CROSS: Cesarean Trial of Staples vs. Sutures

• Sponsor: Thomas Jefferson University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01211600
• Collaborator: Main Line Health (Other)
• Enrollment: 746
• Locations: 2
• Arms: 2
• Duration (Months): 54
• Patients Per Site: 373
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section; Wound Complications; Patient Satisfaction; Pain Measurement	Other: Staples; Other: Suture	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 746 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Cesarean Randomized Control Trial Of Sutures vs. Staples (CROSS)
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Wound Complications [Within 6 weeks of postpartum]

   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.

Secondary Outcome Measures

1. Patient Scar Assessment Scale Scores for Evaluation of Cosmesis [Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.]

   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.

2. Patient Satisfaction With Closure Method and Scar Appearance [Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.]

   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.

3. Pain Perception [Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean]

   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.

4. Additional Provider Visits [Within 6 weeks postpartum]

   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).

5. Number of Participants With Primary Versus Repeat Cesarean [At randomization.]

   Randomization stratum - BMI (over/under 30) and Cesarean (primary or repeat)

6. Intraoperative Trial Details - Duration of Operation and Skin Closure [Time of Cesarean]

   Duration of operation: skin incision to skin closure Duration of skin closure: fascial closure to skin closure

7. Intraoperative Trial Details - Closure of Subcutaneous Tissue [Time of Cesarean]

   Number of participants requiring subcutaneous tissue closure

8. Length of Hospital Stay [Immediate postpartum.]

   Length of hospital stay (days)

9. Number of Participants That Received Anticoagulation Within 24 Hours [Within 24 hours postpartum.]

   Number of participants that received anticoagulation within 24 hours of procedure (preoperatively or postoperatively)

10. Number of Participants Diagnosed With Endomyometritis [Immediate postpartum.]

    Number of participants diagnosed with endomyometritis requiring antibiotics

11. Change in Hemoglobin Pre-operatively to Post-operatively [Up to 72 hours before and 24 hours after cesarean.]

    Median change in hemoglobin from preoperative value (g/dL) to post-operatively.

12. Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures. [Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States
2	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Thomas Jefferson University
• Main Line Health

Investigators

• Principal Investigator: A. Dhanya Mackeen, MD, MPH, Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT01211600
• Other Study ID Numbers: 10D.199
• First Posted: Sep 29, 2010
• Last Update Posted: Nov 26, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by Thomas Jefferson University: Staples; Sutures; Wound infections; Cosmesis; Aesthetic appearance of skin incision

Study Results

Participant Flow

Arm/Group Title	Suture	Staples
Arm/Group Description	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)	Interrupted Ethicon Staples
Period Title: Overall Study
STARTED	370	376
COMPLETED	370	376
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Suture	Staples	Total
Arm/Group Description	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)	Interrupted Ethicon Staples	Total of all reporting groups
Overall Participants	370	376	746
Age (years) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [years]	31.0	31.0	31.0
Sex: Female, Male (Count of Participants)
Female	370 100%	376 100%	746 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
African American	158 42.7%	167 44.4%	325 43.6%
Caucasian	162 43.8%	154 41%	316 42.4%
Hispanic	19 5.1%	24 6.4%	43 5.8%
Asian	16 4.3%	22 5.9%	38 5.1%
Other	15 4.1%	8 2.1%	23 3.1%
Unknown	0 0%	1 0.3%	1 0.1%
Pregnancy History - Singleton Gestation (Count of Participants)
Count of Participants [Participants]	353 95.4%	351 93.4%	704 94.4%
Number of Previous Cesareans (Count of Participants)
0 Previous Cesareans	180 48.6%	177 47.1%	357 47.9%
1 Previous Cesarean	120 32.4%	132 35.1%	252 33.8%
More than 1 Previous Cesarean	70 18.9%	67 17.8%	137 18.4%
Term Gestation (Count of Participants)
Count of Participants [Participants]	317 85.7%	329 87.5%	646 86.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Wound Complications
Description	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.
Time Frame	Within 6 weeks of postpartum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Suture	Staples
Arm/Group Description	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)	Interrupted Ethicon Staples
Measure Participants	370	376
Total patients with at least 1 wound complicatin	18 4.9%	40 10.6%
Infection	9 2.4%	14 3.7%
Hematoma	2 0.5%	4 1.1%
Seroma	5 1.4%	6 1.6%
Separation	6 1.6%	28 7.4%
Readmission for wound complication	2 0.5%	3 0.8%

2. Secondary Outcome

Title	Patient Scar Assessment Scale Scores for Evaluation of Cosmesis
Description	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.
Time Frame	Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Suture	Staples
Arm/Group Description	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)	Interrupted Ethicon Staples
Measure Participants	286	291
Median (Inter-Quartile Range) [score on a scale]	15	20

3. Secondary Outcome

Title	Patient Satisfaction With Closure Method and Scar Appearance
Description	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.
Time Frame	Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.

Outcome Measure Data

Analysis Population Description

Patient satisfaction data were available for 606 participants. Two participants in the Staples arm did not provide scores for scar appearance satisfaction. This is why we are representing 305 of the 307 subjects' responses to satisfaction of scar appearance.

