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This proposed prospective, randomized, single-blinded controlled trial will directly compare Stratafix anti-microbial barbed sutures and standard PDS sutures for fascial closure at the time of Cesarean delivery.
Primary outcomes will include postoperative pain scores at 24 hours, 48 hours, and two weeks postpartum (both total pain and right-sided abdominal pain commonly associated with the knot from traditional fascial closure), as well as total opioid consumption (morphine milligram equivalents) for the first 48 hours.
Secondary outcomes will include length of hospital stay, wound complications (e.g., infection, dehiscence), patient satisfaction measured per the standardized surgical satisfaction questionnaire (SSQ-8), time required for fascial closure (minutes from start to end of fascial closure), and surgical site infections. The hypothesis is that among women undergoing primary Cesarean delivery, fascial closure with barbed suture (Stratafix) will result in lower postoperative pain scores and reduced opioid (narcotic) consumption within the first 48 hours after surgery compared to closure with traditional monofilament suture (PDS).
This prospective, randomized, single-blinded controlled trial will compare Stratafixâ„¢ antimicrobial barbed sutures with standard PDS monofilament sutures for fascial closure at Cesarean delivery, evaluating whether barbed sutures improve postoperative recovery. Primary outcomes include postoperative pain scores at 24 hours, 48 hours, and two weeks-capturing both overall pain and the right-sided discomfort often associated with fascial knot placement-as well as total opioid use in the first 48 hours (measured in MMEs). Secondary outcomes include length of hospital stay, wound complications, surgical site infections, fascial closure time, and patient-reported satisfaction using the SSQ-8. The study hypothesizes that barbed suture closure will result in lower pain and reduced opioid consumption compared with traditional PDS closure among women undergoing primary Cesarean delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDS | Active Comparator | Polydioxanone |
|
| Stratafix | Active Comparator | Polydioxanone Plus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polydioxanone Plus | Device | Polydioxanone Plus (PDS) is a standard monofilament, absorbable suture used for fascial closure at the time of Cesarean delivery. In this study, PDS will be used to approximate the rectus fascia in a continuous running fashion with a traditional terminal knot. This intervention represents the conventional method of fascial closure and serves as the control arm for comparison against Stratafix barbed suture |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Score | Primary outcomes will include postoperative pain scores at 24 hours, 48 hours, and two weeks postpartum (both total pain and right-sided abdominal pain commonly associated with the knot from traditional fascial closure), as well as total opioid consumption (morphine milligram equivalents) for the first 48 hours. | 24 hours, 48 hours, and two weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Secondary outcomes will include length of hospital stay, wound complications (e.g., infection, dehiscence), patient satisfaction measured per the standardized surgical satisfaction questionnaire (SSQ-8), time required for fascial closure (minutes from start to end of fascial closure), and surgical site infections. The hypothesis is that among women undergoing primary Cesarean delivery, fascial closure with barbed suture (Stratafix) will result in lower postoperative pain scores and reduced opioid (narcotic) consumption within the first 48 hours after surgery compared to closure with traditional monofilament suture (PDS). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Valencia, MPH | Contact | 520-780-8241 | atvalencia@email.arizona.edu | |
| Stephanie Marsh Marsh, MPH | Contact | 602-255-7552 | slmarsh@email.arizona.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kathleen Curley, MD | University of Arizona | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32113031 | Background | Ruiz-Tovar J, Llavero C, Jimenez-Fuertes M, Duran M, Perez-Lopez M, Garcia-Marin A. Incisional Surgical Site Infection after Abdominal Fascial Closure with Triclosan-Coated Barbed Suture vs Triclosan-Coated Polydioxanone Loop Suture vs Polydioxanone Loop Suture in Emergent Abdominal Surgery: A Randomized Clinical Trial. J Am Coll Surg. 2020 May;230(5):766-774. doi: 10.1016/j.jamcollsurg.2020.02.031. Epub 2020 Feb 27. | |
| 14499431 |
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There is not a plan to make IPD available.
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|
| Polydioxanone (PDS) | Device | Polydioxanone (PDS) is a standard monofilament, absorbable suture used for fascial closure at the time of Cesarean delivery. In this study, PDS will be used to approximate the rectus fascia in a continuous running fashion with a traditional terminal knot. This intervention represents the conventional method of fascial closure and serves as the control arm for comparison against Stratafix barbed suture. |
|
| First 48 hours after surgery |
| Background |
| Cepeda MS, Africano JM, Polo R, Alcala R, Carr DB. What decline in pain intensity is meaningful to patients with acute pain? Pain. 2003 Sep;105(1-2):151-7. doi: 10.1016/s0304-3959(03)00176-3. |
| 34412076 | Background | Pharmacologic Stepwise Multimodal Approach for Postpartum Pain Management: ACOG Clinical Consensus No. 1. Obstet Gynecol. 2021 Sep 1;138(3):507-517. doi: 10.1097/AOG.0000000000004517. |
| 35533955 | Background | Raischer HB, Massalha M, Iskander R, Izhaki I, Salim R. Knotless Barbed versus Conventional Suture for Closure of the Uterine Incision at Cesarean Delivery: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2022 Jul;29(7):832-839. doi: 10.1016/j.jmig.2022.05.001. Epub 2022 May 7. |
| 31549236 | Background | Park SK, Yoon HK, Kim WH. Obesity and spinal anesthesia outcomes. J Anesth. 2019 Dec;33(6):704. doi: 10.1007/s00540-019-02685-7. Epub 2019 Sep 23. No abstract available. |
| 29082807 | Background | Zayed MA, Fouda UM, Elsetohy KA, Zayed SM, Hashem AT, Youssef MA. Barbed sutures versus conventional sutures for uterine closure at cesarean section; a randomized controlled trial. J Matern Fetal Neonatal Med. 2019 Mar;32(5):710-717. doi: 10.1080/14767058.2017.1388368. Epub 2017 Oct 29. |
| 21364859 | Background | Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010 Summer;3(3):82-91. |
| 36043891 | Background | Martin JA, Hamilton BE, Osterman MJ. Births in the United States, 2021. NCHS Data Brief. 2022 Aug;(442):1-8. |