Prospective Study on Cesarean Wound Outcomes

Surgical Site Infection Clinical Trial

Official title:

A Prospective Randomized Study Assessing Post Operative Wound Infections Along With Cosmetic Outcomes Using Silver Plated Dressings Compared to Conventional Dressings on Cesarean Section Incisions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01927211
• Other study ID #: USF Csection Study
• Status: Recruiting
• Phase: N/A
• First received: August 20, 2013
• Last updated: December 28, 2015
• Start date: July 2013

Study information

• Verified date: December 2015
• Source: Argentum Medical LLC
• Contact: Melissa Cardenas, BS
• Phone: 813-259-8680
• Email: obgynclinicalresearch[@]health.usf.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study will investigate whether the placement of silver plated dressings beginning in the OR will improve wound healing in patients undergoing cesarean delivery compared to traditional Telfa pads. This study will also explore the presumed improvement in scar integrity when silver plated dressings are used compared to Telfa pads. The study will examine post-operative pain by review of anesthesia and analgesic use during hospitalization and scar-related pain scores at the post-operative visits.

The study will compare the percentage of patients who develop a surgical site infection after application of silver plated dressings versus standard Telfa dressings. Investigators will also assess the cosmetic appearance of the cesarean section scar at the patient's one week and 6 wekk post-operative visits.

Description:

This is a randomized, prospective study involving 660 patients undergoing cesarean sections at Tampa General Hospital. The control group (n=330) will receive standard Telfa pad dressing and the treatment group (n=330) will receive the silver plated dressing.

The primary objective is to compare the percentage of patients who develop a surgical site infection between the two groups at 1-week and 6-weeks post operative visits. The secondary objective is to assess the cosmetic outcome of the cesarean incision observed at the 1-week and 6-week post-operative visits. A panel of plastic surgeons will conduct a blinded assessment of cosmetic outcome by review of photographs taken of the wounds at 1-week and 6-weeks. Finally, this study will examine post-operative pain by review of anesthesia and analgesic use during hospitalization and scar-related pain scores at the post-operative visits.

Other known NCT identifiers

• NCT01697748

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Elective and emergent cesarean deliveries

• Primary and repeat cesarean section

• Transverse skin incisions (Pfannenstiel)

• Low transverse uterine incision

• Patients with or without the diagnosis of chorioamnionitis with antibiotic treatment prior to or after the delivery of the baby

• Single and multiple gestations

• Willing and able to provide written informed consent

Exclusion Criteria:

• Patients that did not receive routine prophylactic dose of antibiotics in the operating room.

• Skin incisions other than Pfannenstiel

• Uterine incisions other than low transverse

• Patients with known or discovered allergy to silver or nylon

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cosmetic Appearance of Cesarean Scar
• Infection
• Pain, Postoperative
• Post-operative Pain
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Device:
• Silver Plated dressing
Silver plated dressing placed over Cesarean wound after skin closure, the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7
• Telfa pad dressing
Telfa pad dressing placed over Cesarean wound after skin closure, the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7

Locations

Country	Name	City	State
United States	Tampa General Hospital, Genesis At HealthPark	Tampa	Florida
United States	Tampa General Hospital, Women's Center, Labor and Delivery	Tampa	Florida
United States	USF Health, Morsani Center for Advanced Healthcare	Tampa	Florida
United States	USF Health, South Tampa Center for Advanced Healthcare	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Argentum Medical LLC

Country where clinical trial is conducted

United States, 

References & Publications (15)

. Clinical features and diagnosis of allergic contact dermatitis.http://www.uptodate.com /contents/clinical-features-and-diagnosis-of-allergic-contact dermatitis?source=search _result&search=clinical+features+and+diagnosis+of+allergic+contact&selectedTitle=2%7E150

10.Reducing Surgical Sites Infections: Http://www.infectioncontroltoday.com/articles/2008/03/reducing-surgical-site-infections.aspx, March 1, 2008.

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. — View Citation

Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010 Jul;203(1):36.e1-8. doi: 10.1016/j.ajog.2010.02.001. Epub 2010 Apr 24. — View Citation

Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. — View Citation

Epstein NE. Do silver-impregnated dressings limit infections after lumbar laminectomy with instrumented fusion? Surg Neurol. 2007 Nov;68(5):483-5; discussion 485. — View Citation

Huckfeldt R, Redmond C, Mikkelson D, Finley PJ, Lowe C, Robertson J. A clinical trial to investigate the effect of silver nylon dressings on mediastinitis rates in postoperative cardiac sternotomy incisions. Ostomy Wound Manage. 2008 Oct;54(10):36-41. — View Citation

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. — View Citation

Leaper DJ. Silver dressings: their role in wound management. Int Wound J. 2006 Dec;3(4):282-94. Review. — View Citation

Mustoe TA, Cooter RD, Gold MH, Hobbs FD, Ramelet AA, Shakespeare PG, Stella M, Téot L, Wood FM, Ziegler UE; International Advisory Panel on Scar Management. International clinical recommendations on scar management. Plast Reconstr Surg. 2002 Aug;110(2):560-71. Review. — View Citation

Olsen MA, Butler AM, Willers DM, Devkota P, Gross GA, Fraser VJ. Risk factors for surgical site infection after low transverse cesarean section. Infect Control Hosp Epidemiol. 2008 Jun;29(6):477-84; discussion 485-6. doi: 10.1086/587810. — View Citation

Opøien HK, Valbø 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. — View Citation

Owens SM, Brozanski BS, Meyn LA, Wiesenfeld HC. Antimicrobial prophylaxis for cesarean delivery before skin incision. Obstet Gynecol. 2009 Sep;114(3):573-9. doi: 10.1097/AOG.0b013e3181b490f1. — View Citation

Perkins James, Pattillo Rolandid. How to Avert Postoperative Wound Complications -Treat It when It Occurs. OBG Management 2009;21(10):43-53.

Thomas Steve. MRSA and the Use of Silver Dressings: Overcoming Bacterial Resistance. http://www.worldwidewounds.com/2004/november/Thomas/Introducing- Silver Dressings.html.

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain		Seven days post-operative	No
Other	Pain		Six weeks post-operative	No
Primary	Surgical site infection		Seven days postoperative	No
Primary	Surgical site infection		Six weeks post-operative	No
Secondary	Cosmetic appearance		Seven days post-operative	No
Secondary	Cosmetic appearance		Six weeks post-operative	No