PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery.

Study Overview
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Brief Summary
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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.

Official Title
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PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery.

Conditions
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Cesarean Wound; Dehiscence, Cesarean Wound Disruption, Cesarean Section Complications

Intervention / Treatment
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* Device: PICO Negative Pressure Wound Therapy
* Device: Standard Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study; willing and able to return for all scheduled and required study visits Female, aged 18 - 55 years BMI ≥ 35 kg/m2 in the 42 days prior to surgery In good general health as evidenced by medical history with a 24 - 41 weeks gestational age pregnancy scheduled for cesarean delivery for any routine indication (repeat procedure, breech presentation, abnormal placentation, uterine anomaly, maternal medical condition, or elective) Surgical skin site preparation with chlorhexidine gluconate solution (ChloraPrep©) Received preoperative surgical prophylaxis antibiotics as per protocol Surgical incision that can be covered completely by the NPWT skin system 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 OR - b. Class II (Clean Contaminated): An operative wound in which the respiratory, alimentary, genital, or uninfected urinary tract are entered under controlled conditions and without unusual contamination Wound hemostasis has been achieved Exclusion Criteria: Cesarean delivery before fetal viability (24 0/7 weeks gestational age) Unplanned Cesarean delivery Intrauterine fetal demise Known allergic reactions to components of the PICO NPWT system Systemic bacterial or fungal infection at the time of surgery Diagnosis of systemic or remote-site skin infections at time of delivery Treatment with another investigational drug or other intervention within 7 days prior to cesarean delivery or 42 +/- 10 days after cesarean delivery Delivery for suspected intrauterine infection (defined as maternal fever plus one clinical criteria) Critical illness or immune-compromising disease (eg acquired immunodeficiency syndrome) Chronic steroid use Pre-operatively assessed to have a CDC Wound Classification of: Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract OR - Class IV (Dirty-Infected): Old traumatic wounds with retained devitalized tissue and those that involve existing clinical infection or perforated viscera High-risk for anesthesia (American Society of Anesthesiologists [ASA] class P4 - P6) Intra-operative hemorrhage requiring blood transfusion, disseminated-intravascular coagulopathy (DIC) or any other medical or surgical condition during the Cesarean section deemed by the investigator to pose a prohibitively high risk for surgical re-exploration Unable to speak or understand English, with no interpreter available.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PICO Dressing<br>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<br>* 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.<br>* Other names: PICO Dressing;|
| Active Comparator: Standard Dressing<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Incision Intervention | Incidence rate of surgical incision intervention (SII) post Cesarean delivery. Interventions include: - Antimicrobials for surgical site infection - Surgical drainage of the incision - Surgical incision packing - Adjunctive negative pressure therapy - Debridement - Re-operation | 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, negative-pressure wound therapy, surgical wound dehiscence, hospital readmission, surgical site infection