Overview

This trial is active, not recruiting.

Conditions cesarean section, wound complications, patient satisfaction, pain measurement
Treatments staples, suture
Sponsor Thomas Jefferson University
Collaborator Main Line Health
Start date June 2010
End date October 2014
Trial size 936 participants
Trial identifier NCT01211600, 10D.199

Summary

To determine whether the rate of wound complications differs based on method of closure of skin incision (staples vs. suture) after cesarean delivery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Arm
(Active Comparator)
Interrupted Ethicon Staples
staples Closure Technique
Interrupted Ethicon Staples
(Active Comparator)
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
suture Closure Technique
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)

Primary Outcomes

Measure
Wound complications
time frame: 4 - 8 weeks after intervention of staples or stitches.

Secondary Outcomes

Measure
Cosmesis
time frame: Immediately postpartum and 4 - 8 weeks after intervention.
Patient satisfaction
time frame: Immediately postpartum and 4 - 8 weeks after intervention.
Pain perception
time frame: Immediately postpartum and 4 - 8 weeks after intervention.
Cost
time frame: 4 - 8 weeks after intervention.
Additional provider visits
time frame: 4 - 8 weeks post intervention.
Wound complications - additional analyses
time frame: 4 - 8 weeks after intervention

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - Women undergoing cesarean delivery for pregnancy greater than 23 weeks gestation. Exclusion Criteria: - Poorly controlled diabetes (defined as ≥ 50% of fasting or 2 hour postprandial glucose levels > 95 and 120 respectively within the week prior to delivery), - Vertical skin incisions - Chronic steroid use - Active lupus flare - HIV/AIDS - Current treatment for cancer or a history of radiation to the abdomen/pelvis - Current treatment with immunosuppressant medications secondary to history of transplantation - Emergency cesarean(precluding informed consent prior to surgery) - Lack of access to a phone - Allergy to suture or staple material

Additional Information

Official title Cesarean Randomized Control Trial Of Sutures vs. Staples (CROSS)
Principal investigator A. Dhanya Mackeen, MD, MPH
Description Despite this large number of cesareans performed annually, there is a paucity of data to suggest which technique is superior for closure of the skin incision with regards to wound complications, including wound separation and infection. As the morbidity associated with a cesarean delivery is usually related to wound complications, especially infection, we feel that it is important to examine this outcome by comparing the current skin closure techniques: staples versus suture.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Thomas Jefferson University.