What side effects are associated with this type of intervention?

Common treatments for obesity, particularly in the context of surgical interventions such as cesarean delivery, include various wound closure techniques like staples and subcuticular sutures. Known side effects of these treatments can include wound infection, seroma formation, and differences in cosmetic outcomes. Studies have shown that there is no significant difference in long-term cosmetic appearance between using staples and subcuticular sutures. Additionally, suturing the subcutaneous fat does not provide an advantage in preventing wound complications. Proper wound management and postoperative care are crucial to minimize these side effects.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of obesity, which can be relevant for improving surgical outcomes in obese patients. These include orlistat (Xenical), which reduces fat absorption; phentermine-topiramate (Qsymia), which suppresses appetite; naltrexone-bupropion (Contrave), which affects the central nervous system to reduce hunger; and liraglutide (Saxenda), which mimics a hormone that regulates appetite. These treatments aim to assist in weight loss and management, potentially leading to better wound healing and recovery in surgical patients, including those undergoing cesarean delivery.

What other types of research exist?

Promising novel alternatives to staples and subcuticular sutures for skin closure in Class III obese women undergoing cesarean delivery include the use of barbed sutures and tissue adhesive glues. Barbed sutures can provide even tension distribution and reduce closure time, while tissue adhesives can minimize infection risk and improve cosmetic outcomes. Both methods have shown potential in enhancing wound healing and recovery.

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Skin Closure Methods for Cesarean Section in Obese Women

N/A

Waitlist Available

Led By Jennifer McNulty, MD

Research Sponsored by MemorialCare Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of hospital discharge and at 2 weeks postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two methods of closing the skin after a cesarean section in very obese women. It found no difference in wound complications between using staples and using special stitches. More research is needed to find the best method for this high-risk group.

Who is the study for?

This trial is for women over 18 years old with a BMI of at least 40 kg/m2 who are undergoing cesarean delivery. Participants must be able to return for a wound check within 7-14 days after leaving the hospital. Women with hypersensitivity to steri-strips, HIV/AIDS, current cancer treatment or history of radiation to the abdomen/pelvis, or active lupus flare cannot join.

What is being tested?

The study aims to find out which skin closure method is better for Class III obese women having cesarean deliveries: using absorbable subcuticular sutures (stitches that dissolve) or stainless steel staples.

What are the potential side effects?

Possible side effects include reactions at the site of closure such as pain, redness, swelling, infection and scarring. There may also be differences in healing times and cosmetic outcomes between the two methods.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of surgery and hospitalization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of surgery and hospitalization

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of surgery and hospitalization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum

Secondary study objectives

Change in Hemoglobin (Pre-delivery and Post-delivery)

Neonatal Birthweight

Number of Participants According to Skin Incision

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Stainless steel staplesActive Control1 Intervention

Patients in this arm will receive stainless steel staples for skin closure at time of cesarean delivery (CD).

Group II: Absorbable subcuticular SutureActive Control1 Intervention

Patients will receive absorbable subcuticular suture for skin closure at time of cesarean delivery (CD).

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity, such as Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG), work by reducing the stomach's size and altering the digestive tract to limit food intake and nutrient absorption. These mechanisms are vital for obesity patients as they lead to significant weight loss, improve metabolic conditions like type 2 diabetes, and reduce the risk of obesity-related health issues. Additionally, optimizing wound healing techniques, such as comparing staples versus subcuticular sutures, is essential for minimizing postoperative complications and promoting faster recovery in obese patients undergoing surgical procedures.