Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery

ConditionPregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorInova Health Care Services

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-50 years of age

Women ≥ 24 weeks viable gestation

Will be undergoing cesarean delivery

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Subcuticular monocryl suture

    Procedure/Surgery

    Under the skin suture placed by hand

  • Subcuticular absorbable staple using Insorb device

    Device

    Under the skin stapling device that delivers absorbable staples

Treatment groups

237 Participants
are divided into 2 treatment groups
Group A: Suture wound closureActive comparator 1 intervention
Group B: Absorbable staple wound closureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Operating time

Total time for the procedure

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

Secondary outcomes

1

Wound Cosmesis

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.

Time frame
Up to six weeks post partum
2

Post Operative Pain

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.

Time frame
up to 3 days post-operatively

Other outcomes

1

Number of Adverse Events

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

Time frame
Up to 6 weeks post-partum
2

Number of participants with any unscheduled postpartum visit

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

Time frame
up to 30 days post-operatively
3

Skin Closure Time in Minutes

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

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

Sponsors and contacts

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