Surgical Wound InfectionPhase 1VACCSNCT02390401
Vacuum Assisted Closure for Cesarean Section
A Phase 1 study testing Vacuum-assisted closure and Standard sterile dressing in people with Surgical Wound Infection, run by Dartmouth-Hitchcock Medical Center at 4 sites in United States.
Trial summary
To study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean section incisions in the obese compared with standard sterile dressing. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Vacuum-assisted closure and Standard sterile dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2015to Sep 2017
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients that have undergone cesarean section for delivery; have a BMI greater or equal to 35. All cases of cesarean section including primary and repeat, scheduled and urgent.
Who cannot join
- Patients who deliver vaginally; age less than 18 years old; silver allergy; non-English speaking
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Women's Care of Nashua
Nashua, New Hampshire, 03060-3922
Dartmouth-Hitchcock Nashua
Nashua, New Hampshire, 03060
Southern New Hampshire Medical Center
Nashua, New Hampshire, 03060
About this study
Official title: Incisional VAC at Cesarean Section for Prevention of Post Operative Wound Complications in the Obese
To study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean section incisions in the obese compared with standard sterile dressing.
Read the detailed description
The prevalence of obesity (defined as body mass index (BMI, kg/m2) ≥ 30) has significantly increased, affecting approximately 35% of adult females in the United States, according to CDC 2009-2010 statistics. Obesity has a significant impact on pregnancy, including increased need for cesarean section and post-operative wound complications. Infection rates have been reported to be between 10 and 30%. The advent in 1997 of negative pressure therapy (NPT), also known as vacuum assisted closure (VAC), has vastly changed wound care management. Briefly, VAC has been traditionally applied to a chronic wound to create negative or sub-atmospheric pressure, thus promoting wound healing by decreasing edema and increasing blood flow and formation of granulation tissue. Use of this therapy at the time of primary closure of a surgical incision (first trialed in 2006 and termed "Incisional VAC") has provided a promising approach to reducing post-operative wound infection. Incisional VAC has been explored primarily in the orthopedic and cardiothoracic fields, but very few studies have examined the use on abdominal incisions, and only one to date on cesarean section incisions.
- Conditions
- Surgical Wound Infection
- Being tested
- Vacuum-assisted closure, Standard sterile dressing
- 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.
Vacuum-assisted closureDevice
Also called Prevena, Incisional VAC
Prevena (VAC) device at the time of primary closure for a cesarean section, left in place for 5-7 days postoperatively.
Standard sterile dressingDevice
Standard sterile dressing at the time of primary closure for a cesarean section, left in place for 1-2 days postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Vacuum-assisted closure (VAC) | Experimental | Prevena (VAC) device Receives: Device: Vacuum-assisted closure |
| Standard sterile dressing | Active comparator | Standard sterile dressing Receives: Device: Standard sterile dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative wound infection
Determine number of post-operative wound infections
Measured: 6 weeks post-operative
Secondary outcomes (6)
Rate of seroma
Calculate incidence of seroma
Measured: 6 weeks post-operative
Rate of hematoma
Calculate incidence of hematoma
Measured: 6 weeks post-operative
Deep and superficial infection
Calculate incidence of deep and superficial infection
Measured: 6 weeks post-operative
Readmission for infection
Calculate incidence of readmission to hospital for infection due to cesarean incision
Measured: 6 weeks post-operative
Re-operation
Calculate incidence of re-operation to patients enrolled in study
Measured: 6 weeks post-operative
Antibiotic treatment
Calculate incidence of need for antibiotic treatment for enrolled patients
Measured: 6 weeks post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2017
- Study completionSep 2017
Why it stopped: Continuation was futile per calculation recommend by data \& safety monitoring committee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Southern New Hampshire Medical Center
- Responsible party
- Principal investigator, Zachary Spalding, Dartmouth-Hitchcock Medical Center
- Investigators
- Zachary Spalding, MD, Principal investigator, Dartmouth-Hitchcock Medical CenterKristina Wihbey, MD, Study chair, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390401
- Sponsor's protocol ID
- D15054
- Acronym
- VACCS
- Status last verified
- May 2018
- First submitted
- 11 Mar 2015
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Wihbey KA, Joyce EM, Spalding ZT, Jones HJ, MacKenzie TA, Evans RH, Fung JL, Goldman MB, Erekson E. Prophylactic Negative Pressure Wound Therapy and Wound Complication After Cesarean Delivery in Women With Class II or III Obesity: A Randomized Controlled Trial. Obstet Gynecol. 2018 Aug;132(2):377-384. doi: 10.1097/AOG.0000000000002744.
