Surgical Wound DehiscenceNCT00654641
Prevention of Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
A study testing Negative pressure wound closure and Standard wound closure in people with Surgical Wound Dehiscence and Wound Infection, run by West Virginia University at 2 sites in United States.
Trial summary
Wound complications after Cesarean section (C-section) are common in obese women. Approximately 25% of obese women having a C-section will have a wound complication. This research study is designed to assess whether applying a source of vacuum (suction) to the wound can reduce the risk of wound complications. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgical Wound Dehiscence, Wound Infection
- What is being tested?
- Negative pressure wound closure and Standard wound closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2007to Feb 2010
- 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
- Undergoing Cesarean delivery.
- Patient at least 18 years of age.
- Weight greater than 199 pounds.
- Depth of subcutaneous tissue (measured from fascia to epidermis) of greater than or equal to 4 centimeters.
Who cannot join
- Weight less or equal to 199 pounds or less than 4 cm of subcutaneous tissue present.
- Inability to give proper informed consent.
- Inability to adhere to follow-up provisions of the study (return for 2 post-operative visits at 7-14 days post-op and between 4-6 weeks post-op).
- Patient less than 18 years of age.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CAMC Women and Children's Hospital
Charleston, West Virginia, 25304
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: Prevention of Abdominal Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
Wound complications after Cesarean section (C-section) are common in obese women. Approximately 25% of obese women having a C-section will have a wound complication. This research study is designed to assess whether applying a source of vacuum (suction) to the wound can reduce the risk of wound complications. The investigators plan to enroll 220 women into the study.
Women will be randomly selected to receive standard stitching and stapling of the incision (cut on the abdomen) or closure with stitches, staples and wound suction. Subjects will be seen for follow-up visits in 7-14 days and again at 4-6 weeks after surgery. The number of wound complications in each group will be compared. If the wound suction technique is successful in preventing wound complications, this may substantially reduce pain and suffering in a large number of women undergoing C-section for delivery.
- Conditions
- Surgical Wound Dehiscence, Wound Infection
- Being tested
- Negative pressure wound closure, Standard wound closure
- Keywords
- Surgical Wound Dehiscence, Wound Infection, Obesity, Cesarean Delivery, Wound Closure, Negative Pressure wound closure
- Medical subject headings
- Surgical Wound Dehiscence, Wound Infection, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure wound closureProcedure or surgery
Applying negative pressure to primary wound closure
Standard wound closureProcedure or surgery
Standard wound closure
| Study group | Role | What they receive |
|---|---|---|
| Negative pressure wound closure | Experimental | Negative Pressure wound closure Receives: Procedure: Negative pressure wound closure |
| Standard wound closure | Active comparator | Standard Wound Closure Receives: Procedure: Standard wound closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Patients Experiencing a Wound Complication
Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma.
Measured: 6 Weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2008 (estimated)
- Study startSep 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: Poor enrollment. No apparent treatment effect.
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 Surgical Wound DehiscenceStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- CAMC Health System
- Responsible party
- Principal investigator, Michael Stitely, West Virginia University
- Investigators
- Michael L Stitely, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654641
- Sponsor's protocol ID
- H-20292
- Status last verified
- Dec 2012
- First submitted
- 2 Apr 2008
- Last updated
- 30 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Abdominal Wound Complications After Cesarean Delivery in Obese Women Utilizing Negative Pressure Wound Therapy
- ClinicalTrials.gov ID
- NCT00654641
- Acronym / sponsor ID
- H-20292
- Conditions
- Surgical Wound Dehiscence, Wound Infection
- Keywords
- Surgical Wound Dehiscence, Wound Infection, Obesity, Cesarean Delivery, Wound Closure, Negative Pressure wound closure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment. No apparent treatment effect.
- Enrolment
- 54 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- CAMC Health System
- Study start
- Sep 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 8 Apr 2008 (estimated)
- Results
- Posted 30 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Wound complications after Cesarean section (C-section) are common in obese women. Approximately 25% of obese women having a C-section will have a wound complication. This research study is designed to assess whether applying a source of vacuum (suction) to the wound can reduce the risk of wound complications. The investigators plan to enroll 220 women into the study.
Women will be randomly selected to receive standard stitching and stapling of the incision (cut on the abdomen) or closure with stitches, staples and wound suction. Subjects will be seen for follow-up visits in 7-14 days and again at 4-6 weeks after surgery. The number of wound complications in each group will be compared. If the wound suction technique is successful in preventing wound complications, this may substantially reduce pain and suffering in a large number of women undergoing C-section for delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative pressure wound closure | Experimental | Procedure: Negative pressure wound closureNegative Pressure wound closure |
| Standard wound closure | Active comparator | Procedure: Standard wound closureStandard Wound Closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing Cesarean delivery.
- Patient at least 18 years of age.
- Weight greater than 199 pounds.
- Depth of subcutaneous tissue (measured from fascia to epidermis) of greater than or equal to 4 centimeters.
Key exclusion criteria (4 listed)
- Weight less or equal to 199 pounds or less than 4 cm of subcutaneous tissue present.
- Inability to give proper informed consent.
- Inability to adhere to follow-up provisions of the study (return for 2 post-operative visits at 7-14 days post-op and between 4-6 weeks post-op).
- Patient less than 18 years of age.
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 closureApplying negative pressure to primary wound closure | Procedure or surgery | Negative pressure wound closure |
| Standard wound closureStandard wound closure | Procedure or surgery | Standard wound closure |
Primary outcome
Total Number of Patients Experiencing a Wound Complication
Time frame: 6 Weeks post-partum
Superficial or deep space surgical site infection, or any type of wound disruption, including wound hematoma or seroma.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
- 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.
Michael L Stitely, MD principal investigator
West Virginia University
2 sites 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 closure and Standard wound closure in people with Surgical Wound Dehiscence and Wound Infection, run by West Virginia University at 2 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 4 inclusion and 4 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 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2013). 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?
Total Number of Patients Experiencing a Wound Complication (time frame: 6 Weeks post-partum). 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 30 Jan 2013.