Surgical Wound InfectionAPIPICSNCT01891006
Intervention for Postpartum Infections Following Caesarean Section
A study testing Negative Pressure Wound Therapy and Standard wound dressing in people with Surgical Wound Infection and Infection; Cesarean Section, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to examine whether Negative Pressure Wound Therapy is an effective wound treatment compared to conventional wound treatment in the period of time from reoperation to re-suturing in women having surgical wound rupture after 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?
- Negative Pressure Wound Therapy and Standard wound dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- May 2011to Jul 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 year
- Women, who can read and understand Danish
Who cannot join
- Serious illness requiring medical treatment, such as cancer
- Stillborn child
- If the fascia is ruptured
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervention for Postpartum Infections Following Caesarean Section - a Randomized Controlled Trial
The purpose of this study is to examine whether Negative Pressure Wound Therapy is an effective wound treatment compared to conventional wound treatment in the period of time from reoperation to re-suturing in women having surgical wound rupture after Caesarean Section.
Read the detailed description
This study is a non-blinded randomized controlled trial and a concurrent Health Economic. The study examines the effect on wound healing using NPWT compared with conventional wound treatment in women, who experience spontaneous dehiscence or where a surgeon deliberately opens the wound after Caesarean Section (CS).
Women, who have given informed consent, will be randomized to either intervention or control group via a computer-generated randomization program. It is not possible to blind either participants or therapists. The analysis will be carried out on an intention to treat basis.
Women with post-CS wound infection will be hospitalized and the wound will be reopened and cleaned under general anaesthesia. In the intervention group women will be treated with NPWT. The change of wound dressing on the second day takes place in the obstetrical or plastic surgery ward. On the fourth day, the NPWT material will be removed and the wound evaluated before re-suturing. In the control group the wound will be treated with a hydrofiber or alginate dressing. Changes of wound dressing will take place on the second and fourth days as in the intervention group. In both groups, when the wound is evaluated on the second and fourth day, it will be described and measured (depth, width, length). After four days of treatment, the wound will be re-sutured in both groups. It is expected that some wounds are not suitable for re-suturing on the fourth day. If a woman does not want to participate, she will receive the conventional treatment, which corresponds to the treatment in the control group. 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
- Negative Pressure Wound Therapy, Standard wound dressing
- Keywords
- Randomized Controlled Trial, Economical Evaluation, Caesarean Section, Cesarean Section, Postoperative Wound Treatment, Surgical Site Infections, Wound Infections, Infectious Morbidity, Negative Pressure Wound Therapy
- Medical subject headings
- Surgical Wound Infection, Infections, Wounds and Injuries, Rupture, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyDevice
Also called RENASYS-G from Smith&Nephew
The Negative Pressure Wound Therapy are changed on the 2. day and removed on the 4. day after the re-operation.
Standard wound dressingOther
The standard wound dressing is a a hydrofiber or alginate dressing used for open wounds
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Negative Pressure Wound Therapy (NPWT) is an alternative method of conservative wound management, which uses negative pressure to promote wound healing in both chronic and acute wounds. The rationale for using NPWT is that it mechanically stimulates the formation of new tissue and removes wound fluid and infectious material Receives: Device: Negative Pressure Wound Therapy |
| A standard wound dressing | Other | The standard wound dressing is a hydrofiber or alginate dressing, used for open wound Receives: Other: Standard wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of re-rupture in each study group
Measured: Within the first 30 days after surgery
Secondary outcomes (4)
Length of hospitalization
Measured: Within the first 30 days after Caesarean Section
Readmission to hospital due to wound complications after the re-operation
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 on the 4 day after the re-operation and at the 6 and 12 months follow-up.
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 after the re-operation. After study completion pictures of the scars will be evaluated by two blinded plastic surgeons, using two predefined scar scales.
Measured: A 6 and 12 months follow-up
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 startMay 2011
- Primary completionNov 2014
- Study completionJul 2015
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT01891006
- Sponsor's protocol ID
- S-20120163
- Acronym
- APIPICS
- Status last verified
- Oct 2016
- First submitted
- 27 Jun 2013
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Postpartum Infections Following Caesarean Section - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01891006
- Acronym / sponsor ID
- APIPICS / S-20120163
- 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, Cesarean Section, Postoperative Wound Treatment, Surgical Site Infections, Wound Infections, Infectious Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 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
- May 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jul 2015 (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 Negative Pressure Wound Therapy is an effective wound treatment compared to conventional wound treatment in the period of time from reoperation to re-suturing in women having surgical wound rupture after Caesarean Section.
Detailed description
This study is a non-blinded randomized controlled trial and a concurrent Health Economic. The study examines the effect on wound healing using NPWT compared with conventional wound treatment in women, who experience spontaneous dehiscence or where a surgeon deliberately opens the wound after Caesarean Section (CS).
Women, who have given informed consent, will be randomized to either intervention or control group via a computer-generated randomization program. It is not possible to blind either participants or therapists. The analysis will be carried out on an intention to treat basis.
Women with post-CS wound infection will be hospitalized and the wound will be reopened and cleaned under general anaesthesia. In the intervention group women will be treated with NPWT. The change of wound dressing on the second day takes place in the obstetrical or plastic surgery ward. On the fourth day, the NPWT material will be removed and the wound evaluated before re-suturing. In the control group the wound will be treated with a hydrofiber or alginate dressing. Changes of wound dressing will take place on the second and fourth days as in the intervention group. In both groups, when the wound is evaluated on the second and fourth day, it will be described and measured (depth, width, length). After four days of treatment, the wound will be re-sutured in both groups. It is expected that some wounds are not suitable for re-suturing on the fourth day. If a woman does not want to participate, she will receive the conventional treatment, which corresponds to the treatment in the control group. Women, who do not wish to participate, will be asked for permission to use their data in the analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Device: Negative Pressure Wound TherapyNegative Pressure Wound Therapy (NPWT) is an alternative method of conservative wound management, which uses negative pressure to promote wound healing in both chronic and acute wounds. The rationale for using NPWT is that it mechanically stimulates the formation of new tissue and removes wound fluid and infectious material |
| A standard wound dressing | Other | Other: Standard wound dressingThe standard wound dressing is a hydrofiber or alginate dressing, used for open wound |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 year
- Women, who can read and understand Danish
Key exclusion criteria (3 listed)
- Serious illness requiring medical treatment, such as cancer
- Stillborn child
- If the fascia is ruptured
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 |
|---|---|---|
| Negative Pressure Wound TherapyAlso: RENASYS-G from Smith&NephewThe Negative Pressure Wound Therapy are changed on the 2. day and removed on the 4. day after the re-operation. | Device | Negative Pressure Wound Therapy |
| Standard wound dressingThe standard wound dressing is a a hydrofiber or alginate dressing used for open wounds | Other | A standard wound dressing |
Primary outcome
The frequency of re-rupture in each study group
Time frame: Within the first 30 days after surgery
4 secondary outcomes
Length of hospitalization
Time frame: Within the first 30 days after Caesarean Section
Readmission to hospital due to wound complications after the re-operation
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
The cosmetic outcome as a measure of satisfaction
Time frame: A 6 and 12 months follow-up
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 18 Oct 2016.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy and Standard wound dressing in people with Surgical Wound Infection and Infection; Cesarean Section, run by Odense University Hospital at 1 site 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 2 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 18 Oct 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 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 frequency of re-rupture 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 18 Oct 2016.