.
- Responsible party
- Principal investigator, Nana Hyldig, Odense University Hospital
- Investigators
- Nana Hyldig, PhD Student, Study chair, Odense University Hospital, department of Plastic Surgery, University of Southern Denmark, Faculty of Health Sciences, institute of Clinical Research, research unit, department of Gynaecology and Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890720
- Sponsor's protocol ID
- S-20130010
- Status last verified
- Jan 2017
- First submitted
- 27 Jun 2013
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section in Women With BMI >=30
- ClinicalTrials.gov ID
- NCT01890720
- Acronym / sponsor ID
- S-20130010
- Conditions
- Surgical Wound Infection, Infection; Cesarean Section, Cesarean Section; Dehiscence, Complications; Cesarean Section, Complications; Cesarean Section, Wound, Dehiscence, Wound; Rupture, Surgery, Cesarean Section
- Keywords
- Randomized Controlled Trial, Economical Evaluation, Caesarean Section, postoperative wound treatment, surgical site infections, wound infections, infectious morbidity, Negative Pressure Wound Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 876 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, University of Southern Denmark, Hvidovre University Hospital, Smith & Nephew, Inc.
- Study start
- 10 Sep 2013
- Primary completion
- 13 Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Jul 2013 (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 examine whether obese women (BMI >= 30) who give birth by caesarean section have a reduced incidence of wound infection and dehiscence when incisional Negative Pressure Wound Therapy is applied prophylactically following caesarean section.
Detailed description
This study is a non-blinded randomised controlled trial and a concurrent Health Economic Evaluation. The study examines the effect on wound healing using incisional Negative Pressure Wound Therapy (iNPWT) compared with standard postoperative dressings in women with a BMI >= 30, who has a Caesarean Section (CS). We expect to find a lower frequency of wound complications when using iNPWT directly on primary suturing compared to standard postoperative dressings in this high-risk subpopulation.
Women, who have given informed consent, will be randomised to either intervention or control group via a computer-generated randomisation program. Elective and emergency CS will be stratified to ensure roughly equal numbers in each category of CS in each arm of the study and permit valid separate and pooled analysis. The analysis will be carried out on an intention to treat basis.
The iNPWT or standard postoperative dressings will be applied in theatre immediately following the operation. In the intervention group the therapy will be left in situ for five days corresponding to the date of removal of stitches. In the control group the dressing will be left in situ for at least 24 hours as standard procedure. Women, who do not wish to participate, will be asked for permission to use their data in the analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iNPWT | Experimental | Device: iNPWTNegative Pressure Wound Therapy (NPWT) is a mechanical wound care treatment using controlled sub-atmospheric pressure to assist and accelerate wound healing. Incisional Negative Pressure Wound Therapy (iNPWT) is a new NPWT devices, which can be used over clean closed surgical incisions. The device behaves in a similar fashion to existing conventional NPWT devices, i.e. transmission of negative pressure levels at the wound bed, tissue contraction and establishing a characteristic pattern of peri-wound blood flow and that it reduces and normalises tissue stresses at the incision |
| Standard wound dressing | Active comparator | Other: Standard postoperative wound dressingThe standard postoperative wound dressing is a normal wound dressing, used over clean closed incisions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 year
- Women who can read and understand Danish
- pregestational BMI ≥ 30 kg/m2
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| iNPWTAlso: incisional Negative Pressure Wound TherapyThe Incisional Negative Pressure Wound Therapy (iNPWT) will be applied over the clean closed incision immediately following the operation (caesarean section). In the intervention group the therapy will be left in situ for five days. | Device | iNPWT |
| Standard postoperative wound dressingA standard wound dressing will be applied over the clean closed incision immediately following the operation (caesarean section). In the control group the dressing will be left in situ for at least 24 hours as standard procedure. | Other | Standard wound dressing |
Primary outcome
The incidence of post-CS wound infection in each study group
Time frame: Within the first 30 days after surgery
Wound infection requiring antibiotic treatment To be able to collect information about symptoms of infection after discharge a self-administered questionnaire will be sent to all participants within 30 days post-CS. Furthermore data on postoperative infections, recorded by diagnoses codes or surgical procedures, will be obtained from the Danish National Patient Registry
6 secondary outcomes
Length of the primary and any secondary hospitalization
Time frame: Within the first 30 days after Caesarean Section
Readmissions to hospital/contact to the general practitioner on suspicion of infection following caesarean section
Time frame: Within the first 30 days after Caesarean Section
Number of Participants with a decreased health-related quality of life score as a measure of satisfaction and tolerability
Time frame: Within the first 30 days after Caesarean Section
Antibiotic treatment on suspicion of infection after Caesarean Section
Time frame: Within the first 30 days after Caesarean Section
The cosmetic outcome as a measure of satisfaction
Time frame: A 6 and 12 months follow-up
Other wound complications after caesarean section
Time frame: Within the first 30 days after Caesarean Section
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 31 Jan 2017.
- 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.
Nana Hyldig, PhD Student study chair
Odense University Hospital, department of Plastic Surgery, University of Southern Denmark, Faculty of Health Sciences, institute of Clinical Research, research unit, department of Gynaecology and Obstetrics
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iNPWT and Standard postoperative wound dressing in people with Surgical Wound Infection and Infection; Cesarean Section, run by Odense University Hospital at 5 sites in Denmark.
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 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 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. 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?
The incidence of post-CS wound infection in each study group (time frame: Within the first 30 days after surgery). 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 31 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.