Cosmetic Outcomes With Tissue Adhesive (2-octylcyanoacrylate) or Staples in Repeated Cesarean Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2021-07-15

Brief Summary

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Recent clinical trials were developed to test the outcomes of skin closure with tissue adhesive, staples and monofilament synthetic suture after cesarean section with Pfannenstiel incision: both clinical outcomes such as blood loss, surgical site infection, length of postpartum hospitalization, or wound disruption, as well as Patient and Observer Scar Assessment Scale (POSAS) scores 8 weeks after surgery, were comparable between these different skin closure methods.

Despite the available studies are often based on robust methodologies and appropriate assessment scales, most of them were aimed to evaluate cosmetic outcomes in primary cesarean section, whereas data analyses published so far do not allow to draw a firm conclusion about repeated cesarean sections. Based on these elements, the aim of this study is to evaluate cosmetic outcomes after skin closure of Pfannenstiel incision with tissue adhesive or staples in a selected population undergoing repeated cesarean section.

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Detailed Description

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Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center, prospective, randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Staples

Women who underwent repeated cesarean section with skin closure using staples.

Group Type ACTIVE_COMPARATOR

Staples

Intervention Type PROCEDURE

Skin closure using surgical stapler.

Tissue adhesive

Women who underwent repeated cesarean section with skin closure using 2-octylcyanoacrylate tissue adhesive.

Group Type EXPERIMENTAL

Tissue adhesive

Intervention Type PROCEDURE

Skin closure using 2-octylcyanoacrylate tissue adhesive.

Interventions

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Staples

Skin closure using surgical stapler.

Intervention Type PROCEDURE

Tissue adhesive

Skin closure using 2-octylcyanoacrylate tissue adhesive.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Previous cesarean section with Pfannenstiel incision (regardless of the indication, emergency/urgency, weeks of pregnancy and years passed from the previous cesarean section)
* Maternal age 18-45 years
* Singleton pregnancy at 37-41 weeks of gestation (based on first-trimester ultrasound) with a viable fetus

Exclusion Criteria

* History of keloids
* Previous transversal suprapubic scars
* Clinical signs of infection and/or tattoos in the area to be studied
* Known patient hypersensitivity to any of the suture materials used in the protocol
* BMI below 20 or above 30
* Any medical disorder that could affect wound healing, including severe malnutrition, conditions requiring chronic corticosteroid use or immune suppressant, uncontrolled diabetes mellitus (defined as Hemoglobin A1c \> 6%, unbalanced daily glucose measurements, and fasting glucose \>95 mg/dL).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No