Andrew A. Shelton, M.D.
A Study of an Antibiotic Implant in General Surgical Subjects at Higher Risk for Surgical Wound Infection
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: gentamicin-collagen sponge
Phase:
Phase 3Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- 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:
o Left Hemicolectomy
o Transverse Colectomy
o Segmental/Sleeve Left Colon Resection
o Total Abdominal Colectomy With Ileorectal Anastomosis
o Total Abdominal Colectomy With Ileostomy
o Total Abdominal Proctocolectomy (Portion Of Specimen To Be Extracted Via Laparotomy)
o Low Anterior Resection
o Sigmoid Resection
o Non-Emergent Hartmann's Procedure
o Colotomy With Polypectomy Distal To Hepatic Flexure
o Colostomy Takedown Through Laparotomy (Not Peristomal) Incision
o Ileo-Pouch Anal Anastomosis
o 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.
Key Exclusion Criteria:
- Known history of hypersensitivity to gentamicin or bovine collage
- 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
- 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
Additional Study Details
Official Title:
A Randomized, Controlled, Phase 3 Study of Gentamicin-Collagen Sponge (Collatamp? G) in General Surgical Subjects at Higher Risk for Surgical Wound InfectionAnticipated start date:
9/30/2008Lead Sponsor:
Innocoll TechnologiesCollaborator(s):
- Premier Research Group plc
- Duke University
Investigator(s):
Study Type:
InterventionalPurpose:
PreventionAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- 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.
Secondary Outcomes:
- The effect of Collatamp G the on the proportion of patients with surgically treated surgical wound infections adjudicated by an independent blinded committee
- The effect of Collatamp G the on the proportion of patients with deep incisional surgical wound infection based on CDC criteria adjudicated by an independent blinded committee
- The effect of Collatamp G the on the proportion of patients with superficial incisional surgical wound infection based on CDC criteria adjudicated by an independent blinded committee
- The effect of Collatamp G the on type of pathogen/bacteriology
- The effect of Collatamp G the on the ASEPSIS score
- The effect of Collatamp G on length of hospital stay postoperatively
- The effect of Collatamp G on rehospitalization for surgical wound infection
- The effect of Collatamp G the total hospitalization related costs
- Serum gentamicin levels in subjects receiving gentamicin-collagen sponge
- Serum gentamicin levels in subjects receiving reapplication of gentamicin-collagen sponge in cases of early reoperation
- Subject self-reported assessment of pain and wound healing based on a structured wound healing questionnaire
- Change in serum creatinine from baseline to peak
- Incidence of reported serious and nonserious AEs, including, but not limited to, development of renal failure, ileus, anastomitic leakage, and small-bowel obstruction
- All-cause mortality
- Emergency Room and/or surgical office visits secondary to wound complaints
- The amount of pain medications administered
Total Number to be Enrolled:
600Total Number to be Enrolled at Stanford:
100More Information
Secondary ID(s):
- COR0007
- INN-SWI-002
- NCT00600925
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
6/4/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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