Prophylactic NPWT to Reduce SSI in Colorectal Surgery

Status Terminated

Clinical Trial Summary

The purpose of this study is to see if the Negative Pressure Wound Therapy (NPWT) system is effective and safe for the prevention of superficial and deep incisional surgical site infections (SSI) in high risk patients within 30 days after elective colorectal surgery. It has been shown that patients with an IBD, patients undergoing a reoperation or patients with certain comorbidities are at a higher risk of developing an SSI. The NPWT device is a wound dressing with a vacuum system that can be placed over abdominal wounds. The study will include up to 400 patients at this single site, where these high risk patients will be randomized to receive either one of two arms. The first arm involves the placement of the NPWT device in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures. The device would then be left on for 5 days. The second arm would be standard of care and would entail routine postoperative protocols. Subjects will then be seen once at a 30 day (± 7 days) follow-up visit to assess for the development of SSIs.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03661814
Study type	Interventional
Source	Icahn School of Medicine at Mount Sinai
Contact
Status	Terminated
Phase	N/A
Start date	August 13, 2018
Completion date	January 28, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05529173` - Povidone-Iodine for Nasal Decolonization	Phase 4
Recruiting	`NCT03295955` - Comparing Efficacy of Postoperative Oral Antibiotic Use in Trans-Oral Thyroidectomy	N/A
Not yet recruiting	`NCT05276687` - Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection	Phase 4
Completed	`NCT02776774` - Topical Antibiotic Treatment for Spine Surgical Site Infection
Terminated	`NCT00386477` - Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial	N/A
Not yet recruiting	`NCT03872544` - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting	`NCT05077592` - Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections	Phase 4
Completed	`NCT03148067` - Incidence and Risk Factors for Surgical Site Infection After Intramedullary Nailing of Femoral and Tibial Fractures
Enrolling by invitation	`NCT03880188` - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Completed	`NCT01890720` - Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section	N/A
Recruiting	`NCT06319235` - Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®	Phase 1/Phase 2
Completed	`NCT02919410` - Bacterial Colonization With and Without Iodophor-impregnated Adhesive Drapes in Hip Surgery: a Prospective, Randomized Trial	N/A
Completed	`NCT02020018` - Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection	N/A
Completed	`NCT01741649` - Clorhexidine Versus Povidone for the Prevention of Surgical Site Infection After Cesarean Section	N/A
Not yet recruiting	`NCT01457859` - Effectiveness of Triclosan Coated Sutures in Preventing Leg Wound Infection After Coronary Artery Bypass Surgery	Phase 4
Completed	`NCT01340534` - Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection	Phase 3
Completed	`NCT03365219` - Alexis O-Ring Wound Retractor for the Prevention of Post-cesarean Surgical Site Infections	N/A
Completed	`NCT01026259` - Local Warming of Surgical Incisions	Phase 3
Completed	`NCT03574090` - Study the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Infection in Colorectal Surgery	Phase 4
Completed	`NCT03199911` - Topical Antibiotic Prophylaxis for Eyelids	Phase 4