- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07686913
Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions (STRIP-CS)
A Randomized Prospective Trial Comparing Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions
This study is evaluating whether Steri-Strips® provide additional benefits when used after cesarean section (C-section) surgery. Steri-Strips are adhesive strips that are commonly placed over a surgical incision to provide support while the wound heals. At our hospital, Steri-Strips are routinely used after C-sections in addition to standard wound closure techniques, although they are not considered part of the standard recommended closure method.
Researchers want to determine whether adding Steri-Strips actually reduces wound complications such as infection, fluid collection under the skin, or reopening of the incision. Previous studies have shown mixed results, with some suggesting little difference in wound healing outcomes while others reported differences in scar appearance. Steri-Strips may also increase costs, add time to the surgery, and occasionally cause skin irritation or allergic reactions.
Participants in this study will be randomly assigned to one of two groups. One group will receive standard cesarean wound closure with Steri-Strips, while the other group will receive standard wound closure without Steri-Strips. Researchers will compare wound healing, complications, patient outcomes, and costs between the two groups.
The goal of this study is to determine whether Steri-Strips improve recovery after cesarean delivery and whether their routine use is beneficial and cost-effective. The findings may help guide future recommendations for cesarean wound care and improve outcomes for patients undergoing C-section delivery.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Matthew Perera, DO, MS
- Telefonnummer: 8184800214
- E-Mail: matthew.perera@ruhealth.org
Studienorte
-
-
California
-
Moreno Valley, California, Vereinigte Staaten, 92555
- Rekrutierung
- Riverside University Health System Medical Center
-
Kontakt:
- Matthew X Perera, DO, MS
- Telefonnummer: 8184800214
- E-Mail: mattpereraruhs@gmail.com
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Female patients age 18 years or older
- Pregnant patients undergoing cesarean delivery at Riverside University Health System Medical Center (RUHS)
- Able and willing to provide informed consent
Exclusion Criteria:
- Known allergy or hypersensitivity to Steri-Strip™ materials or adhesives
- Inability or unwillingness to provide informed consent
- Anticipated inability to complete the 30-day postpartum follow-up evaluation
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Standard Closure + Steri-Strips
Participants undergo standard cesarean skin closure followed by application of Steri-Strip™ skin closure strips according to a standardized study protocol.
|
Application of Steri-Strip adhesive skin closure strips following standard cesarean section wound closure according to a standardized protocol.
Standard skin closure performed following cesarean delivery according to institutional practice.
|
|
Aktiver Komparator: Standard Closure Alone
Participants undergo standard cesarean skin closure without application of Steri-Strip™ skin closure strips.
|
Standard skin closure performed following cesarean delivery according to institutional practice.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of Cesarean Section Wound Complications
Zeitfenster: Within 30 days postpartum
|
Composite incidence of postoperative wound complications including surgical site infection, wound seroma, and wound separation/dehiscence following cesarean delivery.
|
Within 30 days postpartum
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Length of Hospital Stay
Zeitfenster: From cesarean delivery until hospital discharge (up to 7 days)
|
Duration of hospitalization measured from cesarean delivery until discharge.
|
From cesarean delivery until hospital discharge (up to 7 days)
|
|
Readmission Related to Wound Complications
Zeitfenster: Within 30 days postpartum
|
Hospital readmission attributable to wound infection, seroma, or wound separation/dehiscence following cesarean delivery.
|
Within 30 days postpartum
|
|
Cost of Wound Management
Zeitfenster: From cesarean delivery through 30 days postpartum
|
Comparison of direct healthcare costs associated with wound closure materials and management of postoperative wound complications between study groups.
|
From cesarean delivery through 30 days postpartum
|
Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Herman A, Kerre S, Stras A, Desmedt B. Two Additional Cases of Allergic Contact Dermatitis Caused by Wound Closure Tape Steri-Strip3M. Contact Dermatitis. 2025 Jul;93(1):68-70. doi: 10.1111/cod.14788. Epub 2025 Mar 20. No abstract available.
- Hall JD, Schwartz E. Solving "T" Junction Wound Breakdown With a Single Tension-reducing Device. Plast Reconstr Surg Glob Open. 2025 Aug 15;13(8):e6882. doi: 10.1097/GOX.0000000000006882. eCollection 2025 Aug.
- Dominoni M, Torella M, Molitierno R, Fordellone M, Saccone G, Colacurci D, Lagana AS, Pano MR, Gardella B, La Verde M. Single-versus double-layer uterine closure at the time of cesarean delivery and risk of uterine scar niche: a systematic review and meta-analysis of randomized trials. Arch Gynecol Obstet. 2025 Oct;312(4):1095-1106. doi: 10.1007/s00404-025-08151-y. Epub 2025 Aug 20.
- Zempsky WT, Parrotti D, Grem C, Nichols J. Randomized controlled comparison of cosmetic outcomes of simple facial lacerations closed with Steri Strip Skin Closures or Dermabond tissue adhesive. Pediatr Emerg Care. 2004 Aug;20(8):519-24. doi: 10.1097/01.pec.0000136068.45198.ae.
- Sah N, Punga R, Kumar A, Shivhare P, Singh AK, Sah S, Shekhar A. The surgical outcome of sutureless skin closures using Octyl-2-cyanoacrylate (Dermabond) versus Steri-Strip. Natl J Maxillofac Surg. 2024 May-Aug;15(2):307-312. doi: 10.4103/njms.njms_102_22. Epub 2024 Jul 24.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- Infektion der Operationsstelle
- Randomisierte, kontrollierte Studie
- Kaiserschnitt
- Kaiserschnitt
- Seroma
- Wundverschluss
- Mütterliche Morbidität
- Hautverschluss
- Kaiserschnitt
- Wunddehiszenz
- Chirurgische Wundheilung
- Geburtshilfliche Operation
- Steri-Strips
- Postoperative Wound Complications
- Incision Management
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2357408
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .