Post-operative ComplicationsNCT01450631
The Use of the Prevena™ Incision Management System on Post-Surgical Cesarean Section Incisions
A study testing Prevena™ Incision Management System (PIMS) and Standard-of-care Dressing in people with Post-operative Complications and Surgical Site Infection, run by KCI USA, Inc at 1 site in United States.
Trial summary
The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-operative Complications, Surgical Site Infection, Surgical Wound Infection
- What is being tested?
- Prevena™ Incision Management System (PIMS) and Standard-of-care Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The Subject:
- is a female aged ≥ 18 years
- is able to provide her own informed consent
- will undergo a Cesarean section procedure using a subcuticular skin closure technique within the next 42 days
- will require a surgical incision able to be covered completely by the PIMS skin interface
- has a BMI ≥ 35 kg/m2 as determined during the Screening Period up to 42 days pre-surgery
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- is preoperatively assessed to undergo a procedure with a CDC Wound Classification of:
- Class I (Clean): An uninfected operative wound in which no inflammation is encountered and the respiratory, alimentary, genital, or uninfected urinary tract is not entered
- OR -
- Class II (Clean Contaminated): An operative wound in which the respiratory, alimentary, genital, or uninfected urinary tract are entered under controlled conditions and without unusual contamination
- is willing and able to return for all scheduled and required study visits
- is not concurrently enrolled in another clinical intervention trial which may impact maternal health or the surgical site
Who cannot join
- The Subject:
- is ASA Class P4, P5, or P6 (Appendix F - American Society of Anesthesiologists (ASA) Physical Status Classification System)
- has a systemic bacterial or fungal infection at the time of surgery
- has a remote-site skin infection at the time of surgery
- has a life expectancy of < 12 months
- is preoperatively assessed to undergo a procedure with a CDC Wound Classification of:
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- Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract
- OR -
- Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera
- experiences intraoperative hemorrhage requiring transfusion, disseminated-intravascular coagulopathy (DIC) or other medical or surgical condition during the Cesarean section deemed by the investigator to pose a prohibitively high risk for surgical re-exploration
- who, in the investigator's opinion, would have any clinically significant condition that would impair the participant's ability to comply with the study procedures
- has a known allergy or hypersensitivity to silver, or drape materials that contain acrylic adhesives
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: A Prospective, Randomized, Evaluation of the Prevena™ Incision Management System on Closed Incisions in Obese Subjects Undergoing Cesarean Section Surgery
The purpose of this study is to compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.
Read the detailed description
This is a randomized, open-label, single-center, Phase IV, comparative interventional study looking at the effect of the Prevena™ Incision Management System (PIMS) on Cesarean section Subjects compared to a control arm treated with a standard-of-care surgical incision dressing. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of PIMS on closed incisions. Clinical outcomes of interest for this study are defined as Surgical Site Occurrences (SSOs) that include unanticipated local inflammatory response, prolonged drainage, fluid collection, dehiscence, and surgical site infection (SSI). This investigation will compare these outcomes to a control group consisting of Subjects screened for the same inclusion and exclusion criteria but treated with a standard-of-care surgical incision dressing.
- Being tested
- Prevena™ Incision Management System (PIMS), Standard-of-care Dressing
- Keywords
- surgical site infection, nosocomial infection, post-operative complication, surgical incision risk, surgical incision infection, negative pressure wound therapy, wound management, cesarean section surgery, wound dehiscence, wound infection, surgical closure, wound disruption, subcutaneous approximation, wound separation, seroma, hematoma, subcutaneous closure, obesity, cesarean, incision
- Medical subject headings
- Surgical Wound Infection, Cross Infection, Wound Infection, Seroma, Hematoma, Obesity, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevena™ Incision Management System (PIMS)Device
Also called PIMS, NPWT, Negative Pressure Wound Therapy
PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister.
Standard-of-care DressingDevice
Also called Standard Dressing
The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy.
| Study group | Role | What they receive |
|---|---|---|
| Standard Dressing | Active comparator | Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions. Receives: Device: Standard-of-care Dressing |
| Prevena™ (PIMS) | Experimental | PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. Receives: Device: Prevena™ Incision Management System (PIMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.
Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include:
- Unanticipated local inflammatory response
- Prolonged drainage
- Fluid collection
- Dehiscence
- Surgical site infection (SSI)
Measured: Post-op Day 42 (+/- 10 days) after Cesarean section surgery
Secondary outcomes (1)
Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.
Incidence rate of surgical incision intervention (SII) post Cesarean section surgery. Interventions include:
- Antimicrobials for surgical site infection
- Surgical drainage of the incision
- Surgical incision packing
- Adjunctive negative pressure therapy
- Debridement
- Re-operation
Measured: Post-op Day: 42 (+/- 10 days) after Cesarean section surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startFeb 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-operative ComplicationsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- KCI USA, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Heine, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450631
- Sponsor's protocol ID
- AHS.2011.Prevena.Heine.03
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2011
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Evaluation of the Prevena™ Incision Management System on Closed Incisions in Obese Subjects Undergoing Cesarean Section Surgery
- ClinicalTrials.gov ID
- NCT01450631
- Acronym / sponsor ID
- AHS.2011.Prevena.Heine.03
- Keywords
- surgical site infection, nosocomial infection, post-operative complication, surgical incision risk, surgical incision infection, negative pressure wound therapy, wound management, cesarean section surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- KCI USA, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Oct 2011 (estimated)
- Results
- Posted 1 Aug 2014
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 compare the post-surgical standard-of-care dressing to the Prevena™ Incision Management System in women undergoing Cesarean section surgery.
Detailed description
This is a randomized, open-label, single-center, Phase IV, comparative interventional study looking at the effect of the Prevena™ Incision Management System (PIMS) on Cesarean section Subjects compared to a control arm treated with a standard-of-care surgical incision dressing. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of PIMS on closed incisions. Clinical outcomes of interest for this study are defined as Surgical Site Occurrences (SSOs) that include unanticipated local inflammatory response, prolonged drainage, fluid collection, dehiscence, and surgical site infection (SSI). This investigation will compare these outcomes to a control group consisting of Subjects screened for the same inclusion and exclusion criteria but treated with a standard-of-care surgical incision dressing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dressing | Active comparator | Device: Standard-of-care DressingStandard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions. |
| Prevena™ (PIMS) | Experimental | Device: Prevena™ Incision Management System (PIMS)PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- is a female aged ≥ 18 years
- is able to provide her own informed consent
- will undergo a Cesarean section procedure using a subcuticular skin closure technique within the next 42 days
- will require a surgical incision able to be covered completely by the PIMS skin interface
- has a BMI ≥ 35 kg/m2 as determined during the Screening Period up to 42 days pre-surgery
Key exclusion criteria (12 listed)
- is ASA Class P4, P5, or P6 (Appendix F - American Society of Anesthesiologists (ASA) Physical Status Classification System)
- has a systemic bacterial or fungal infection at the time of surgery
- has a remote-site skin infection at the time of surgery
- has a life expectancy of < 12 months
- is preoperatively assessed to undergo a procedure with a CDC Wound Classification of:
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 |
|---|---|---|
| Prevena™ Incision Management System (PIMS)Also: PIMS, NPWT, Negative Pressure Wound TherapyPIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. | Device | Prevena™ (PIMS) |
| Standard-of-care DressingAlso: Standard DressingThe standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy. | Device | Standard Dressing |
Primary outcome
Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.
Time frame: Post-op Day 42 (+/- 10 days) after Cesarean section surgery
Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include: * Unanticipated local inflammatory response * Prolonged drainage * Fluid collection * Dehiscence * Surgical site infection (SSI)
1 secondary outcome
Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.
Time frame: Post-op Day: 42 (+/- 10 days) after Cesarean section surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert Heine, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevena™ Incision Management System (PIMS) and Standard-of-care Dressing in people with Post-operative Complications and Surgical Site Infection, run by KCI USA, Inc 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 12 inclusion and 12 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 16 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 1 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery. (time frame: Post-op Day 42 (+/- 10 days) after Cesarean section 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 16 Oct 2024.