Alexis O-Ring Wound Retractor for the Prevention of Post-cesarean Surgical Site Infections

NCT03365219 | Completed DMC

• 1 other identifier: 10-188
• Study Type: interventional
• Target: 564
• Locations: 0 countries
• Sites: N/A

Brief Summary

Post cesarean section surgical site infection (SSI) is a common complication that can affect patient recovery and overall outcome. Several approaches have been studied to improve SSI rates such as timing of antibiotic administration and skin preparation. Alexis retractors have been suggested as a reasonable option to decrease SSI. However, to date there is only one randomized controlled study assessing its efficacy. The aim of this study is to whether Alexis wound retractors are beneficial in preventing cesarean section SSI.

Conditions

Surgical Wound Infection

Keywords

Surgical Site Infection; Cesarean delivery infection

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection

  Assessed as present or absent. Defined as the development of wound infection, seroma, or other wound disruption in patients who underwent a cesarean delivery

  Time of surgery up to 14 post operative days

Secondary Outcomes (4)

• Postoperative pain

  Time of surgery up to 14 post operative days

• Estimated blood loss

  intraoperative assessment

• Uterus exteriorization

  intraoperative assessment

• Total operative time

  intraoperative assessment

Other Outcomes (5)

• Apgar scores

  Assessed in every infant at 1 minute and 5 minutes of life

• Gestational age at time of delivery

  at time of delivery

• Infant weight

  At time of delivery

Study Arms (2)

Alexis Retractor

EXPERIMENTAL

This group received an Alexis O-Ring Wound Retractor during cesarean delivery.

Device: Alexis O-Ring Wound Retractor

Standard Surgical Retractors

ACTIVE COMPARATOR

This group received routine hand-held metal retractors as needed by the surgical team during cesarean delivery.

Other: Standard Surgical Retractors

Interventions

Alexis O-Ring Wound Retractor DEVICE

A flexible self-retaining plastic Alexis retractor was used in place of standard surgical retractors.

Alexis Retractor

Standard Surgical Retractors OTHER

Routine hand-held metal retractors as needed by the surgical team

Standard Surgical Retractors

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• maternal age of at least 18 years
• a gestational age of at least 24 0/7 wks by best obstetric estimate
• a viable gestation
• a non-emergent cesarean delivery
• a planned transverse skin incision
• Deliveries included: primary cesarean for failed induction, maternal request, or other obstetric indications; and repeat cesarean deliveries that were elective or had obstetric indications (such as spontaneous labor in a subject with a term gestation and with history of 2 or more prior cesarean deliveries)

You may not qualify if:

• chorioamnionitis
• chronic corticosteroid therapy
• prior abdominal vertical skin incision scar or planned vertical incision
• history of a prior wound infection or separation
• planned cesarean hysterectomy
• maternal or fetal complications requiring an emergent delivery

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Related Publications (12)

• Menacker F, Hamilton BE. Recent trends in cesarean delivery in the United States. NCHS Data Brief. 2010 Mar;(35):1-8.

  PMID: 20334736 BACKGROUND

• Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999 Nov;20(11):725-30. doi: 10.1086/501572.

  PMID: 10580621 BACKGROUND

• Stone PW, Braccia D, Larson E. Systematic review of economic analyses of health care-associated infections. Am J Infect Control. 2005 Nov;33(9):501-9. doi: 10.1016/j.ajic.2005.04.246.

  PMID: 16260325 BACKGROUND

• Moir-Bussy B, Hutton R, Thompson J. Wound infection after caesarean section. Nurs Times. 1985 Jun 5-11;81(23):suppl 13-4. No abstract available.

  PMID: 3847906 BACKGROUND

• Rauk PN. Educational intervention, revised instrument sterilization methods, and comprehensive preoperative skin preparation protocol reduce cesarean section surgical site infections. Am J Infect Control. 2010 May;38(4):319-23. doi: 10.1016/j.ajic.2009.10.004. Epub 2010 Feb 19.

  PMID: 20171756 BACKGROUND

• Schneid-Kofman N, Sheiner E, Levy A, Holcberg G. Risk factors for wound infection following cesarean deliveries. Int J Gynaecol Obstet. 2005 Jul;90(1):10-5. doi: 10.1016/j.ijgo.2005.03.020.

  PMID: 15913620 BACKGROUND

• Tran TS, Jamulitrat S, Chongsuvivatwong V, Geater A. Risk factors for postcesarean surgical site infection. Obstet Gynecol. 2000 Mar;95(3):367-71. doi: 10.1016/s0029-7844(99)00540-2.

  PMID: 10711546 BACKGROUND

• Weiss JL, Malone FD, Emig D, Ball RH, Nyberg DA, Comstock CH, Saade G, Eddleman K, Carter SM, Craigo SD, Carr SR, D'Alton ME; FASTER Research Consortium. Obesity, obstetric complications and cesarean delivery rate--a population-based screening study. Am J Obstet Gynecol. 2004 Apr;190(4):1091-7. doi: 10.1016/j.ajog.2003.09.058.

  PMID: 15118648 BACKGROUND

• Cedergren MI. Maternal morbid obesity and the risk of adverse pregnancy outcome. Obstet Gynecol. 2004 Feb;103(2):219-24. doi: 10.1097/01.AOG.0000107291.46159.00.

  PMID: 14754687 BACKGROUND

• ACOG Practice Bulletin No. 120: Use of prophylactic antibiotics in labor and delivery. Obstet Gynecol. 2011 Jun;117(6):1472-1483. doi: 10.1097/AOG.0b013e3182238c31. No abstract available.

  PMID: 21606770 BACKGROUND

• Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96.

  PMID: 10196487 BACKGROUND

• Cheng KP, Roslani AC, Sehha N, Kueh JH, Law CW, Chong HY, Arumugam K. ALEXIS O-Ring wound retractor vs conventional wound protection for the prevention of surgical site infections in colorectal resections(1). Colorectal Dis. 2012 Jun;14(6):e346-51. doi: 10.1111/j.1463-1318.2012.02943.x.

  PMID: 22568647 RESULT

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gayle L Olson, MD

  University of Texas Medical Branch in Galveston

  PRINCIPAL INVESTIGATOR

• George Saade, MD

  University of Texas Medical Branch in Galveston

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: December 7, 2017
• Study Start: October 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 19, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share