Stratafix vs. PDS (Fascial Closure RCT)

NCT07574086 | Not Yet Recruiting

• 1 other identifier: STUDY00007603
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Pain Score Reduction; Cesarian Section

Keywords

Cesarian Section; Pain Score Reduction; Opiod use

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Length of hospital stay

  First 48 hours after surgery

Study Arms (2)

PDS

ACTIVE COMPARATOR

Polydioxanone

Device: Polydioxanone (PDS)

Stratafix

ACTIVE COMPARATOR

Polydioxanone Plus

Device: Polydioxanone Plus

Interventions

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

Stratafix

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.

PDS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Arizona: lead

Related Publications (8)

• 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.

  PMID: 32113031 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.

  PMID: 14499431 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.

  PMID: 34412076 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.

  PMID: 35533955 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.

  PMID: 31549236 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.

  PMID: 29082807 BACKGROUND

• Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010 Summer;3(3):82-91.

  PMID: 21364859 BACKGROUND

• Martin JA, Hamilton BE, Osterman MJ. Births in the United States, 2021. NCHS Data Brief. 2022 Aug;(442):1-8.

  PMID: 36043891 BACKGROUND

Study Officials

• Kathleen Curley, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Valencia, MPH

CONTACT

520-780-8241; atvalencia@email.arizona.edu

Stephanie Marsh Marsh, MPH

CONTACT

602-255-7552; slmarsh@email.arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: May 7, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share