Cesarean Trial of Staples vs. Sutures

Cesarean Section Clinical Trial

— CROSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211600
• Other study ID #: 10D.199
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: December 2014

Study information

• Verified date: November 2019
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 746
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Pain Measurement
• Patient Satisfaction
• Wound Complications

Intervention

Other:
• Staples
Interrupted Ethicon Staples
• Suture
Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Main Line Health

Country where clinical trial is conducted

United States, 

References & Publications (4)

Alderdice F, McKenna D, Dornan J. Techniques and materials for skin closure in caesarean section. Cochrane Database Syst Rev. 2003;(2):CD003577. Review. Update in: Cochrane Database Syst Rev. 2012;9:CD003577. — View Citation

Basha SL, Rochon ML, Quiñones 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	Number of Participants With Primary Versus Repeat Cesarean	Randomization stratum - BMI (over/under 30) and Cesarean (primary or repeat)	At randomization.
Secondary	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
Secondary	Intraoperative Trial Details - Closure of Subcutaneous Tissue	Number of participants requiring subcutaneous tissue closure	Time of Cesarean
Secondary	Length of Hospital Stay	Length of hospital stay (days)	Immediate postpartum.
Secondary	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.
Secondary	Number of Participants Diagnosed With Endomyometritis	Number of participants diagnosed with endomyometritis requiring antibiotics	Immediate postpartum.
Secondary	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.
Secondary	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.