NCT03136159

Brief Summary

Post-cesarean section wound infections are responsible for longer hospital stays, readmissions, and ultimately, increased costs to the healthcare system. Silver-containing dressings may prevent wound infections. The purpose of the current study is to determine if the use of a silver-impregnated dressing decreases the occurence of wound infection following cesarean delivery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 2, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

July 24, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 21, 2020

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

1.9 years

First QC Date

April 27, 2017

Results QC Date

September 24, 2020

Last Update Submit

December 18, 2020

Conditions

Cesarean Section; Complications, Wound, Dehiscence

Keywords

pregnancydeliverycesarean sectionwound healingsilver-containing dressing

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Wound Disruption and/or Infection

    Rate of wound disruption and /or infection occurring by 6 weeks was compared to a historical control rate of 10%, and to a contemporary group who received a standard dressing

    6 weeks postoperative

Study Arms (1)

Silver-impregnated antimicrobial dressing

EXPERIMENTAL

All participants undergoing primary cesarean section will receive a silver impregnated antimicrobial wound dressing (Mepilex Border AG), postoperative.

Device: Silver-impregnated antimicrobial dressing

Interventions

Silver-impregnated antimicrobial dressingDEVICE

All participants will receive an adherent soft silicone silver impregnated anti-microbial occlusive foam dressing after cesarean section. The dressing will stay on for up to seven days.

Also known as: Mepilex Border AG
Silver-impregnated antimicrobial dressing

Eligibility Criteria

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

You may qualify if:

  • Consent to undergo cesarean delivery
  • Between the ages of 18 and 45
  • Primary C-section
  • Subcuticular skin closure
  • Able to consent, fill out study documents, and complete all study procedures and follow-up visits

You may not qualify if:

  • Patients with an allergy to silver
  • Inability to obtain informed consent
  • Staples
  • Repeat C-section
  • Vertical skin incision
  • Intrapartum fever of 100F or \>

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (22)

  • Gibbs RS. Clinical risk factors for puerperal infection. Obstet Gynecol. 1980 May;55(5 Suppl):178S-184S. doi: 10.1097/00006250-198003001-00045.

    PMID: 6990333BACKGROUND

  • Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Mathews TJ. Births: final data for 2011. Natl Vital Stat Rep. 2013 Jun 28;62(1):1-69, 72.

    PMID: 24974591BACKGROUND

  • Owen J, Andrews WW. Wound complications after cesarean sections. Clin Obstet Gynecol. 1994 Dec;37(4):842-55. doi: 10.1097/00003081-199412000-00009. No abstract available.

    PMID: 7842552BACKGROUND

  • National Nosocomial Infections Surveillance System. National Nosocomial Infections Surveillance (NNIS) System Report, data summary from January 1992 through June 2004, issued October 2004. Am J Infect Control. 2004 Dec;32(8):470-85. doi: 10.1016/S0196655304005425. No abstract available.

    PMID: 15573054BACKGROUND

  • Opoien HK, Valbo A, Grinde-Andersen A, Walberg M. Post-cesarean surgical site infections according to CDC standards: rates and risk factors. A prospective cohort study. Acta Obstet Gynecol Scand. 2007;86(9):1097-102. doi: 10.1080/00016340701515225.

    PMID: 17712651BACKGROUND

  • Vermillion ST, Lamoutte C, Soper DE, Verdeja A. Wound infection after cesarean: effect of subcutaneous tissue thickness. Obstet Gynecol. 2000 Jun;95(6 Pt 1):923-6. doi: 10.1016/s0029-7844(99)00642-0.

    PMID: 10831993BACKGROUND

  • Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG, Banerjee SN, Edwards JR, Tolson JS, Henderson TS, et al. Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):152S-157S. doi: 10.1016/0002-9343(91)90361-z.

    PMID: 1656747BACKGROUND

  • Yokoe DS, Christiansen CL, Johnson R, Sands KE, Livingston J, Shtatland ES, Platt R. Epidemiology of and surveillance for postpartum infections. Emerg Infect Dis. 2001 Sep-Oct;7(5):837-41. doi: 10.3201/eid0705.010511.

    PMID: 11747696BACKGROUND

  • Declercq E, Barger M, Cabral HJ, Evans SR, Kotelchuck M, Simon C, Weiss J, Heffner LJ. Maternal outcomes associated with planned primary cesarean births compared with planned vaginal births. Obstet Gynecol. 2007 Mar;109(3):669-77. doi: 10.1097/01.AOG.0000255668.20639.40.

