Prospective Study on Cesarean Wound Outcomes

NCT01697748 | Completed Results

• 1 other identifier: USF IRB 00008650
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 3

Brief Summary

This study will investigate whether the placement of silver impregnated 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 impregnated dressings are used compared to the Telfa pads. The study will compare the percentage of patients who develop a surgical site infection after application of silver impregnated dressings versus standard Telfa dressings. Investigators will also assess the cosmetic appearance and pain of the cesarean section scar at the patient's one week and 6 week post-operative visits.

Conditions

Surgical Site Infection; Cosmetic Appearance of Cesarean Scar; Post Operative Pain

Keywords

cesarean section incisions; silver; c-section; wound infection; scar appearance; post operative pain

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Develop a Surgical Site Infection

  A surgical site infection involving the skin and subcutaneous tissue is defined as either * The presence of a purulent discharge from the wound on inspection, or * Purulent discharge obtained from the wound after exploration based on the suspicion of the provider (erythema, swelling, heat or pain), or * The presence of a seroma or hematoma discharge from the wound on inspection or after exploration that also involves isolation of an organism from an aseptically obtained culture based on suspicion of the provider (erythema, swelling, heat or pain). Seromas or hematomas with negative cultures will not be considered a surgical site infection.

  from post operative day #1 through post operative day 30

Secondary Outcomes (2)

• Cosmetic Outcome of the Cesarean Section Incision

  Post operative day 7

• Cosmetic Outcome of the Cesarean Section Incision

  Six weeks post-operative

Other Outcomes (3)

• Reduction of Pain After Cesarean Delivery

  Immediately post operatively to hospital discharge

• The Number of Participants Noting Pain at the One Week Post Cesarean Visit

  Post operative day 7

• The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit

  6 weeks post operative

Study Arms (2)

Telfa pad dressing

PLACEBO COMPARATOR

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.

Device: Telfa pad dressing

Silver-impregnated dressing

ACTIVE COMPARATOR

Silver-impregnated 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.

Device: Silver-impregnated dressing

Interventions

Silver-impregnated dressing DEVICE

Silver-impregnated 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.

Also known as: Silverlon

Silver-impregnated dressing

Telfa pad dressing DEVICE

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.

Also known as: Telfa pad

Telfa pad dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Elective and emergent cesarean deliveries
• Primary and repeat cesarean sections
• Transverse skin incisions (Pfannenstiel)
• Low transverse uterine incisions
• Patients with or without the diagnosis of chorioamnionitis with antibiotic treatment prior to or after the delivery of the baby
• Single and multiple gestations
• Able and willing to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (3)

USF Health South Tampa Center for Advanced Healthcare

Tampa, Florida, 33606, United States

Location

Women's Center Operating Rooms at the Tampa General Hospital

Tampa, Florida, 33606, United States

Location

USF Health Morsani Center for Advanced Healthcare

Tampa, Florida, 33612, United States

Location

Related Publications (13)

• 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: 17712651 BACKGROUND

• Owens SM, Brozanski BS, Meyn LA, Wiesenfeld HC. Antimicrobial prophylaxis for cesarean delivery before skin incision. Obstet Gynecol. 2009 Sep;114(3):573-579. doi: 10.1097/AOG.0b013e3181b490f1.

  PMID: 19701037 BACKGROUND

• 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.

  PMID: 18510455 BACKGROUND

• 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: 17961738 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 18927482 BACKGROUND

• Leaper DJ. Silver dressings: their role in wound management. Int Wound J. 2006 Dec;3(4):282-94. doi: 10.1111/j.1742-481X.2006.00265.x.

  PMID: 17199764 BACKGROUND

• Mustoe TA, Cooter RD, Gold MH, Hobbs FD, Ramelet AA, Shakespeare PG, Stella M, Teot 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. doi: 10.1097/00006534-200208000-00031.

  PMID: 12142678 BACKGROUND

• 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.

  PMID: 20417924 BACKGROUND

• 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. doi: 10.1097/01.prs.0000122207.28773.56.

  PMID: 15253184 BACKGROUND

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

  BACKGROUND

• Yiannias, James. Clinical features and diagnosis of allergic contact dermatitis. http://www.uptodate.com/contents/clinical-features-and-diagnosis-of-allergic-contact-dermatitis

  BACKGROUND

• Connery SA, Yankowitz J, Odibo L, Raitano O, Nikolic-Dorschel D, Louis JM. Effect of using silver nylon dressings to prevent superficial surgical site infection after cesarean delivery: a randomized clinical trial. Am J Obstet Gynecol. 2019 Jul;221(1):57.e1-57.e7. doi: 10.1016/j.ajog.2019.02.053. Epub 2019 Mar 5.

  PMID: 30849351 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection; Pain, Postoperative; Wound Infection

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr Sheila Connery, Associate Professor Obstetrics and Gynecology
• Organization: University of South Florida

sconnery@health.usf.edu

813-259-8542

Study Officials

• Sheila Connery, MD

  USF Health Morsani College of Medicine, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: October 2, 2012
• Study Start: September 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: May 1, 2018
• Last Updated: November 14, 2019
• Results First Posted: September 26, 2018

Record last verified: 2012-12

Locations

US (3)