A Phase 3 interventional study of PICO Negative Pressure Wound Therapy and Standard Dressing in Cesarean Section Complications, Cesarean Wound; Dehiscence and Cesarean Wound Disruption, sponsored by Northwell Health. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Northwell Health · Phase 3, Interventional, and Prevention
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Among 15 studies in Surgical Wound Dehiscence with a site in United States — 4 open to participants now, 4 under way, none of them phase 3. Surgical Wound Dehiscence · United States.
Among the 15 studies in Surgical Wound Dehiscence with a site in United States, this one is the 3rd largest by enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2019, is the only one in phase 3, and was the 10th registered.
48 studies on the registry are indexed under Surgical Wound Dehiscence; 14 are open to participants now.
Browse Surgical Wound Dehiscence studies →4 of the 15 studies in Surgical Wound Dehiscence with a site in United States are open now. Recruiting first, the newest first:
Reprise Biomedical, Inc. · Sites in United States
Ages 18+
Medaxis, LLC · Sites in United States
Ages 18+
U.S. Wound Registry · Sites in United States
Johns Hopkins University · 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 6 Surgical Wound Dehiscence studies recruiting now, 5 set no upper age limit and 1 stops at 75 or younger; 1 takes children under 18; none take healthy volunteers.
This study: 18 Years to 50 Years · female · healthy volunteers too.
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15 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 2 · Phase 2 1 · Phase 3 2 · Phase 4 2
First in 2005; this study’s year is marked. 2 started in 2019.
This study's enrollment of 153 is above the median of 78 across 37 interventional studies indexed under Surgical Wound Dehiscence.
Median enrollment 54 across the 11 interventional studies, 50,000 across the 3 observational. Of the 8 that completed or were terminated, 5 (63%) have results posted.
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4 of 15 have an industry lead sponsor. The 10 most frequent:
Northwell Health is the lead sponsor of 475 studies on the registry; 107 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 23 (50%) have results posted.
Northwell Health has 1 study filed under Surgical Wound Dehiscence — fewer than ten, so there is no comparison to draw.
1 of the studies in Surgical Wound Dehiscence with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07004764Johns Hopkins UniversityEnhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging. | 2027-09 |
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Among the 15 studies in Surgical Wound Dehiscence with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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A randomized controlled, parallel group, superiority, open-label, single-institution, Phase 3 interventional clinical trial to evaluate clinical outcomes in obese gravidas undergoing elective cesarean delivery whose wounds were dressed with the PICO Negative Pressure Wound Therapy (NPWT) versus the standard dressing. We hypothesize that the PICO NPWT will reduce the incidence of surgical site occurrences and interventions and postoperative readmissions in obese women. The study will compare surgical site occurrences and surgical incision intervention incidence within 42 +/- 10 days post cesarean delivery in obese women who have the current standard-of-care dressing versus the PICO NPWT.
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Pre-operatively assessed to undergo a procedure with a CDC Wound Classification of:
a. 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
Exclusion Criteria:
Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract
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.
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.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
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.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PICO Negative Pressure Wound Therapy (Smith and Nephew Healthcare, Hull, United Kingdom) is a non-significant-risk, FDA Class II, medical device commercially available in the USA. The PICO unit is a single patient use, battery-powered, disposable unit that can provide continuous 80 - 125 mmHg negative pressure over a 5 to 7-day therapy period.
Device: PICO Negative Pressure Wound Therapy
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.
Device: Standard Dressing
The PICO unit is a single patient use, battery-powered, disposable unit that can provide continuous 80 - 125 mmHg negative pressure over a 5 to 7-day therapy period.The dressing is applied to the wound and extra strips are placed over the outside edge to help hold the dressing in place. When the pump is turned on, air is pulled out of the dressing and excess fluid from the wound will start to enter the dressing.
Also known as: PICO 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
Surgical Site Occurrence
The incidence of postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) post Cesarean Section.The incidence of postoperative surgical site occurrences (SSOs) post Cesarean delivery. SSOs include: * Unanticipated local inflammatory response * Prolonged drainage * Fluid collection * Dehiscence * Surgical site infection (SSI)
Time frame: 42 days
Surgical Incision Intervention
Incidence rate of surgical incision intervention (SII) post Cesarean delivery. Interventions include: 1. - Antimicrobials for surgical site infection 2. - Surgical drainage of the incision 3. - Surgical incision packing 4. - Adjunctive negative pressure therapy 5. - Debridement 6. - Re-operation
Time frame: 42 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Apr 2019 to primary completion in Sep 2022, 41 months.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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