Clinical Trials Logo
  1. Home
  2. Surgical Wound Infection
  3. NCT00600925

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

Surgical Wound Infection Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00600925
Study type Interventional
Source Innocoll
Contact
Status Completed
Phase Phase 3
Start date January 2008
Completion date September 2010
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