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

NCT01820221 | Terminated

• 1 other identifier: 138350
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Pregnancy

Keywords

cesarean delivery; wound complications; skin closure methods

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks postpartum

Secondary Outcomes (1)

• Post-operative pain

  72 hours postpartum

Study Arms (2)

Arm 1: Skin closure with suture

ACTIVE COMPARATOR

Subjects in this group will be randomized to suture for skin closure with computer generated random card draw.

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

Arm 2: Skin closure with staples

ACTIVE COMPARATOR

Subjects randomized to skin closure with staples with computer generated random card draw.

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

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.

Arm 1: Skin closure with suture; Arm 2: Skin closure with staples

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary L Racher, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 28, 2013
• Study Start: March 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

US (1)