An interventional study of Prevena negative pressure wound system in Major Puerperal Infection, Postpartum, Wound Complications and Wound Seroma, sponsored by Abbey Hardy-Fairbanks. Completed at 1 site in United States. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-04-18.
Sponsored by Abbey Hardy-Fairbanks · Not applicable, Interventional, and Prevention
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Among 85 studies in Wound Infection with a site in United States — 8 open to participants now, 9 under way, 2 of them phase 3. Wound Infection · United States.
Among the 85 studies in Wound Infection with a site in United States, this one is the 42nd largest by enrollment of the 78 interventional ones that give a count, is one of 6 that started in 2012, is one of 35 with no phase, and was the 35th registered.
270 studies on the registry are indexed under Wound Infection; 33 are open to participants now.
Browse Wound Infection studies →8 of the 85 studies in Wound Infection with a site in United States are open now. Recruiting first, the newest first:
Brigham and Women's Hospital · Sites in United States
Ages 18+
Major Extremity Trauma Research Consortium · Sites in United States
Ages 18+
University of Pittsburgh · Sites in United States
Ages 18+
University of Texas Southwestern Medical Center · Sites in United States
Ages 18+ · Women only · Healthy volunteers
Major Extremity Trauma Research Consortium · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 23 Wound Infection studies recruiting now, 17 (74%) set no upper age limit and 1 (4%) stops at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 55 Years · female · no healthy volunteers.
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85 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 13 · Phase 3 11 · Phase 4 13
First in 1994; this study’s year is marked. 6 started in 2012.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 110 is below the median of 141 across 228 interventional studies indexed under Wound Infection.
Median enrollment 123 across the 78 interventional studies, 62 across the 6 observational. Of the 65 that completed or were terminated, 33 (51%) have results posted.
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17 of 85 have an industry lead sponsor. The 10 most frequent:
Abbey Hardy-Fairbanks is the lead sponsor of 3 studies on the registry; none are open to participants now.
Abbey Hardy-Fairbanks has 1 study filed under Wound Infection — fewer than ten, so there is no comparison to draw.
5 of the studies in Wound Infection with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05699174Phase 3Major Extremity Trauma Research ConsortiumPO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation | 2027-09 |
| NCT07391735Brigham and Women's HospitalPost-Surgery Wound Healing Tracking With MyHealthPal App | 2027-01-01 |
| NCT06189638Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd.Phase II Study to Evaluate Efficacy and Safety of AMP Peptide PL-5 in Mild Infections of Diabetic Foot Ulcers | 2027-04-30 |
| NCT07004764Johns Hopkins UniversityEnhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging. | 2027-09 |
| NCT06218355University of Texas Southwestern Medical CenterIMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine | 2027-09-01 |
Add all 5 to your calendar (.ics) → With an account.
Among the 85 studies in Wound Infection with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This study is aimed at determining whether or not the use of a wound suction device placed on the cesarean incision instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. The study will first look at the infection and wound complication rate in women 6 months prior to the start date of the study by reviewing charts of women who have undergone a cesarean section. The study involves placing a single use, portable wound vacuum over the cesarean section incision and keeping it in place for 72h. The investigators will then compare the rates of wound infection and wound complications between these two groups.
It is our hypothesis that negative pressure wound systems will decrease the wound infection and complication rate in this high risk population.
Infectious complications have been found to be five times higher in women undergoing a cesarean delivery compared to a vaginal delivery. Known risk factors for wound complications are obesity, premature rupture of membranes, diabetes mellitus, hypertensive disorders, emergency cesarean delivery, twin delivery, chorioamnionitis, increased surgical blood loss and preeclampsia.
This study is aimed at determining whether or not the use of a suction device placed on the wound instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. The investigators will compare the results from the participants of this study to an existing data set of historical controls who underwent cesarean delivery. The study involves placing a single use, portable negative wound pressure system kept in place while in the hospital after surgery (on average 48-72 hours) in women who meet criteria for increased risk of wound complications. The investigators will then compare the rates of wound infection and wound complications between these two groups.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Will have the Prevena negative pressure wound system placed at the time of surgery.
Device: Prevena negative pressure wound system
Placement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication
Wound Complication Rate
Wound infection, separation or deep infection
Time frame: Up to 6 weeks from time of surgery
| Milestone | Negative Pressure Pump |
|---|---|
| Started | 110 |
| Completed | 110 |
| Not completed | 0 |
Wound infection, separation or deep infection
| participants | Negative Pressure Pump |
|---|---|
| wound infection | 3 |
| Endometritis | 1 |
| Wound separation | 3 |
| All wound complications (separation and infection) | 6 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Negative Pressure Pump | 0/110 (0%) | 1/110 (0.9%) | 0/110 (0%) |
| Event | Negative Pressure Pump |
|---|---|
| Skin irritationSkin and subcutaneous tissue disorders | 1/110 |
| Age, Categorical(Participants) | Negative Pressure Pump |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 110 |
| >=65 years | 0 |
| Age, Continuous(years) | Negative Pressure Pump |
|---|---|
| Mean | 30.8 ± 6.0 |
| Sex: Female, Male(Participants) | Negative Pressure Pump |
|---|---|
| Female | 110 |
| Male | 0 |
| Region of Enrollment(participants) | Negative Pressure Pump |
|---|---|
| United States | 110 |
The record gives a start of Aug 2012, a primary completion of Feb 2013 and a completion of Feb 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2018, 5 years 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Abbey Hardy-Fairbanks