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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.
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 impregnated dressing.
The primary objective is to compare the percentage of patients who develop a surgical site infection between the two groups at the 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 plastic surgery investigator will also conduct a blinded assessment of cosmetic outcome by review of photographs taken of the wounds at 1-week and 6-weeks.The tertiary objective is to evaluate the amount of narcotic and non narcotic medicine consumed during the hospitalization and query the patient with regards to pain involving the cesarean wound at 1 and 6 week post-operative visits
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Develop a Surgical Site Infection | A surgical site infection involving the skin and subcutaneous tissue is defined as either
| from post operative day #1 through post operative day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic Outcome of the Cesarean Section Incision | The following instruments will be used to determine the cosmetic outcome: • The Modified Vancouver scar scale Range of scale values are from 0-12 (0 indicating a better outcome) | Post operative day 7 |
| Cosmetic Outcome of the Cesarean Section Incision |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Pain After Cesarean Delivery | The amount of narcotics measured in Morphine equivalent milligrams and non opioids administered during the cesarean delivery hospitalization were recorded | Immediately post operatively to hospital discharge |
| The Number of Participants Noting Pain at the One Week Post Cesarean Visit |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheila Connery, MD | USF Health Morsani College of Medicine, Department of Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USF Health South Tampa Center for Advanced Healthcare | Tampa | Florida | 33606 | United States | ||
| Women's Center Operating Rooms at the Tampa General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17712651 | Background | 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. | |
| 19701037 | 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. |
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3 patients were inadequately consented, two in the Silverlon dressing group and one in the Telfa dressing group
Recruitment was from September 2013 through June 2016. The 6 week post operative visits were completed August 2016.
Recruitment was at University of South Florida South Tampa Campus, Tampa General Hospital Healthpark Genesis and Tampa General Hospital Tampa Florida Labor and Delivery Triage.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Silver-impregnated Dressing | 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. Silver-impregnated dressing: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Who Develop a Surgical Site Infection | A surgical site infection involving the skin and subcutaneous tissue is defined as either
| Posted | Count of Participants | Participants | from post operative day #1 through post operative day 30 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Readmission to hospital | Skin and subcutaneous tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin reaction to adhesive | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sheila Connery, Associate Professor Obstetrics and Gynecology | University of South Florida | 813-259-8542 | sconnery@health.usf.edu |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D010149 | Pain, Postoperative |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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. |
|
|
The following instruments will be used to determine the cosmetic outcome • The Modified Observer Scar Assessment Scale Range of scale values is from 5 - 50 ( the lower the score the better the outcome) |
| Six weeks post-operative |
Pain response to notable pain at wound site during 7 day post operative visit Subjective self reporting pain as yes or no. |
| Post operative day 7 |
| The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit | Pain response to notable pain at wound site during 6 week post operative visit Subjective self reporting of pain as yes or no. | 6 weeks post operative |
| Tampa |
| Florida |
| 33606 |
| United States |
| USF Health Morsani Center for Advanced Healthcare | Tampa | Florida | 33612 | United States |
| 18510455 | 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. |
| 17961738 | 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. |
| Background | Perkins James, Pattillo Rolandid. How to Avert Postoperative Wound Complications-Treat It when It Occurs. OBG Management 2009;21(10):43-53. |
| 18927482 | 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. |
| 17199764 | 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. |
| 12142678 | 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. |
| 20417924 | 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. |
| 15253184 | 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. |
| 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 |
| 30849351 | Derived | 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. |
| Lost to Follow-up |
|
| BG001 | Silver-impregnated Dressing | 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. Silver-impregnated dressing: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Silver-impregnated Dressing | 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. Silver-impregnated dressing: 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. |
|
|
|
| Secondary | Cosmetic Outcome of the Cesarean Section Incision | The following instruments will be used to determine the cosmetic outcome: • The Modified Vancouver scar scale Range of scale values are from 0-12 (0 indicating a better outcome) | Posted | Mean | Standard Deviation | score on a scale | Post operative day 7 |
|
|
|
|
| Secondary | Cosmetic Outcome of the Cesarean Section Incision | The following instruments will be used to determine the cosmetic outcome • The Modified Observer Scar Assessment Scale Range of scale values is from 5 - 50 ( the lower the score the better the outcome) | Posted | Mean | Standard Deviation | score on a scale | Six weeks post-operative |
|
|
|
|
| Other Pre-specified | Reduction of Pain After Cesarean Delivery | The amount of narcotics measured in Morphine equivalent milligrams and non opioids administered during the cesarean delivery hospitalization were recorded | Posted | Median | Inter-Quartile Range | Morphine milligram equivalent | Immediately post operatively to hospital discharge |
|
|
|
| Other Pre-specified | The Number of Participants Noting Pain at the One Week Post Cesarean Visit | Pain response to notable pain at wound site during 7 day post operative visit Subjective self reporting pain as yes or no. | This was the number of participants that completed the form at their 7 day post- operative visit. | Posted | Count of Participants | Participants | Post operative day 7 |
|
|
|
|
| Other Pre-specified | The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit | Pain response to notable pain at wound site during 6 week post operative visit Subjective self reporting of pain as yes or no. | Posted | Count of Participants | Participants | 6 weeks post operative |
|
|
|
|
| 0 |
| 329 |
| 1 |
| 329 |
| 3 |
| 329 |
| EG001 | Silver-impregnated Dressing | 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. Silver-impregnated dressing: 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. | 0 | 328 | 2 | 328 | 2 | 328 |
The application was initiated in 12/12. A sponsor subsequently was identified with the addition of objectives to the study. After completion of the University Clinical Trials agreement by both parties and IRB notification, the clinical trials registration was completed with receipt in 8/13. Patients were then consented and the first randomized patient occurred 9/13.
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Mixed Models Analysis |
Chi Square, Fisher Exact, Student t-test, Wilcoxon-Mann-Whitney test |
| <.05 |
| 2-Sided |
| 95 |
| Superiority |
Besides the Chi Square, Fisher's Exact test, Student T-test, Wilcoxon-Mann-Whitney test and logistic regression were utilized where appropriate |