Cesarean Trial of Staples vs. Sutures (CROSS)

Cesarean Randomized Control Trial Of Sutures vs. Staples (CROSS)

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Patient Satisfaction; Pain Measurement; Wound Complications
• Intervention / Treatment: Other: Staples; Other: Suture

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.

• Study Type: Interventional
• Enrollment (Actual): 746
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States
      • Yale University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Staples; Interrupted Ethicon Staples	Other: Staples; Interrupted Ethicon Staples; Other Names: Closure Technique
Active Comparator: Suture; Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)	Other: Suture; Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle); Other Names: Closure Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Wound Complications	The primary outcome is to evaluate the rate of wound complications for patients undergoing cesarean whose skin incision is closed with staples versus with suture. Wound complications included infection, hematoma, seroma, and separation and readmission for wound complication.	Within 6 weeks of postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Scar Assessment Scale Scores for Evaluation of Cosmesis	Patient evaluation of cosmesis of the cesarean incision based on closure method: staples vs sutures. Surgical scars were evaluated using Patient Scar Assessment Scale (PSAS). The PSAS evaluates six items: pain, itchiness, color, stiffness, thickness, and irregularity. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 6-60. Lower scores indicate closer resemblance to normal skin and are superior.	Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.
Patient Satisfaction With Closure Method and Scar Appearance	Whether the patient's satisfaction with the incision differed based on closure method (staples vs sutures) using 10-point Likert scale on which 1 is completely dissatisfied and 10 is completely satisfied.	Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.
Pain Perception	Whether the patient's perception of pain associated with the incision differed based on closure method (staples vs sutures). Patients were asked to rate pain on a scale from 0 (no pain) to 10 (extreme pain) using a visual graph of facial expressions.	Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean
Additional Provider Visits	Mean number of visits per participant (All wound visits, number of visits for women who were diagnosed with wound complications, number of visits for women who were not diagnosed with a wound complication).	Within 6 weeks postpartum
Number of Participants With Primary Versus Repeat Cesarean	Randomization stratum - BMI (over/under 30) and Cesarean (primary or repeat)	At randomization.
Intraoperative Trial Details - Duration of Operation and Skin Closure	Duration of operation: skin incision to skin closure Duration of skin closure: fascial closure to skin closure	Time of Cesarean
Intraoperative Trial Details - Closure of Subcutaneous Tissue	Number of participants requiring subcutaneous tissue closure	Time of Cesarean
Length of Hospital Stay	Length of hospital stay (days)	Immediate postpartum.
Number of Participants That Received Anticoagulation Within 24 Hours	Number of participants that received anticoagulation within 24 hours of procedure (preoperatively or postoperatively)	Within 24 hours postpartum.
Number of Participants Diagnosed With Endomyometritis	Number of participants diagnosed with endomyometritis requiring antibiotics	Immediate postpartum.
Change in Hemoglobin Pre-operatively to Post-operatively	Median change in hemoglobin from preoperative value (g/dL) to post-operatively.	Up to 72 hours before and 24 hours after cesarean.
Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures.	Surgical scars were evaluated using Observer Scar Assessment Scale (OSAS). The OSAS evaluates five items: vascularity, pigmentation, thickness, relief, and pliability. Each item is scored on a 10-point scale comparing the patient's skin to normal skin, in which one represents normal skin. The score is summed, range 5-50. Lower scores indicate closer resemblance to normal skin and are superior.	Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: Main Line Health
• Investigators: Principal Investigator: A. Dhanya Mackeen, MD, MPH, Thomas Jefferson University

Publications and helpful links

General Publications

• 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.
• Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 28, 2010
• First Submitted That Met QC Criteria: September 28, 2010
• First Posted (Estimate): September 29, 2010

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 7, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Sutures; Cosmesis; Staples; Wound infections; Aesthetic appearance of skin incision
• Other Study ID Numbers: 10D.199