Clinical trial NCT01211600: Cesarean Trial of Staples vs. Sutures
Official title: Cesarean Randomized Control Trial Of Sutures vs. Staples (CROSS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Wound Complications
Patient Satisfaction
Pain Measurement
Keywords: Staples
Sutures
Wound infections
Cosmesis
Aesthetic appearance of skin incision
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Main Line Health
First posted: 2010-09-29
Enrollment: 746
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Wound Complications
timeFrame: Within 6 weeks of postpartum
Secondary outcomes:
measure: Patient Scar Assessment Scale Scores for Evaluation of Cosmesis
timeFrame: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.
measure: Patient Satisfaction With Closure Method and Scar Appearance
timeFrame: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.
measure: Pain Perception
timeFrame: Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean
measure: Additional Provider Visits
timeFrame: Within 6 weeks postpartum
measure: Number of Participants With Primary Versus Repeat Cesarean
timeFrame: At randomization.
measure: Intraoperative Trial Details - Duration of Operation and Skin Closure
timeFrame: Time of Cesarean
measure: Intraoperative Trial Details - Closure of Subcutaneous Tissue
timeFrame: Time of Cesarean
measure: Length of Hospital Stay
timeFrame: Immediate postpartum.
measure: Number of Participants That Received Anticoagulation Within 24 Hours
timeFrame: Within 24 hours postpartum.
measure: Number of Participants Diagnosed With Endomyometritis
timeFrame: Immediate postpartum.
measure: Change in Hemoglobin Pre-operatively to Post-operatively
timeFrame: Up to 72 hours before and 24 hours after cesarean.
measure: Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures.
timeFrame: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: A. Dhanya Mackeen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rousseau JA, Girard K, Turcot-Lemay L, Thomas N. A randomized study comparing skin closure in cesarean sections: staples vs subcuticular sutures. Am J Obstet Gynecol. 2009 Mar;200(3):265.e1-4. doi: 10.1016/j.ajog.2009.01.019.
citation: Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.
citation: Alderdice F, McKenna D, Dornan J. Techniques and materials for skin closure in caesarean section. Cochrane Database Syst Rev. 2003;(2):CD003577. doi: 10.1002/14651858.CD003577.
citation: Basha SL, Rochon ML, Quinones JN, Coassolo KM, Rust OA, Smulian JC. Randomized controlled trial of wound complication rates of subcuticular suture vs staples for skin closure at cesarean delivery. Am J Obstet Gynecol. 2010 Sep;203(3):285.e1-8. doi: 10.1016/j.ajog.2010.07.011.
citation: Mackeen AD, Khalifeh A, Fleisher J, Han C, Leiby B, Berghella V. Pain Associated With Cesarean Delivery Skin Closure: A Randomized Controlled Trial. Obstet Gynecol. 2015 Oct;126(4):702-707. doi: 10.1097/AOG.0000000000001043.
citation: Mackeen AD, Khalifeh A, Fleisher J, Vogell A, Han C, Sendecki J, Pettker C, Leiby BE, Baxter JK, Sfakianaki A, Berghella V. Suture compared with staple skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1169-1175. doi: 10.1097/AOG.0000000000000227.