NCT03443141

Effect of Vitamin E-containing Dressing on Surgical Site Infection in Colorectal Surgery

Effecto of Total Occlusive Vitamin E-containing Dressing on Incisional Surgical Site Infection in Elective Laparoscopic Colorectal Surgery

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hospital General Universitario Elche · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A prospective, randomized study will be performed. Patients are randomized using a 1:1 allocation into 2 groups: patients receiving a vitamin E-containing dressing (group 1) and a conventional dressing (group 2). The primary outcomes variable will be occurrence of incisional SSI. Follow-up will be 30 days postoperatively.

Detailed description

A prospective, randomized study will be performed. Patients are randomized using a random number table into 1:1 allocation into 2 groups: patients receiving a vitamin E-containing dressing (group 1) and a conventional dressing (group 2). In group 1 the wound will be covered with a Vitamin E embebbed gauze and plastic adhesive tape. In Group 2, , the wound will be covered with standard gauze and plastic adhesive tape. The primary outcomes variable will be occurrence of incisional SSI, defined by CDC criteria. Follow-up will be 30 days postoperatively.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	Vitamin E	The applied dressing will be embebbed in Vitamin E
DRUG	Standard dressing	The applied dressing is a normal one without adding any product to it.

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-03-30
• Completion: 2018-03-30
• First posted: 2018-02-22
• Last updated: 2018-02-22

Locations

1 site across 1 country: Spain