NCT02459093

Brief Summary

A comparison of the type of suture used for cesarean skin incision approximation and the subsequent rate of wound complications has not been widely studied. Investigators seek to compare poliglecaprone 25 and polyglactin 910 suture used in a subcuticular skin closure in Pfannenstiel incisions during cesarean birth and determine the subsequent wound complication rates (SSI, hematoma, seroma, wound separation).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

June 1, 2018

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

May 28, 2015

Results QC Date

May 1, 2018

Last Update Submit

May 1, 2018

Conditions

Complications; Cesarean SectionSurgical Wound Infection

Keywords

wound complications

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)

    Any wound disruption, fluid accumulation, separation, all CDC defined stages of surgical site infection (SSI)

    30 days

Study Arms (2)

poliglecaprone 25 suture

EXPERIMENTAL

Subcuticular skin approximation with poliglecaprone 25 suture at cesarean birth surgery

Device: poliglecaprone 25 suture

polyglactin 910 suture

EXPERIMENTAL

Subcuticular skin approximation with polyglactin 910 suture at cesarean birth surgery

Device: polyglactin 910 suture

Interventions

poliglecaprone 25 sutureDEVICE

cesarean delivery incision closure with poliglecaprone 25 suture

Also known as: MONOCRYL Suture (poliglecaprone 25 suture)
poliglecaprone 25 suture
polyglactin 910 sutureDEVICE

cesarean delivery incision closure with polyglactin 910 suture

Also known as: VICRYL Suture (polyglactin 910 suture)
polyglactin 910 suture

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Gestational age of 37 completed weeks or greater based on their estimated due date calculated from last menstrual period or early ultrasound.
  • Patients participating will be undergoing either:
  • Scheduled cesarean delivery
  • Non-emergent cesarean delivery

You may not qualify if:

  • Urogenital tract infection within 2 weeks prior to surgery
  • Chronic oral or injectable steroid use (\> 2 weeks)
  • Emergency cesarean delivery (need to deliver immediately due to a maternal or fetal indication)
  • Vertical skin incision
  • Active participation in another research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Montefiore Medical Center Weiler Division

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center Wakefield Division

The Bronx, New York, 10466, United States

Location

Related Publications (8)

  • Vats U, Pandit Suchitra N. Comparison of Efficacy of Three Suture Materials, i.e., Poliglecaprone 25, Polyglactin 910, Polyamide, as Subcuticular Skin Stitches in Post-Cesarean Women: A Randomized Clinical Trial. J Obstet Gynaecol India. 2014 Feb;64(1):14-8. doi: 10.1007/s13224-013-0448-5. Epub 2013 Sep 4.

    PMID: 24587600BACKGROUND

  • Nuthalapaty FS, Lee CM, Lee JH, Kuper SG, Higdon HL 3rd. A randomized controlled trial of early versus delayed skin staple removal following caesarean section in the obese patient. J Obstet Gynaecol Can. 2013 May;35(5):426-433. doi: 10.1016/S1701-2163(15)30933-6.

    PMID: 23756273BACKGROUND

  • Mourad M, Silverstein M, Bender S, Melka S, Klauser CK, Gupta S, Saltzman DH, Rebarber A, Fox NS. The effect of maternal obesity on outcomes in patients undergoing tertiary or higher cesarean delivery. J Matern Fetal Neonatal Med. 2015 Jun;28(9):989-93. doi: 10.3109/14767058.2014.941284. Epub 2014 Jul 24.

    PMID: 25058127BACKGROUND

  • Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control. 2008 Jun;36(5):309-32. doi: 10.1016/j.ajic.2008.03.002. No abstract available.

    PMID: 18538699BACKGROUND

  • 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.

    PMID: 24807325BACKGROUND

  • Corbacioglu Esmer A, Goksedef PC, Akca A, Akbayir O, Dagdeviren H, Turan GY, Yarsilikal F. Role of subcutaneous closure in preventing wound complications after cesarean delivery with Pfannenstiel incision: a randomized clinical trial. J Obstet Gynaecol Res. 2014 Mar;40(3):728-35. doi: 10.1111/jog.12229.

    PMID: 24738117BACKGROUND

  • Martin JA, Hamilton BE, Osterman MJ, Curtin SC, Matthews TJ. Births: final data for 2012. Natl Vital Stat Rep. 2013 Dec 30;62(9):1-68.

    PMID: 25671704BACKGROUND

  • Buresch AM, Van Arsdale A, Ferzli M, Sahasrabudhe N, Sun M, Bernstein J, Bernstein PS, Ngai IM, Garry DJ. Comparison of Subcuticular Suture Type for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Sep;130(3):521-526. doi: 10.1097/AOG.0000000000002200.

    PMID: 28796687RESULT

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr David Garry
Organization
Stony Brook Medicine
david.garry@stonybrookmedicine.edu
631-444-7650

Study Officials

  • David Garry, DO

    Montefiore Medical Center / Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Maternal Fetal Medicine Specialist

Study Record Dates

First Submitted

May 28, 2015

First Posted

June 1, 2015

Study Start

May 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

June 1, 2018

Results First Posted

June 1, 2018

Record last verified: 2018-05

Locations

US(2)