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Colorectal SurgeryPhase 3NCT00600925

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

A Phase 3 study testing gentamicin-collagen sponge dipped in saline in people with Colorectal Surgery and Surgical Wound Infection, run by Innocoll at 39 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Surgery, Surgical Wound Infection
What is being tested?
gentamicin-collagen sponge dipped in saline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
602 participants
Where
39 sitesUnited States
Study dates
Jan 2008to Sep 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • Evidence preoperatively of any of the following: sepsis, severe sepsis, or septic shock (note that SIRS alone is not an exclusion criterion)
  • 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.
  • Previous participation in this or any other active Innocoll Gentamicin-Collagen Sponge study.
  • Participation within 30 days before the start of this study in any experimental drug or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated.
  • Surgeon does not believe that it will be possible to insert 2 sponges above the fascia in the patient (e.g. in a very thin patient planned to have a small incision)
  • Patients with anterior abdominal wall mesh that is not planned to be completely removed during the planned procedure.
  • Presence of prosthetic cardiac valve.

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Study site

    Albany, New York

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Baltimore, Maryland

  • Study site

    Brooklyn, New York

  • Study site

    Burlington, Vermont

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Columbus, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Detroit, Michigan

  • Study site

    Duluth, Minnesota

  • Study site

    Durham, North Carolina

  • Study site

    Florence, Alabama

  • Study site

    Greensboro, North Carolina

  • Study site

    Hershey, Pennsylvania

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Laguna Hills, California

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Minneapolis, Minnesota

  • Study site

    Mobile, Alabama

  • Study site

    Nashville, Tennessee

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Portland, Oregon

  • Study site

    Seattle, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Stanford, California

  • Study site

    Syracuse, New York

  • Study site

    Tacoma, Washington

  • Study site

    Tampa, Florida

  • Study site

    Temple, Texas

  • Study site

    Weston, Florida

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
gentamicin-collagen sponge dipped in saline
Keywords
Colorectal surgery
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gentamicin-collagen sponge dipped in salineDrug

    2 gentamicin-collagen sponges inserted before closure of the laparotomy

Study groups in NCT00600925
Study groupRoleWhat they receive
1ExperimentalInsertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin).
Receives: Drug: gentamicin-collagen sponge dipped in saline
2No interventionStandard of care, ie, no gentamicin-collagen sponge.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

  1. Number of Participants Who Had Superficial Incisional Surgical Wound Infection

    Number of Participants who had superficial incisional surgical wound infection, based on CDC criteria adjudicated by an independent blinded committee

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

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

    The proportion of subjects who had deep incisional SWI, based on Centers for Disease Control and Prevention (CDC) criteria adjudicated by an independent blinded committee

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

  3. The Effect of the Gentamicin-collagen Sponge on the ASEPSIS Score

    Mean (SD) ASEPSIS Score Through 60 Days Postoperatively - brief assessment of surgical wound on post-operative Days 3, 4, 5, 6, and 7 (or discharge if earlier) and then questionnaire/phone call on post-operative Days 30 and 60. Score from each time point is added up and the mean score is reported. Used to compare antibiotic regimens for their effectiveness in preventing or treating wound sepsis, well-defined criteria for outcome are needed. A method of assessing wound healing has been devised that defines carefully the characteristics to be considered and how they are to be awarded points. Objective criteria are also included in the assessment. Points are given for the need for Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay (ASEPSIS). The higher the points the worse outcome. Maximum Points would be 60. Minimum points would be 0

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

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

    Measured: Immediate post operative period

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

    The effect of the gentamicin-collagen sponge on rehospitalization for surgical wound infection.

    Measured: Through 60 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionMar 2009
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
602 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00600925
Sponsor's protocol ID
INN-SWI-002
Status last verified
Sep 2021
First submitted
14 Jan 2008
Last updated
24 Sep 2021
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20825316

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gentamicin-collagen sponge dipped in saline in people with Colorectal Surgery and Surgical Wound Infection, run by Innocoll at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 60 (time frame: assessed at Postop Day 1, 2, 3, 7, 30 & 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00600925, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.

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