ObesityNCT02799667
Do Single Use Negative Pressure Dressings Reduce Wound Complications in Obese Women After Cesarean Delivery
A study testing Standard Dressing and Negative Pressure Wound Therapy Dressing in people with Obesity and Surgical Site Infections, run by Tufts Medical Center at 1 site in United States.
Trial summary
The investigators aim to show that single use negative pressure dressings can decrease the rate of wound complications in obese women (BMI > 40 kg/m2) undergoing cesarean delivery at a tertiary medical center by randomizing women to receive either a single use negative pressure dressing or the standard dressing after… 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
- Obesity, Surgical Site Infections, Wound Complications
- What is being tested?
- Standard Dressing and Negative Pressure Wound Therapy Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 31 Mar 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI >40 kg/m2 undergoing cesarean delivery for any cause and willing to have a 2 week post operative follow-up for a wound evaluation at Tufts Medical Center.
Who cannot join
- Women less than age 18, women with an active infection in the location of Pfannenstiel skin incision, women not willing to come to Tufts Medical Center for a wound evaluation 2 weeks post operatively, women who do not have height and weight information available, and women with a BMI < 40 kg/m2 will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial: Do Single Use Negative Pressure Dressings Reduce Wound Complications in Women With a BMI >40 kg/m2 Undergoing Cesarean Delivery at a Tertiary Medical Center?
The investigators aim to show that single use negative pressure dressings can decrease the rate of wound complications in obese women (BMI > 40 kg/m2) undergoing cesarean delivery at a tertiary medical center by randomizing women to receive either a single use negative pressure dressing or the standard dressing after cesarean delivery.
Read the detailed description
Subjects admitted to L+D for obstetric or medical indications at a tertiary medical center with a BMI > 40 kg/m2 will be asked to participate in a study on post surgical dressings and wound outcomes if they undergo cesarean delivery. Subjects will be randomized to either study arm at the time of fascial closure during cesarean delivery. Post operative care will not be altered. Incisions will be evaluated prior to hospital discharge. Subjects will present for a wound evaluation 2 weeks post operatively, and receive phone calls to assess outcomes at both 2 and 6 weeks post operatively.
- Being tested
- Standard Dressing, Negative Pressure Wound Therapy Dressing
- Keywords
- negative pressure wound therapy, cesarean delivery
- Medical subject headings
- Obesity, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard DressingDevice
Patients are randomized to the standard dressing at the time of fascial closure.
Negative Pressure Wound Therapy DressingDevice
Patients are randomized to the NPWT at the time of fascial closure.
| Study group | Role | What they receive |
|---|---|---|
| Standard Dressing | Active comparator | Women will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery. Receives: Device: Standard Dressing |
| Negative Pressure Wound Therapy Dressing | Experimental | Women will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery. Receives: Device: Negative Pressure Wound Therapy Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed by the Two Week Post Operative Appointment
Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation >1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.
Measured: 2 weeks post partum/post operative period
Secondary outcomes (5)
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment
The presence of each the following individual wound complications will be analyzed as separate outcomes: superficial, deep, and organ space SSIs, skin blisters around the incision, scar separation >1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.
Measured: 2 weeks post partum/post operative period
Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed by the Two Week Post Operative Appointment
Composite outcome of the presence of one of the following major complications; deep incisional SSIs, scar separation > 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional operating room management.
Measured: 2 weeks post partum/post operative period
Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed at a Two Week Post Operative Appointment, or Ascertained Through Patient Phone Calls at 2 and 6 Weeks Post Operatively.
Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation >1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.
Measured: 6 weeks post partum/post operative period
Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively
The presence of each the following individual wound complications will be analyzed as separate outcomes: superficial, deep, and organ space SSIs, skin blisters around the incision, scar separation >1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.
Measured: 6 weeks post partum/post operative period
Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Week Post Operatively
Composite outcome of the presence of one of the following major complications; deep incisional SSIs, scar separation > 1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital readmission and additional operating room management.
Measured: 6 weeks post partum/post operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startMay 2016
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael House, MD, Principal investigator, Tufts Medical Center, physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799667
- Sponsor's protocol ID
- 11943
- Status last verified
- Feb 2021
- First submitted
- 20 May 2016
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Peterson AT, Bakaysa SL, Driscoll JM, Kalyanaraman R, House MD. Randomized controlled trial of single-use negative-pressure wound therapy dressings in morbidly obese patients undergoing cesarean delivery. Am J Obstet Gynecol MFM. 2021 Sep;3(5):100410. doi: 10.1016/j.ajogmf.2021.100410. Epub 2021 May 28.
