Cesarean Section Complications Clinical Trial
Official title:
PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery.
Verified date | February 2024 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 153 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Long Island Jewish Medical Center | New Hyde Park | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
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Smid MC, Dotters-Katz SK, Grace M, Wright ST, Villers MS, Hardy-Fairbanks A, Stamilio DM. Prophylactic Negative Pressure Wound Therapy for Obese Women After Cesarean Delivery: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Nov;130(5):969-978. doi: 10.1097/AOG.0000000000002259. — View Citation
Strugala V, Martin R. Meta-Analysis of Comparative Trials Evaluating a Prophylactic Single-Use Negative Pressure Wound Therapy System for the Prevention of Surgical Site Complications. Surg Infect (Larchmt). 2017 Oct;18(7):810-819. doi: 10.1089/sur.2017.156. Epub 2017 Sep 8. — View Citation
Yu L, Kronen RJ, Simon LE, Stoll CRT, Colditz GA, Tuuli MG. Prophylactic negative-pressure wound therapy after cesarean is associated with reduced risk of surgical site infection: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 Feb;218(2):200-210.e1. doi: 10.1016/j.ajog.2017.09.017. Epub 2017 Sep 23. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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