Stratafix vs. PDS (Fascial Closure RCT)
1 maj 2026 uppdaterad av: Kathleen Curley, University of Arizona
A Randomized Controlled Trial Comparing Stratafix vs. PDS Suture for Fascial Closure at Cesarean Delivery: Impact on Postoperative Pain and Narcotic Use
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).
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
200
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Anna Valencia, MPH
- Telefonnummer: 520-780-8241
- E-post: atvalencia@email.arizona.edu
Studera Kontakt Backup
- Namn: Stephanie Marsh Marsh, MPH
- Telefonnummer: 602-255-7552
- E-post: slmarsh@email.arizona.edu
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: PDS
Polydioxanone
|
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.
|
|
Aktiv komparator: Stratafix
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative Pain Score
Tidsram: 24 hours, 48 hours, and two weeks postpartum
|
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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Length of hospital stay
Tidsram: First 48 hours after surgery
|
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).
|
First 48 hours after surgery
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Kathleen Curley, MD, University of Arizona
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010 Summer;3(3):82-91.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Martin JA, Hamilton BE, Osterman MJ. Births in the United States, 2021. NCHS Data Brief. 2022 Aug;(442):1-8.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 maj 2026
Primärt slutförande (Beräknad)
31 december 2031
Avslutad studie (Beräknad)
31 december 2031
Studieregistreringsdatum
Först inskickad
1 maj 2026
Först inskickad som uppfyllde QC-kriterierna
1 maj 2026
Första postat (Faktisk)
7 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 maj 2026
Senast verifierad
1 mars 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- STUDY00007603
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
There is not a plan to make IPD available.
Läkemedels- och apparatinformation, studiedokument
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Nej
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