NCT02028000

Brief Summary

The study is looking at women undergoing cesarean section delivery of their baby. The purpose of this research study is to determine what type of skin closure after cesarean section helps decrease pain level the most and improves the appearance of the incision site. The study hypothesis is to determine if skin closure with absorbable subcuticular staples leads to improved cosmesis and/or decreased post-operative pain. Participants in the study will already be scheduled for a cesarean section for delivery of their baby. They will be randomized into one of three groups, 1) Insorb (absorbable subcuticular stapes), 2) Vicryl suture or 3) Monocryl suture for the skin closure of their cesarean section. Information that will be recorded includes amount of pain medication usage while in the hospital after cesarean section, daily patient rated pain score until discharge from hospital, pain score 6 weeks after surgery and cesarean section cosmetic scar 6 weeks after surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2012

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

4 years

First QC Date

October 9, 2012

Last Update Submit

October 20, 2017

Conditions

Pregnancy

Keywords

PregnancyPregnantCesarean Section Delivery

Outcome Measures

Primary Outcomes (4)

  • Intravenous and analgesic use.

    Record the amount of in hospital intravenous and oral analgesic use.

    Admission for delivery of baby by cesarean section to expected postpartum average of 6 weeks

  • Daily subjective pain score while hospitalized

    Daily patient rated subjective pain score (0-10 based on visual analog scale) until dismissal from the hospital will be recorded.

    Hospital admission for cesarean section delivery

  • 6 week postoperative subjective pain score

    Patient rated subjective pain score 6 weeks postoperatively will be recorded.

    After cesarean section delivery at the 6 week postpartum visit

  • Scar cosmetic score 6 weeks post-operatively.

    6 weeks post-operative scar cosmetic score will be recorded.

    6 weeks post-operatively after cesarean section

Secondary Outcomes (2)

  • Wound complications

    Time of cesarean section until 6 weeks postpartum visit

  • Length of hospital stay

    C/S admission to discharge time

Study Arms (3)

INSORB staples skin closure

ACTIVE COMPARATOR

Women undergoing cesarean section delivery will have skin closure with INSORB staples.

Procedure: Monocryl skin closureProcedure: Vicryl skin closure

Monocryl skin closure

ACTIVE COMPARATOR

Women undergoing cesarean section delivery will have skin closure with Monocryl.

Procedure: Insorb staples skin closureProcedure: Vicryl skin closure

Vicryl skin closure

ACTIVE COMPARATOR

Women undergoing cesarean section delivery will have Vicryl skin closure

Procedure: Insorb staples skin closureProcedure: Monocryl skin closure

Interventions

Insorb staples skin closurePROCEDURE

Patients will be randomized to Insorb staples skin closure and compared to Monocryl and Vicryl group.

Monocryl skin closureVicryl skin closure
Monocryl skin closurePROCEDURE

Patients will be randomized to Monocryl skin closure and compared to Insorb skin closure and Vicryl skin closure.

INSORB staples skin closureVicryl skin closure
Vicryl skin closurePROCEDURE

Patients will be randomized to Vicryl skin closure and compared to Insorb and Monocryl skin closure groups.

INSORB staples skin closureMonocryl skin closure

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-44
  • Any race
  • Any parity
  • Scheduled Cesarean Section
  • Neuraxial analgesia

You may not qualify if:

  • Diabetes Mellitus
  • Maternal Connective Tissue Disorder
  • Maternal Steroid Use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Related Publications (11)

  • Walsh CA. Evidence-based cesarean technique. Curr Opin Obstet Gynecol. 2010 Apr;22(2):110-5. doi: 10.1097/GCO.0b013e3283372327.

    PMID: 20216417BACKGROUND

  • Johnson A, Young D, Reilly J. Caesarean section surgical site infection surveillance. J Hosp Infect. 2006 Sep;64(1):30-5. doi: 10.1016/j.jhin.2006.03.020. Epub 2006 Jul 5.

    PMID: 16822582BACKGROUND

  • Pineros-Fernandez A, Salopek LS, Rodeheaver PF, Drake DB, Edlich RF, Rodeheaver GT. A revolutionary advance in skin closure compared to current methods. J Long Term Eff Med Implants. 2006;16(1):19-27. doi: 10.1615/jlongtermeffmedimplants.v16.i1.30.

    PMID: 16566742BACKGROUND

  • Hamilton BE, Martin JA, Ventura SJ. Births: preliminary data for 2009. Natl Vital Stat Rep. 2010 Dec;59(3):1-19.

    PMID: 25073731BACKGROUND

  • Altman AD, Allen VM, McNeil SA, Dempster J. Pfannenstiel incision closure: a review of current skin closure techniques. J Obstet Gynaecol Can. 2009 Jun;31(6):514-520. doi: 10.1016/S1701-2163(16)34213-X.

    PMID: 19646316RESULT

  • Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. doi: 10.1016/j.ajog.2005.03.063.

    PMID: 16260200RESULT

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

    PMID: 9350017RESULT

  • Gaertner I, Burkhardt T, Beinder E. Scar appearance of different skin and subcutaneous tissue closure techniques in caesarean section: a randomized study. Eur J Obstet Gynecol Reprod Biol. 2008 May;138(1):29-33. doi: 10.1016/j.ejogrb.2007.07.003. Epub 2007 Sep 6.

    PMID: 17825472RESULT

  • 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.

    PMID: 19254586RESULT

  • Fick JL, Novo RE, Kirchhof N. Comparison of gross and histologic tissue responses of skin incisions closed by use of absorbable subcuticular staples, cutaneous metal staples, and polyglactin 910 suture in pigs. Am J Vet Res. 2005 Nov;66(11):1975-84. doi: 10.2460/ajvr.2005.66.1975.

    PMID: 16334959RESULT

  • Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10.

    PMID: 18090752RESULT

Study Officials

  • Joshua Nitsche, MD, PhD

    Wake Forest Baptist School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2012

First Posted

January 6, 2014

Study Start

January 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

October 24, 2017

Record last verified: 2017-10

Locations

US(1)