Arm/Group Title	Staples	Suture
Arm/Group Description	Interrupted Ethicon Staples Staples: Interrupted Ethicon Staples	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle) Suture: Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
Measure Participants	307	299
Satisfaction with Closure Method	9	10
Satisfaction with Scar Appearance	9	9

4. Secondary Outcome

Title	Pain Perception
Description	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.
Time Frame	Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Suture	Staples
Arm/Group Description	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)	Interrupted Ethicon Staples
Measure Participants	370	376
Less than 24 hours	3.5	3.6
24 - 47 hours	4.3	4.3
48 - 72 hours	4.3	4.2
Pain at time of Discharge	3.5	3.6

5. Secondary Outcome

Title	Additional Provider Visits
Description	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).
Time Frame	Within 6 weeks postpartum

Outcome Measure Data

Analysis Population Description

The number analyzed in the "Number of visits - diagnosed wound complication" and "Number of visits - no diagnosed wound complication" rows indicates the breakdown of subjects within each arm that did and did not have a diagnosed wound complication.

Arm/Group Title	Suture	Staples
Arm/Group Description	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)	Interrupted Ethicon Staples
Measure Participants	370	376
All wound visits	.9	1.5
Number of visits - diagnosed wound complication	2.7	2.9
Number of visits - no diagnosed wound complication	.8	1.4

6. Secondary Outcome

Title	Number of Participants With Primary Versus Repeat Cesarean
Description	Randomization stratum - BMI (over/under 30) and Cesarean (primary or repeat)
Time Frame	At randomization.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Suture	Staples
Arm/Group Description	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)	Interrupted Ethicon Staples
Measure Participants	370	376
BMI 30 or greater - primary cesarean delivery	109 29.5%	106 28.2%
BMI 30 or greater - repeat cesarean delivery	126 34.1%	132 35.1%
BMI less than 30 - primary cesarean delivery	71 19.2%	71 18.9%
BMI less than 30 - repeat cesarean delivery	64 17.3%	67 17.8%

7. Secondary Outcome

Title	Intraoperative Trial Details - Duration of Operation and Skin Closure
Description	Duration of operation: skin incision to skin closure Duration of skin closure: fascial closure to skin closure
Time Frame	Time of Cesarean

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Suture	Staples
Arm/Group Description	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)	Interrupted Ethicon Staples
Measure Participants	370	376
Duration of Operation	58.5	51
Duration of Skin Closure	15	6

8. Secondary Outcome

Title	Intraoperative Trial Details - Closure of Subcutaneous Tissue
Description	Number of participants requiring subcutaneous tissue closure
Time Frame	Time of Cesarean

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Suture	Staples
Arm/Group Description	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)	Interrupted Ethicon Staples
Measure Participants	370	376
Count of Participants [Participants]	201 54.3%	202 53.7%

9. Secondary Outcome

Title	Length of Hospital Stay
Description	Length of hospital stay (days)
Time Frame	Immediate postpartum.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Suture	Staples
Arm/Group Description	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)	Interrupted Ethicon Staples
Measure Participants	370	376
Median (Inter-Quartile Range) [Days]	4.4	4.5

10. Secondary Outcome

Title	Number of Participants That Received Anticoagulation Within 24 Hours
Description	Number of participants that received anticoagulation within 24 hours of procedure (preoperatively or postoperatively)
Time Frame	Within 24 hours postpartum.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Suture	Staples
Arm/Group Description	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)	Interrupted Ethicon Staples
Measure Participants	370	376
Count of Participants [Participants]	14 3.8%	17 4.5%

11. Secondary Outcome

Title	Number of Participants Diagnosed With Endomyometritis
Description	Number of participants diagnosed with endomyometritis requiring antibiotics
Time Frame	Immediate postpartum.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Suture	Staples
Arm/Group Description	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)	Interrupted Ethicon Staples
Measure Participants	370	376
Count of Participants [Participants]	11 3%	7 1.9%

12. Secondary Outcome

Title	Change in Hemoglobin Pre-operatively to Post-operatively
Description	Median change in hemoglobin from preoperative value (g/dL) to post-operatively.
Time Frame	Up to 72 hours before and 24 hours after cesarean.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Suture	Staples
Arm/Group Description	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)	Interrupted Ethicon Staples
Measure Participants	370	376
Median (Inter-Quartile Range) [g/dL]	-1.8	-1.8

13. Secondary Outcome

Title	Observer Evaluation of Cosmesis of the Cesarean Incision Based on Closure Method: Staples vs Sutures.
Description	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.
Time Frame	Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Suture	Staples
Arm/Group Description	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)	Interrupted Ethicon Staples
Measure Participants	137	138
Median (Inter-Quartile Range) [score on a scale]	12	13

Adverse Events

Time Frame	Adverse events were monitored from the time of randomization to 30 days postpartum.
Arm/Group Title	Suture		Staples
Arm/Group Description	Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)		Interrupted Ethicon Staples
All Cause Mortality
	Suture		Staples
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/370 (0%)		0/376 (0%)
Serious Adverse Events
	Suture		Staples
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/370 (0%)		0/376 (0%)
Other (Not Including Serious) Adverse Events
	Suture		Staples
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/370 (4.9%)		40/376 (10.6%)
Skin and subcutaneous tissue disorders
Wound Complications	18/370 (4.9%)	18	40/376 (10.6%)	40

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.