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

NCT00600925 | Completed Phase 3 Results DMC

• 1 other identifier: INN-SWI-002
• Study Type: interventional
• Target: 602
• Locations: 1 country
• Sites: 39

Brief 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.

Conditions

Colorectal Surgery; Surgical Wound Infection

Keywords

Colorectal surgery

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 60

  Primarily, efficacy will be evaluated by a comparison between the 2 study groups of the incidence of surgical wound infections (involving the laparotomy incision) that occur within the period from surgery through postop day 60.

  assessed at Postop Day 1, 2, 3, 7, 30 & 60

Secondary Outcomes (5)

• Number of Participants Who Had Superficial Incisional Surgical Wound Infection

  assessed at Postop Day 1, 2, 3, 7, 30 & 60

• The Effect of the Gentamicin-collagen Sponge on the Proportion of Patients With Deep Incisional Surgical Wound Infection

  assessed at Postop Day 1, 2, 3, 7, 30 & 60

• The Effect of the Gentamicin-collagen Sponge on the ASEPSIS Score

  Days 3, 4, 5, 6, and 7 (or discharge if earlier) and then questionnaire/phone call on post-operative Days 30 and 60.

• The Effect of the Gentamicin-collagen Sponge on Length of Hospital Stay Postoperatively.

  Immediate post operative period

• Number of Participants Who Were Rehospitalized for Surgical Wound Infection Within 60 Days Post-operatively

  Through 60 days after surgery

Study Arms (2)

1

EXPERIMENTAL

Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin).

Drug: gentamicin-collagen sponge dipped in saline

2

NO INTERVENTION

Standard of care, ie, no gentamicin-collagen sponge.

Interventions

gentamicin-collagen sponge dipped in saline DRUG

2 gentamicin-collagen sponges inserted before closure of the laparotomy

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo nonemergent colon and/or rectal surgical procedures involving a laparotomy incision of at least 7 cm in length or greater. List of eligible procedures: Left Hemicolectomy, Transverse Colectomy, Segmental/Sleeve Left Colon Resection, Total Abdominal Colectomy With Ileorectal Anastomosis, Total Abdominal Colectomy With Ileostomy, Total Abdominal Proctocolectomy (Portion Of Specimen To Be Extracted Via Laparotomy), Low Anterior Resection, Sigmoid Resection, Non-Emergent Hartmann's Procedure, Colotomy With Polypectomy Distal To Hepatic Flexure, Colostomy Takedown Through Laparotomy (Not Peristomal) Incision, Ileo-Pouch Anal Anastomosis, Abdominal Perineal Resection of the Rectum
• Have the capacity to understand and sign an informed consent form.
• Are male or female and \> 18 years of age.
• If female, be postmenopausal (no menstrual period for a minimum of 1 year), or surgically sterilized (does not have a uterus or has had bilateral tubal ligation). Females of child-bearing potential must have a negative serum pregnancy test on entry in the study, and agree to use adequate birth control during the study and for 60 days after the administration of study agent.
• Agree to be available for evaluation from baseline until final evaluation at 60 days postsurgery.

You may not qualify if:

• Known history of hypersensitivity to gentamicin or bovine collagen.
• Undergoing emergency surgery (urgent surgery is allowed if informed consent is obtained and the study procedures can be performed). Emergency surgery includes cases where standard bowel preparation and other preoperative assessments cannot be done.
• Undergoing a significant concomitant surgical procedure (e.g., hysterectomy). The following concomitant procedures are allowed: appendectomy, cholecystectomy, oophorectomy, liver biopsy/wedge resection (but not liver resection).
• Undergoing a laparoscopic, laparoscopic-assisted, or other minimally invasive surgical approach involving a laparotomy incision less than 7 cm.
• History of prior laparotomy within the last 60 days of this planned procedure.
• Planned to undergo a second laparotomy or colorectal surgical procedure (e.g. colostomy or ileostomy takedown) within 60 days of this planned first procedure.
• Current abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason.
• Receiving antibiotic therapy within the 1 week prior to the date of surgery.
• Preoperative evaluation suggests intra-abdominal process that might preclude full closure of the skin.
• History of ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer.
• Recent history of significant drug or alcohol abuse.
• Preoperative prothrombin time (PT) \> 1.5 times upper limit of normal
• Pregnant, lactating, or of childbearing potential not practicing a birth control method with a high degree of reliability
• Postsurgical life expectancy ≤ 60 days, in the investigator's or sponsor's opinion.
• Refusal to accept medically indicated blood products.

Sponsors & Collaborators

• Innocoll: lead
• Duke University: collaborator
• Premier Research: collaborator

Study Sites (39)

Unknown Facility

Florence, Alabama, United States

Location

Unknown Facility

Mobile, Alabama, United States

Location

Unknown Facility

Laguna Hills, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Stanford, California, United States

Location

Unknown Facility

Aurora, Colorado, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Weston, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Louisville, Kentucky, United States

Location

Unknown Facility

New Orleans, Louisiana, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Duluth, Minnesota, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Albany, New York, United States

Location

Unknown Facility

Brooklyn, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Syracuse, New York, United States

Location

Unknown Facility

Chapel Hill, North Carolina, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Greensboro, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Hershey, Pennsylvania, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Temple, Texas, United States

Location

Unknown Facility

Burlington, Vermont, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Tacoma, Washington, United States

Location

Related Publications (1)

• Bennett-Guerrero E, Pappas TN, Koltun WA, Fleshman JW, Lin M, Garg J, Mark DB, Marcet JE, Remzi FH, George VV, Newland K, Corey GR; SWIPE 2 Trial Group. Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery. N Engl J Med. 2010 Sep 9;363(11):1038-49. doi: 10.1056/NEJMoa1000837. Epub 2010 Aug 4.

  PMID: 20825316 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management
• Organization: Innocoll

ctucker@innocoll.com

484-406-5211

Study Officials

• David Prior

  Innocoll

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 25, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: September 1, 2010
• Last Updated: September 24, 2021
• Results First Posted: September 24, 2021

Record last verified: 2021-09

Locations

US (39)