PubMed 34058423
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: Do Single Use Negative Pressure Dressings Reduce Wound Complications in Women With a BMI >40 kg/m2 Undergoing Cesarean Delivery at a Tertiary Medical Center?
- ClinicalTrials.gov ID
- NCT02799667
- Acronym / sponsor ID
- 11943
- Keywords
- negative pressure wound therapy, cesarean delivery
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to show that single use negative pressure dressings can decrease the rate of wound complications in obese women (BMI > 40 kg/m2) undergoing cesarean delivery at a tertiary medical center by randomizing women to receive either a single use negative pressure dressing or the standard dressing after cesarean delivery.
Detailed description
Subjects admitted to L+D for obstetric or medical indications at a tertiary medical center with a BMI > 40 kg/m2 will be asked to participate in a study on post surgical dressings and wound outcomes if they undergo cesarean delivery. Subjects will be randomized to either study arm at the time of fascial closure during cesarean delivery. Post operative care will not be altered. Incisions will be evaluated prior to hospital discharge. Subjects will present for a wound evaluation 2 weeks post operatively, and receive phone calls to assess outcomes at both 2 and 6 weeks post operatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dressing | Active comparator | Device: Standard DressingWomen will be randomized to receive the standard dressing (sterile gauze, non absorbent sterile gauze, and a waterproof bandage) at the time of fascial closure in a cesarean delivery. |
| Negative Pressure Wound Therapy Dressing | Experimental | Device: Negative Pressure Wound Therapy DressingWomen will be randomized to receive the Negative Pressure Wound Therapy (NPWT) dressing at the time of fascial closure in a cesarean delivery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI >40 kg/m2 undergoing cesarean delivery for any cause and willing to have a 2 week post operative follow-up for a wound evaluation at Tufts Medical Center.
Key exclusion criteria (1 listed)
- Women less than age 18, women with an active infection in the location of Pfannenstiel skin incision, women not willing to come to Tufts Medical Center for a wound evaluation 2 weeks post operatively, women who do not have height and weight information available, and women with a BMI < 40 kg/m2 will be excluded from this study.
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 |
|---|---|---|
| Standard DressingPatients are randomized to the standard dressing at the time of fascial closure. | Device | Standard Dressing |
| Negative Pressure Wound Therapy DressingPatients are randomized to the NPWT at the time of fascial closure. | Device | Negative Pressure Wound Therapy Dressing |
Primary outcome
Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed by the Two Week Post Operative Appointment
Time frame: 2 weeks post partum/post operative period
Composite outcome of wound complications, defined as the presence of any of the following: superficial, deep, and organ space surgical site infections (SSIs), skin blisters around the incision, scar separation >1 cm, seroma requiring evacuation, hematoma requiring evacuation, wound debridement, hospital re-admission, and additional operating room management.
5 secondary outcomes
Number of Participants With Individual Wound Complications Diagnosed by the Two Week Post Operative Appointment
Time frame: 2 weeks post partum/post operative period
Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed by the Two Week Post Operative Appointment
Time frame: 2 weeks post partum/post operative period
Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed at a Two Week Post Operative Appointment, or Ascertained Through Patient Phone Calls at 2 and 6 Weeks Post Operatively.
Time frame: 6 weeks post partum/post operative period
Number of Participants With Individual Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Weeks Post Operatively
Time frame: 6 weeks post partum/post operative period
Number of Participants With Composite Outcome of the Presence of Severe Wound Complications Diagnosed at a Two Week Post Operative Appointment or Ascertained Via Patient Phone Calls at 2 and 6 Week Post Operatively
Time frame: 6 weeks post partum/post operative period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34058423Peterson AT, Bakaysa SL, Driscoll JM, Kalyanaraman R, House MD. Randomized controlled trial of single-use negative-pressure wound therapy dressings in morbidly obese patients undergoing cesarean delivery. Am J Obstet Gynecol MFM. 2021 Sep;3(5):100410. doi: 10.1016/j.ajogmf.2021.100410. Epub 2021 May 28.
- 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.
Michael House, MD principal investigator
Tufts Medical Center, physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Dressing and Negative Pressure Wound Therapy Dressing in people with Obesity and Surgical Site Infections, run by Tufts Medical Center 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 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 21 Feb 2021. 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 21 Feb 2021). 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?
Number of Participants With Composite Outcome of the Presence of Wound Complications Diagnosed by the Two Week Post Operative Appointment (time frame: 2 weeks post partum/post operative period). 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 NCT02799667, 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 21 Feb 2021.