    PMID: 17329519BACKGROUND

  • Cardoso Del Monte MC, Pinto Neto AM. Postdischarge surveillance following cesarean section: the incidence of surgical site infection and associated factors. Am J Infect Control. 2010 Aug;38(6):467-72. doi: 10.1016/j.ajic.2009.10.008. Epub 2010 Mar 12.

    PMID: 20226571BACKGROUND

  • Zimlichman E, Henderson D, Tamir O, Franz C, Song P, Yamin CK, Keohane C, Denham CR, Bates DW. Health care-associated infections: a meta-analysis of costs and financial impact on the US health care system. JAMA Intern Med. 2013 Dec 9-23;173(22):2039-46. doi: 10.1001/jamainternmed.2013.9763.

    PMID: 23999949BACKGROUND

  • Olsen MA, Butler AM, Willers DM, Gross GA, Hamilton BH, Fraser VJ. Attributable costs of surgical site infection and endometritis after low transverse cesarean delivery. Infect Control Hosp Epidemiol. 2010 Mar;31(3):276-82. doi: 10.1086/650755.

    PMID: 20102279BACKGROUND

  • Smaill FM, Grivell RM. Antibiotic prophylaxis versus no prophylaxis for preventing infection after cesarean section. Cochrane Database Syst Rev. 2014 Oct 28;2014(10):CD007482. doi: 10.1002/14651858.CD007482.pub3.

    PMID: 25350672BACKGROUND

  • Haas DM, Morgan S, Contreras K. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD007892. doi: 10.1002/14651858.CD007892.pub3.

    PMID: 23440819BACKGROUND

  • Silvestry-Rodriguez N, Sicairos-Ruelas EE, Gerba CP, Bright KR. Silver as a disinfectant. Rev Environ Contam Toxicol. 2007;191:23-45. doi: 10.1007/978-0-387-69163-3_2.

    PMID: 17708071BACKGROUND

  • Krieger BR, Davis DM, Sanchez JE, Mateka JJ, Nfonsam VN, Frattini JC, Marcet JE. The use of silver nylon in preventing surgical site infections following colon and rectal surgery. Dis Colon Rectum. 2011 Aug;54(8):1014-9. doi: 10.1097/DCR.0b013e31821c495d.

    PMID: 21730792BACKGROUND

  • Biffi R, Fattori L, Bertani E, Radice D, Rotmensz N, Misitano P, Cenciarelli S, Chiappa A, Tadini L, Mancini M, Pesenti G, Andreoni B, Nespoli A. Surgical site infections following colorectal cancer surgery: a randomized prospective trial comparing common and advanced antimicrobial dressing containing ionic silver. World J Surg Oncol. 2012 May 23;10:94. doi: 10.1186/1477-7819-10-94.

    PMID: 22621779BACKGROUND

  • Epstein NE. Do silver-impregnated dressings limit infections after lumbar laminectomy with instrumented fusion? Surg Neurol. 2007 Nov;68(5):483-5; discussion 485. doi: 10.1016/j.surneu.2007.05.045.

    PMID: 17961738BACKGROUND

  • Siah CJ, Yatim J. Efficacy of a total occlusive ionic silver-containing dressing combination in decreasing risk of surgical site infection: an RCT. J Wound Care. 2011 Dec;20(12):561-8. doi: 10.12968/jowc.2011.20.12.561.

    PMID: 22240882BACKGROUND

  • Connery SA, Downes KL, Young C. A retrospective study evaluating silver-impregnated dressings on cesarean wound healing. Adv Skin Wound Care. 2012 Sep;25(9):414-9. doi: 10.1097/01.ASW.0000419407.37323.e8.

    PMID: 22914038BACKGROUND

  • Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.

    PMID: 10219875BACKGROUND

  • 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: 18090752BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

Title
Dr Jean Goodman
Organization
Loyola University Medical Center
Jrgoodman@lumc.edu
7082165459

Study Officials

  • Jean Goodman, MD

    Loyola University Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Maternal Fetal Medicine

Study Record Dates

First Submitted

April 27, 2017

First Posted

May 2, 2017

Study Start

July 24, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

December 21, 2020

Results First Posted

December 21, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)