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Study Summary
No. 2007-0836:.......Colorectal......Miguel A. Rodriguez-Bigas......Surgical Oncology
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Study Summary Title
Study Summary
Number:
2007-0836
Study Title:A Randomized, Controlled, Phase 3 Study of Gentamicin-Collagen Sponge (Collatamp® G) in General Surgical Subjects at Higher Risk for Surgical Wound Infection
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Physician New Patient Referral
Name:Miguel A. Rodriguez-BigasPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Surgical OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-6940
Contact us about clinical trials
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General Information
Disease Group:ColorectalSupported By:Innocoll
Phase of Study:Phase IIIReturn
Visit:
30 and 60 days post-op.
Treatment
Agents:
Collatamp GHome Care:N/A
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
7 days for surgery
Description/
Intervention:
The goal of this clinical research study is to learn if placing gentamicin
sponges in a surgical wound can help to prevent the surgical wound from
becoming infected. This type of sponge is called a Gentamicin-Collagen sponge
(Collatamp® G). In this study, for participants who are randomly assigned to
receive the study drug, two sponges are placed before closing the skin for
colon and/or rectal surgery.

The safety of the Gentamicin-Collagen sponge will also be studied.
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Study Objectives / Outcomes
Primary Objective
The primary objective is to establish the efficacy of gentamicin-collagen sponge (Collatamp G) in the prevention of Surgical wound infections (SWIs).

Secondary Objectives
Secondary objectives include evaluation of gentamicin-collagen sponge with regard to:
1) Safety
2) Efficacy
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Study Status Information
Study Activation / Registration Date:08/13/2008
IRB Review and Approval Date:02/11/2008
Study Type:Phase Iii
Recruitment Status:Terminated
Projected Accrual:600
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Scheduled to undergo non-emergent colon and/or rectal surgical procedures involving a laparotomy incision of approximately 7 cm in length or greater.

2) Have the capacity to understand and sign an informed consent form.

3) Are male or female and greater than or equal to 18 years of age.

4) Women of child-bearing potential must have a negative serum HCG assay prior to surgery, and will be willing to continue to use effective means of birth control for at least 60 days following surgery.

5) Patients agree to be available for evaluation from baseline until final evaluation at 60 days postsurgery.

Exclusion Criteria:1) Known history of hypersensitivity to gentamicin or bovine collagen

2) 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.

3) Undergoing a significant concomitant surgical procedure (e.g., hysterectomy). The following concomitant procedures are allowed: appendectomy, cholecystectomy, oophorectomy, liver biopsy/wedge resection (not liver resection).

4) Undergoing a laparoscopic, laparoscopic-assisted, or other minimally invasive surgical approach involving a laparotomy incision less than 7 cm. For example, hand assisted left colectomy is allowed as long as a 7 cm or greater laparotomy incision is used.

5) History of prior laparotomy within the last 60 days of this planned procedure.

6) Planned to undergo a second laparotomy or colorectal surgical procedure (e.g. colostomy or ileostomy takedown) within 60 days of this planned first procedure.

7) Evidence preoperatively of any of the following: sepsis, sever sepsis, or septic shock (note that systemic inflamatory response syndrome (SIRS) alone is not an exclusion criterium).

8) Current abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason.

9) Receiving antibiotic therapy within the 1 week prior to the date of surgery.

10) Preoperative evaluation suggests intra-abdominal process that might preclude full closure of the skin

11) History of ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer.

12) Recent history of significant drug or alcohol abuse

13) Preoperative prothrombin time (PT) greater than 1.5 times upper limit of normal

14) Pregnant, lactating, or of childbearing potential not practicing a birth control method with a high degree of reliability.

15) Postsurgical life expectancy less than or equal to 60 days, in the investigator's or sponsor's opinion.

16) Refusal to accept medically indicated blood products.

17) Previous participation in this or any other active Innocoll Gentamicin-Collagen Sponge study.

18) 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 devise within 60 days is anticipated.

19) 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).

20) Patients with anterior abdominal wall mesh that is not planned to be completely removed during the planned procedure

21) Presence of prosthetic cardiac valve

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Links
Registration Number: NCT00600925
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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