Sutures vs. Staples Skin Closure After C-section in Obese Patients

N/ATerminatedNCT01820221

University of Arkansas148 enrolled

Overview

This is a randomized prospective clinical trial designed to determine the wound complication rates for stainless steel staples versus subcuticular suture for skin closure in the obese parturient (BMI≥ 30kg/m2) undergoing cesarean delivery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

148

Conditions

Obesity Pregnancy

Interventions

Suture vs. staples closure method after c-section in obese women.PROCEDURE

Random card draw to either suture skin closure or staple skin closure arm of study.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: * 18 years or older * BMI ≥ 30kg/m2 on admission to labor and delivery * Patient is for scheduled cesarean delivery or in non-emergent labor but has an indication for cesarean delivery * Singleton pregnancies * Gestational age ≥ 24weeks * Cesarean delivery performed under regional anesthesia Exclusion criteria: * Refusal to participate * BMI \< 30kg/m2 * \< 24 weeks gestation * Intrauterine fetal demise * Chronic pain syndrome requiring chronic narcotic use * Emergent clinical situations which preclude obtaining informed consent

Locations (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Wound complication rates

Wound complications will be classified as minor and major and the major complications will be further stratified as Seroma, Hematoma and Wound Infection/Surgical site infection (SSI). 1. Minor wound disruption: any wound disruption that DOES not require that the incision be opened, evacuated, irrigated or debrided. There is no evidence of infection including erythema, induration or purulent material. No antibiotic therapy is given. 2. Major wound disruption requires that incision be opened, evacuated, and or irrigated or debrided and includes: * Seroma: collection of serous fluid in the wound without evidence of infection * Hematoma: Demonstrable blood clot between the rectus fascia and the skin * Infection: Any wound that drains purulent material and shows at least 2 of the classic signs of infection; induration, erythema, tenderness, fever. Wound infections will be further classified as superficial or deep.

Time frame: 6 weeks postpartum

Secondary Outcomes

Post-operative pain

To allow for adequate monitoring and assessment of postoperative pain, standardized postoperative pain analgesia protocol at our institution will be followed. This comprises of non-steroidal anti- inflammatory drugs and Narcotics as needed. Patients will be asked to complete a visual analog pain scale ranging from 0-10 on postoperative day 2. Information on use of pain medication during hospitalization and frequency will also be collected from the medical record.

Time frame: 72 hours postpartum

Data from ClinicalTrials.gov

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