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

Not Applicable

Terminated

• Conditions: Obesity; Pregnancy
• Interventions: Procedure: Suture vs. staples closure method after c-section in obese women.

• Registration Number: NCT01820221
• Lead Sponsor: University of Arkansas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-25
• Study First Posted: 2013-03-28
• Status Verified: 2017-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 148

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Skin closure with suture	Suture vs. staples closure method after c-section in obese women.	Subjects in this group will be randomized to suture for skin closure with computer generated random card draw.
Arm 2: Skin closure with staples	Suture vs. staples closure method after c-section in obese women.	Subjects randomized to skin closure with staples with computer generated random card draw.

Primary Outcome Measures

Name	Time	Method
Wound complication rates	6 weeks postpartum	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.

Secondary Outcome Measures

Name	Time	Method
Post-operative pain	72 hours postpartum	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.

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States