PubMed 29995726
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incisional VAC at Cesarean Section for Prevention of Post Operative Wound Complications in the Obese
- ClinicalTrials.gov ID
- NCT02390401
- Acronym / sponsor ID
- VACCS / D15054
- Conditions
- Surgical Wound Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Continuation was futile per calculation recommend by data \& safety monitoring committee
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Southern New Hampshire Medical Center
- Study start
- May 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 17 Mar 2015 (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.
To study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean section incisions in the obese compared with standard sterile dressing.
Detailed description
The prevalence of obesity (defined as body mass index (BMI, kg/m2) ≥ 30) has significantly increased, affecting approximately 35% of adult females in the United States, according to CDC 2009-2010 statistics. Obesity has a significant impact on pregnancy, including increased need for cesarean section and post-operative wound complications. Infection rates have been reported to be between 10 and 30%. The advent in 1997 of negative pressure therapy (NPT), also known as vacuum assisted closure (VAC), has vastly changed wound care management. Briefly, VAC has been traditionally applied to a chronic wound to create negative or sub-atmospheric pressure, thus promoting wound healing by decreasing edema and increasing blood flow and formation of granulation tissue. Use of this therapy at the time of primary closure of a surgical incision (first trialed in 2006 and termed "Incisional VAC") has provided a promising approach to reducing post-operative wound infection. Incisional VAC has been explored primarily in the orthopedic and cardiothoracic fields, but very few studies have examined the use on abdominal incisions, and only one to date on cesarean section incisions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vacuum-assisted closure (VAC) | Experimental | Device: Vacuum-assisted closurePrevena (VAC) device |
| Standard sterile dressing | Active comparator | Device: Standard sterile dressingStandard sterile dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that have undergone cesarean section for delivery; have a BMI greater or equal to 35. All cases of cesarean section including primary and repeat, scheduled and urgent.
Key exclusion criteria (1 listed)
- Patients who deliver vaginally; age less than 18 years old; silver allergy; non-English speaking
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 |
|---|---|---|
| Vacuum-assisted closureAlso: Prevena, Incisional VACPrevena (VAC) device at the time of primary closure for a cesarean section, left in place for 5-7 days postoperatively. | Device | Vacuum-assisted closure (VAC) |
| Standard sterile dressingStandard sterile dressing at the time of primary closure for a cesarean section, left in place for 1-2 days postoperatively. | Device | Standard sterile dressing |
Primary outcome
Post-operative wound infection
Time frame: 6 weeks post-operative
Determine number of post-operative wound infections
6 secondary outcomes
Rate of seroma
Time frame: 6 weeks post-operative
Rate of hematoma
Time frame: 6 weeks post-operative
Deep and superficial infection
Time frame: 6 weeks post-operative
Readmission for infection
Time frame: 6 weeks post-operative
Re-operation
Time frame: 6 weeks post-operative
Antibiotic treatment
Time frame: 6 weeks post-operative
Results and safety
The study was stopped early (reason given: Continuation was futile per calculation recommend by data \& safety monitoring committee). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Derived from this study: PubMed 29995726Wihbey KA, Joyce EM, Spalding ZT, Jones HJ, MacKenzie TA, Evans RH, Fung JL, Goldman MB, Erekson E. Prophylactic Negative Pressure Wound Therapy and Wound Complication After Cesarean Delivery in Women With Class II or III Obesity: A Randomized Controlled Trial. Obstet Gynecol. 2018 Aug;132(2):377-384. doi: 10.1097/AOG.0000000000002744.
- Individual participant dataSharing planned: Undecided
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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.
Zachary Spalding, MD principal investigator
Dartmouth-Hitchcock Medical Center
Kristina Wihbey, MD study chair
Dartmouth-Hitchcock Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vacuum-assisted closure and Standard sterile dressing in people with Surgical Wound Infection, run by Dartmouth-Hitchcock Medical Center at 4 sites 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 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: stopped early, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Continuation was futile per calculation recommend by data \& safety monitoring committee). Results are not available in the source record.
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?
Post-operative wound infection (time frame: 6 weeks post-operative). 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 NCT02390401, which also lists 1 linked publication.
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 22 May 2018.