Not yet recruiting NCT07574086

Stratafix vs. PDS (Fascial Closure RCT)

No phase Interventional Pain Score Reduction Cesarian Section

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Polydioxanone Plus, Polydioxanone (PDS).
Who it may be relevant to: Registry conditions: Pain Score Reduction, Cesarian Section. Basic parameters: 18 years — 45 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized Controlled Trial Comparing Stratafix vs. PDS Suture for Fascial Closure at Cesarean Delivery: Impact on Postoperative Pain and Narcotic Use

Overview

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).

Detailed description

This prospective, randomized, single-blinded controlled trial will compare Stratafix™ 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.

Interventions

Device Polydioxanone Plus
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
Device Polydioxanone (PDS)
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.

Primary outcome measures

Postoperative Pain Score [Time frame: 24 hours, 48 hours, and two weeks postpartum]

Secondary outcome measures (1)

Length of hospital stay [Time frame: First 48 hours after surgery]

Eligibility criteria

Inclusion criteria

Women of reproductive age ( ≥18 years old to ≤ 45 years old) undergoing primary scheduled or unscheduled Cesarean delivery at ≥37 weeks of gestation.

Exclusion criteria

Women of reproductive age (≤ 18 years old to ≥ 45 years old) undergoing primary scheduled or unscheduled Cesarean delivery at ≤ 37 weeks of gestation.
Emergent Cesarean delivery
Chronic opioid use or pain disorders
Allergy to suture materials
Previous classical Cesarean section
Intraoperative complications (e.g. hemorrhage, uterine rupture, injury)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Triple blind
Primary purpose: Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

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.2020.02.03 PMID 32113031
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. PMID 14499431
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. PMID 34412076
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. PMID 35533955
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. PMID 31549236
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. PMID 29082807
Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010 Summer;3(3):82-91. PMID 21364859
Martin JA, Hamilton BE, Osterman MJ. Births in the United States, 2021. NCHS Data Brief. 2022 Aug;(442):1-8. PMID 36043891

Identifiers

NCT: NCT07574086 · STUDY00007603

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