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NCT Number: NCT07167199

Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery

Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location contact

Antonio Saad, MD

CONTACT

[email protected]

706-776-6040

Antonio Saad, MD

PRINCIPAL_INVESTIGATOR

Elle Murrin, MD

SUB_INVESTIGATOR

Maggie Wong, MD

SUB_INVESTIGATOR

Michelle L Cassidy, PhD, RN

CONTACT

[email protected]

(703) 776-4600

About this study

This will be an open-label randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have either standard wound closure with Monocryl suture or absorbable subcuticular staples placed by INSORB skin stapling device. The INSORB under the skin stapling device is FDA approved but not currently used as standard of care at Inova. We will exclude women with intraamniotic infection, immunosuppression, active skin infection, those unlikely to be followed-up after delivery, or unable to provide consent.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-50 years of age
  • Women ≥ 24 weeks viable gestation
  • Will be undergoing cesarean delivery

Exclusion criteria

  • Patient unwilling or unable to provide consent.
  • No or very limited prenatal care or a non-resident patient who is unlikely to follow-up after delivery.
  • Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or other
  • Decision not to have skin closure (e.g. secondary wound closure, mesh closure)
  • Current skin infection
  • Coagulopathy
  • High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, tubal ligation, bowel or adnexal surgery)
  • Incarcerated individuals
  • Intraamniotic infection
  • Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.

Treatment and study plan

Subcuticular monocryl suture

Procedure

Under the skin suture placed by hand

Subcuticular absorbable staple using Insorb device

Device

Under the skin stapling device that delivers absorbable staples

Primary outcomes

  1. Operating time

    Time frame: Time from the start of surgery through end of skin closure up to 8 hours

    Total time for the procedure

Secondary outcomes

  1. Wound Cosmesis

    Time frame: Up to six weeks post partum

    A digital photograph of the incision will be obtained on wound check visit POD 5-10 days and 4-6 weeks post partum. Each photograph will be evaluated by independent blinded research staff using the Stony Brook Scar Evaluation Scale. These scores are totaled to obtain the final score. The Stony Brook Scar Evaluation will score the scar from 0-5 where 5 shows significant healing.

  2. Post Operative Pain

    Time frame: up to 3 days post-operatively

    Analog pain scale ranging from 0-10. This is a standard question that nurses as during the post partum period while in the hospital and clinic/nursing visits. The numerical score will be recorded from the patient's chart.

    A score of 0 means no pain, and 10 means the worst pain.

Other outcomes

  1. Number of Adverse Events

    Time frame: Up to 6 weeks post-partum

    Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis

  2. Number of participants with any unscheduled postpartum visit

    Time frame: up to 30 days post-operatively

    Any additional postpartum clinic appointments for medical or clinical concerns beyond the routinely scheduled visits. Participants are counted once, regardless of number or type of visits

  3. Skin Closure Time in Minutes

    Time frame: Time from start of skin closure to end of skin closure up to 2 hours

    Minutes it takes for closure of the skin at time of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Saad, MD

CONTACT

[email protected]

(703) 779-6040

Michelle L Cassidy, PhD, RN

CONTACT

[email protected]

(703) 776-4600

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Registry information

Official study title

Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery: A Randomized Control Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2025
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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