NCT00600925

A Study of an Antibiotic Implant in General Surgical Subjects at Higher Risk for Surgical Wound Infection

A Randomized, Controlled, Phase 3 Study of Gentamicin-Collagen Sponge in General Surgical Subjects at Higher Risk for Surgical Wound Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 602 (actual)
• Sponsor: Innocoll · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective for preventing surgical wound infections in patients undergoing colorectal surgery.

Detailed description

Surgical wound infection (SWI) is a significant problem in colorectal surgery. Despite the use of routine bowel preparation and prophylactic antibiotics the incidence of SWI is at least 15% in patients undergoing colorectal surgical procedures.Therefore, there is a long unmet need for an intervention that can reduce the incidence and severity of SWIs in patients undergoing colorectal surgery. Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin-collagen sponge is a thin flat sponge made out of collagen that comes from cow tendons and containing gentamicin. When inserted into a surgical site, the collagen breaks down and the gentamicin is released at the site but very little is absorbed into the blood stream. The high levels of antibiotic at the surgical site may prevent an infection at the surgical site. Outside of the United States more than 3,500 subjects have received treatment in clinical studies with the gentamicin-collagen sponge, primarily for orthopedic, intraabdominal, and cardiothoracic surgeries or wound infections following surgical procedures or traumatic events. In this study, all subjects will be given treatment that is normally given to prevent surgical infections. For subjects randomly assigned to the gentamicin-collagen sponge treatment group, 2 sponges will be inserted into the surgical wound immediately before the surgeon closes it. The control group will receive no collagen sponge.

Conditions

• Colorectal Surgery
• Surgical Wound Infection

Interventions

Type	Name	Description
DRUG	gentamicin-collagen sponge dipped in saline	2 gentamicin-collagen sponges inserted before closure of the laparotomy

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-03-01
• Completion: 2010-09-01
• First posted: 2008-01-25
• Last updated: 2021-09-24
• Results posted: 2021-09-24

Locations

39 sites across 1 country: United States