- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Matthew Perera, DO, MS
- Telefonnummer: 8184800214
- E-post: matthew.perera@ruhealth.org
Studieorter
-
-
California
-
Moreno Valley, California, Förenta staterna, 92555
- Rekrytering
- Riverside University Health System Medical Center
-
Kontakt:
- Matthew X Perera, DO, MS
- Telefonnummer: 8184800214
- E-post: mattpereraruhs@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Aktiv 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of Cesarean Section Wound Complications
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Length of Hospital Stay
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2357408
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .