Clinical trial NCT03414762: PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery.
Official title: PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cesarean Section Complications
Cesarean Wound; Dehiscence
Cesarean Wound Disruption
Keywords: cesarean section
negative-pressure wound therapy
surgical wound dehiscence
hospital readmission
surgical site infection
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Surgical Site Occurrence
timeFrame: 42 days
Secondary outcomes:
measure: Surgical Incision Intervention
timeFrame: 42 days
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
Study officials:
affiliation: Long Island Jewish Medical Center
name: Gary Goldberg, MD
role: STUDY_CHAIR
References:
citation: Acosta S, Bjorck M, Wanhainen A. Negative-pressure wound therapy for prevention and treatment of surgical-site infections after vascular surgery. Br J Surg. 2017 Jan;104(2):e75-e84. doi: 10.1002/bjs.10403. Epub 2016 Nov 30.
citation: ACOG Practice Bulletin No. 120: Use of prophylactic antibiotics in labor and delivery. Obstet Gynecol. 2011 Jun;117(6):1472-1483. doi: 10.1097/AOG.0b013e3182238c31. No abstract available.
citation: Bilgi A, Zumrut Biber Muftuler F, Akman L, Ilker Medine E, Tonbaklar Bilgi P, Kozgus Guldu O, Goksun Gokulu S, Tekin V, Cosan Terek M. In Vitro Determination of Wound Healing Potential of Axonge. Wounds. 2017 Jul;29(7):209-214.
citation: Echebiri NC, McDoom MM, Aalto MM, Fauntleroy J, Nagappan N, Barnabei VM. Prophylactic use of negative pressure wound therapy after cesarean delivery. Obstet Gynecol. 2015 Feb;125(2):299-307. doi: 10.1097/AOG.0000000000000634.
citation: Gillespie BM. Prophylactic Use of Negative Pressure Wound Therapy After Cesarean Delivery. Obstet Gynecol. 2015 Jul;126(1):214. doi: 10.1097/AOG.0000000000000937. No abstract available.
citation: Grauhan O, Navasardyan A, Hofmann M, Muller P, Stein J, Hetzer R. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. 2013 May;145(5):1387-92. doi: 10.1016/j.jtcvs.2012.09.040. Epub 2012 Oct 27.
citation: Leth RA, Uldbjerg N, Norgaard M, Moller JK, Thomsen RW. Obesity, diabetes, and the risk of infections diagnosed in hospital and post-discharge infections after cesarean section: a prospective cohort study. Acta Obstet Gynecol Scand. 2011 May;90(5):501-9. doi: 10.1111/j.1600-0412.2011.01090.x. Epub 2011 Mar 14.
citation: Olsen MA, Butler AM, Willers DM, Devkota P, Gross GA, Fraser VJ. Risk factors for surgical site infection after low transverse cesarean section. Infect Control Hosp Epidemiol. 2008 Jun;29(6):477-84; discussion 485-6. doi: 10.1086/587810.
citation: O'Leary DP, Peirce C, Anglim B, Burton M, Concannon E, Carter M, Hickey K, Coffey JC. Prophylactic Negative Pressure Dressing Use in Closed Laparotomy Wounds Following Abdominal Operations: A Randomized, Controlled, Open-label Trial: The P.I.C.O. Trial. Ann Surg. 2017 Jun;265(6):1082-1086. doi: 10.1097/SLA.0000000000002098.
citation: Searle RJ, Myers D. A survey of caesarean section surgical site infections with PICO Single Use Negative Pressure Wound Therapy System in high-risk patients in England and Ireland. J Hosp Infect. 2017 Oct;97(2):122-124. doi: 10.1016/j.jhin.2017.02.023. Epub 2017 Aug 12.
citation: 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.
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.
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.