Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICO Dressing | Experimental | 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. |
|
| Standard Dressing | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICO Negative Pressure Wound Therapy | Device | 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. |
| 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:
| 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Incision Intervention | Incidence rate of surgical incision intervention (SII) post Cesarean delivery. Interventions include:
| 42 days |
Not provided
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:
Class III (Contaminated): Open, fresh, accidental wounds, and/or major breaks in sterile technique or gross spillage from the gastrointestinal tract
Study is being conducted on female postpartum patient.
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gary Goldberg, MD | Long Island Jewish Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27901277 | Background | 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. | |
| 21606770 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 21, 2021 | Feb 27, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 21, 2021 | Feb 27, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013529 | Surgical Wound Dehiscence |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014946 | Wound Infection |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Standard Dressing | Device | 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 |
|
| 28759428 | Background | 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. |
| 25569006 | Background | 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. |
| 26241279 | Background | 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. |
| 23111014 | Background | 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. |
| 21306347 | Background | 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. |
| 18510455 | Background | 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. |
| 27926575 | Background | 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. |
| 28807639 | Background | 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. |
| 29016508 | Background | 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. |
| 28885895 | Background | 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. |
| 28951263 | Background | 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. |
| D007239 | Infections |