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Cesarean SectionCROSSNCT01211600

Cesarean Trial of Staples vs. Sutures

A study testing Staples and Suture in people with Cesarean Section and Wound Complications, run by Thomas Jefferson University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
What is being tested?
Staples and Suture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
746 participants
Where
2 sitesUnited States
Study dates
Jun 2010to Dec 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Women undergoing cesarean delivery for pregnancy greater than 23 weeks gestation.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Yale University

    New Haven, Connecticut

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Staples, Suture
Keywords
Staples, Sutures, Wound infections, Cosmesis, Aesthetic appearance of skin incision
Medical subject headings
Patient Satisfaction, Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StaplesOther

    Also called Closure Technique

    Interrupted Ethicon Staples

  • SutureOther

    Also called Closure Technique

    Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)

Study groups in NCT01211600
Study groupRoleWhat they receive
StaplesActive comparatorInterrupted Ethicon Staples
Receives: Other: Staples
SutureActive comparatorSubcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
Receives: Other: Suture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 6 weeks of postpartum

Secondary outcomes (12)

  1. 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.

    Measured: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.

  2. 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.

    Measured: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.

  3. 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.

    Measured: Immediately postpartum to time of discharge, which is typically 3-4 days post-cesarean

  4. 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).

    Measured: Within 6 weeks postpartum

  5. Number of Participants With Primary Versus Repeat Cesarean

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

    Measured: At randomization.

  6. 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

    Measured: Time of Cesarean

  7. Intraoperative Trial Details - Closure of Subcutaneous Tissue

    Number of participants requiring subcutaneous tissue closure

    Measured: Time of Cesarean

  8. Length of Hospital Stay

    Length of hospital stay (days)

    Measured: Immediate postpartum.

  9. Number of Participants That Received Anticoagulation Within 24 Hours

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

    Measured: Within 24 hours postpartum.

  10. Number of Participants Diagnosed With Endomyometritis

    Number of participants diagnosed with endomyometritis requiring antibiotics

    Measured: Immediate postpartum.

  11. Change in Hemoglobin Pre-operatively to Post-operatively

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

    Measured: Up to 72 hours before and 24 hours after cesarean.

  12. 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.

    Measured: Immediately postpartum and 4 - 8 weeks after intervention, up to 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionOct 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
746 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01211600
Sponsor's protocol ID
10D.199
Acronym
CROSS
Status last verified
Nov 2019
First submitted
28 Sep 2010
Last updated
26 Nov 2019
Data monitoring committee
No

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.

    PubMed 19254586

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

    PubMed 9350017

  • 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.

    PubMed 12804476

  • 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.

    PubMed 20816153

  • 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.

    PubMed 26348166

  • 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.

    PubMed 24807325

Questions about this trial

What is this clinical trial studying?

A study testing Staples and Suture in people with Cesarean Section and Wound Complications, run by Thomas Jefferson University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Wound Complications (time frame: Within 6 weeks of postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01211600, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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