Negative Pressure Wound Therapy for Surgical Site Infection Prevention in Common Femoral Artery Exposure
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|ClinicalTrials.gov Identifier: NCT03935659|
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infection Groin Infections||Device: Negative Pressure Pressure Wound Therapy Procedure: Standard Wound Care||Not Applicable|
Eligible patients are randomized pre-operatively into either a standard dressing or NPWT for the groin incision.
- 1 The control group receive a standard sterile gauge dressing over the groin incision. The dressing is removed on post-operative day #2 and the wound is inspected for a SSI or dehiscence, followed by daily dressing changes and wound inspections until discharge.
- 2 The intervention group will receive a NPWT dressing which will be applied in the operating room under sterile conditions. The NPWT dressing will be removed on Post operative day 5. The wound is inspected for a SSI or dehiscence, followed by daily dressing changes and wound inspections until discharge.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patient fulfilling the inclusion criteria will be randomized into a standard gauze therapy group or a negative pressure wound therapy group.|
|Masking:||None (Open Label)|
|Masking Description:||As this intervention necessitated the use of an external negative wound therapy device, masking is not possible|
|Official Title:||Negative Pressure Wound Therapy for Surgical Site Infection Prevention in Vascular Surgery Patients Undergoing Common Femoral Artery Exposure|
|Actual Study Start Date :||March 26, 2018|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||October 1, 2021|
Active Comparator: Standard gauze therapy
The control group will receive a standard sterile gauge dressing over the groin incision. The dressing will be removed on post-operative day #2 and the wound will be inspected for any complications, followed by daily dressing changes and wound inspections until discharge.
Procedure: Standard Wound Care
Standard sterile gauze coverage of the primarily closed groin wound.
Experimental: Negative Pressure wound therapy
The intervention group will receive a negative pressure dressing which will be applied in the operating room under sterile conditions. The brand of negative pressure dressing will be based on surgeon preference or center availability. The NPWT dressing will be removed on day 5 postoperatively or at discharge, whichever occurs first, and the groin wound inspected for any evidence of infection or dehiscence, and daily thereafter until discharge.
Device: Negative Pressure Pressure Wound Therapy
Investigators will be using a Negative Pressure Wound Therapy Powered Suction Pump on primarily closed groin wounds after open common femoral artery exposure, The Negative pressure dressing will be applied in a sterile fashion in the operating room. The negative pressure dressing will be removed at day 5 postoperatively, or at discharge, whichever occurs first.
- Superficial surgical site infection [ Time Frame: 30 days postoperatively ]Surgical site infection as defined by the Center for disease control and prevention criteria
- Mortality [ Time Frame: 30 days ]Occurrence of mortality within 30 days of surgery
- Limb Loss [ Time Frame: 30 days and 1 year ]Occurrence of ipsilateral limb loss SSI within 30 days and 1 year of surgery
- Emergency department visit for wound complication [ Time Frame: within 30 days of surgery ]Number of participants returning to the emergency department for wound complications within 30 days of surgery
- Local reaction to negative wound dressing [ Time Frame: 5 days postoperatively ]Occurrence of a local reaction at the site of the negative pressure apparatus during application
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935659
|Contact: Loay Kabbani, MD||313-844-0246||LKABBAN1@hfhs.org|
|Contact: Ali Rteil, MDemail@example.com|
|United States, Michigan|
|Henry Ford Hospital||Recruiting|
|Detroit, Michigan, United States, 48202|
|Contact: Loay Kabbani, MD 313-844-0246 LKABBAN1@hfhs.org|
|Contact: Ali Rteil, MD 2024272899 firstname.lastname@example.org|
|Principal Investigator:||Loay Kabbani, MD||Henry Ford Health System|