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The Role of Antimicrobial Foam Dressing in Prevention of Cesarean Section Wound Complications

NCT ID: NCT03136159

Last Updated: 2020-12-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-24

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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A single-centered, single-arm clinical trial was originally designed to investigate the effects of an adherent soft silicone anti-microbial occlusive foam silver-impregnated dressing in preventing surgical site infection (SSI) in women delivered by primary cesarean section (CS). We sought to determine if the incidence of SSIs, would be lower in patients who received a silver-impregnated dressing as compared to those who received a standard dressing, when used as part of the overall hospital protocol for reducing SSIs. Given the addition of adjunctive azithromycin antibiotic prophylaxis for those who labored or had rupture of membranes prior to undergoing a non-elective CS right at the time of initiation of the study to our institution perioperative bundle, we also elected to undertake further analyses of observational data on those with the same study inclusion criteria receiving standard dressing undergoing primary CS with subcuticular skin closure during the same time period, rather than limiting comparisons of our outcomes solely to our historical SSI rates. In order to have this comparison group, patients who declined participation in the experimental groups were selected as our non-randomized control group, given fiscal restraints precluded conducting a randomized clinical trial (RCT). Demographic, labor, delivery, intraoperative and postoperative characteristic data were collected in a de-identified fashion. Medical record review and data entry were conducted by trained research personnel. All study procedures were approved by the Investigational Review Board.

Conditions

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Cesarean Section; Complications, Wound, Dehiscence

Keywords

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pregnancy delivery cesarean section wound healing silver-containing dressing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Silver-impregnated antimicrobial dressing

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

Group Type EXPERIMENTAL

Silver-impregnated antimicrobial dressing

Intervention Type DEVICE

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.

Interventions

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Silver-impregnated antimicrobial dressing

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.

Intervention Type DEVICE

Other Intervention Names

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Mepilex Border AG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Molnlycke Health Care AB

INDUSTRY

Sponsor Role collaborator

Loyola University

OTHER

Sponsor Role lead

Responsible Party

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Jean Goodman

Director of Maternal Fetal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean Goodman, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola University Chicago

Locations

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Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND
PMID: 6990333 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24974591 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7842552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15573054 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17712651 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10831993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1656747 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11747696 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17329519 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20226571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23999949 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20102279 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25350672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23440819 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17708071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21730792 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22621779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17961738 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22240882 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22914038 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10219875 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18090752 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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207526

Identifier Type: -

Identifier Source: org_study_id