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

Obesity Clinical Trial

Official title:

Staples Compared With Subcuticular Suture for Skin Closure After Cesarean Delivery in Obese Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01820221
• Other study ID #: 138350
• Status: Terminated
• Phase: N/A
• First received: March 19, 2013
• Last updated: February 2, 2017
• Start date: March 2013
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 148
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pregnancy

Intervention

Procedure:
• Suture vs. staples closure method after c-section in obese women.
Random card draw to either suture skin closure or staple skin closure arm of study.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).; 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.; 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	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.	72 hours postpartum