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

NCT07686913 | Recruiting FDA Device

• 1 other identifier: 2357408
• Study Type: interventional
• Target: 610
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section; Surgical Site Infection; Wound Dehiscence; Seroma

Keywords

Cesarean Section; Cesarean Delivery; C-Section; Steri-Strips; Skin Closure; Wound Closure; Surgical Site Infection; Wound Dehiscence; Seroma; Postoperative Wound Complications; Obstetric Surgery; Incision Management; Surgical Wound Healing; Maternal Morbidity; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Incidence of Cesarean Section Wound Complications

  Composite incidence of postoperative wound complications including surgical site infection, wound seroma, and wound separation/dehiscence following cesarean delivery.

  Within 30 days postpartum

Secondary Outcomes (3)

• Length of Hospital Stay

  From cesarean delivery until hospital discharge (up to 7 days)

• Readmission Related to Wound Complications

  Within 30 days postpartum

• Cost of Wound Management

  From cesarean delivery through 30 days postpartum

Study Arms (2)

Standard Closure + Steri-Strips

EXPERIMENTAL

Participants undergo standard cesarean skin closure followed by application of Steri-Strip™ skin closure strips according to a standardized study protocol.

Device: Steri-Strip™ Skin Closures; Procedure: Standard Cesarean Wound Closure

Standard Closure Alone

ACTIVE COMPARATOR

Participants undergo standard cesarean skin closure without application of Steri-Strip™ skin closure strips.

Procedure: Standard Cesarean Wound Closure

Interventions

Steri-Strip™ Skin Closures DEVICE

Application of Steri-Strip adhesive skin closure strips following standard cesarean section wound closure according to a standardized protocol.

Standard Closure + Steri-Strips

Standard Cesarean Wound Closure PROCEDURE

Standard skin closure performed following cesarean delivery according to institutional practice.

Standard Closure + Steri-Strips; Standard Closure Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riverside University Health System Medical Center: lead

Study Sites (1)

Riverside University Health System Medical Center

Moreno Valley, California, 92555, United States

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection; Seroma

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation

Central Study Contacts

Matthew Perera, DO, MS

CONTACT

8184800214; matthew.perera@ruhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Neither participants nor treating clinicians will be blinded to treatment allocation because Steri-Strip application is readily visible following surgery.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Model Details: Participants will be assigned using 1:1 block randomization to one of two study arms. The intervention arm will receive Steri-Strip application following standard cesarean wound closure, while the control arm will receive standard wound closure alone. Participants will remain in their assigned group throughout the study, and outcomes will be assessed within 30 days postpartum.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 7, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)