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Recruiting NCT07686913

Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions

No phase Interventional Cesarean Section Surgical Site Infection Wound Dehiscence Seroma

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: Steri-Strip™ Skin Closures, Standard Cesarean Wound Closure.
Who it may be relevant to
Registry conditions: Cesarean Section, Surgical Site Infection, Wound Dehiscence, Seroma. Basic parameters: from 18 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
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Randomized Prospective Trial Comparing Steri-Strip Application Versus Standard Wound Closure for Cesarean Section Incisions

Overview

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.

Interventions

  • Device Steri-Strip™ Skin Closures
    Application of Steri-Strip adhesive skin closure strips following standard cesarean section wound closure according to a standardized protocol.
  • Procedure Standard Cesarean Wound Closure
    Standard skin closure performed following cesarean delivery according to institutional practice.

Primary outcome measures

  • Incidence of Cesarean Section Wound Complications [Time frame: Within 30 days postpartum]
Secondary outcome measures (3)
  • Length of Hospital Stay [Time frame: From cesarean delivery until hospital discharge (up to 7 days)]
  • Readmission Related to Wound Complications [Time frame: Within 30 days postpartum]
  • Cost of Wound Management [Time frame: From cesarean delivery through 30 days postpartum]

Eligibility criteria

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

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Riverside University Health System Medical Center — Moreno Valley

Publications

  • 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. PMID 40114334
  • 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. PMID 40821899
  • 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. PMID 40833607
  • 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. PMID 15295247
  • 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. PMID 39234130

Identifiers

NCT: NCT07686913 · 2357408

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