A Study of an Antibiotic Implant in General Surgical Subjects at Higher Risk for Surgical Wound Infection
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 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 gentamicin-collagen sponges inserted before closure of the laparotomy
|
| No Intervention: 2 Standard of care, ie, no gentamicin-collagen sponge. |
Outcome Measures
Primary Outcome Measures
- Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 60 [assessed at Postop Day 1, 2, 3, 7, 30 & 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.
Secondary Outcome Measures
- Number of Participants Who Had Superficial Incisional Surgical Wound Infection [assessed at Postop Day 1, 2, 3, 7, 30 & 60]
Number of Participants who had superficial incisional surgical wound infection, based on CDC criteria adjudicated by an independent blinded committee
- 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 proportion of subjects who had deep incisional SWI, based on Centers for Disease Control and Prevention (CDC) criteria adjudicated by an independent blinded committee
- 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.]
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
- 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]
The effect of the gentamicin-collagen sponge on rehospitalization for surgical wound infection.
Eligibility Criteria
Criteria
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: 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.
Exclusion Criteria:
-
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.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Florence | Alabama | United States | ||
| 2 | Mobile | Alabama | United States | ||
| 3 | Laguna Hills | California | United States | ||
| 4 | Los Angeles | California | United States | ||
| 5 | Stanford | California | United States | ||
| 6 | Aurora | Colorado | United States | ||
| 7 | Denver | Colorado | United States | ||
| 8 | Tampa | Florida | United States | ||
| 9 | Weston | Florida | United States | ||
| 10 | Atlanta | Georgia | United States | ||
| 11 | Indianapolis | Indiana | United States | ||
| 12 | Louisville | Kentucky | United States | ||
| 13 | New Orleans | Louisiana | United States | ||
| 14 | Baltimore | Maryland | United States | ||
| 15 | Detroit | Michigan | United States | ||
| 16 | Duluth | Minnesota | United States | ||
| 17 | Minneapolis | Minnesota | United States | ||
| 18 | Saint Louis | Missouri | United States | ||
| 19 | Albany | New York | United States | ||
| 20 | Brooklyn | New York | United States | ||
| 21 | New York | New York | United States | ||
| 22 | Syracuse | New York | United States | ||
| 23 | Chapel Hill | North Carolina | United States | ||
| 24 | Durham | North Carolina | United States | ||
| 25 | Greensboro | North Carolina | United States | ||
| 26 | Cincinnati | Ohio | United States | ||
| 27 | Cleveland | Ohio | United States | ||
| 28 | Columbus | Ohio | United States | ||
| 29 | Oklahoma City | Oklahoma | United States | ||
| 30 | Portland | Oregon | United States | ||
| 31 | Hershey | Pennsylvania | United States | ||
| 32 | Philadelphia | Pennsylvania | United States | ||
| 33 | Nashville | Tennessee | United States | ||
| 34 | Dallas | Texas | United States | ||
| 35 | Houston | Texas | United States | ||
| 36 | Temple | Texas | United States | ||
| 37 | Burlington | Vermont | United States | ||
| 38 | Seattle | Washington | United States | ||
| 39 | Tacoma | Washington | United States |
Sponsors and Collaborators
- Innocoll
- Duke University
- Premier Research Group plc
Investigators
- Study Director: David Prior, Innocoll
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- INN-SWI-002
- NCT01150773
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Gentamicin Group | Control |
|---|---|---|
| Arm/Group Description | 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). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy | Standard of care, ie, no gentamicin-collagen sponge. |
| Period Title: Overall Study | ||
| STARTED | 300 | 302 |
| COMPLETED | 300 | 302 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Gentamicin Group Group | Control Group | Total |
|---|---|---|---|
| Arm/Group Description | 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). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy | Standard of care, ie, no gentamicin-collagen sponge. | Total of all reporting groups |
| Overall Participants | 300 | 302 | 602 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
56.9
(15.36)
|
56.5
(15.81)
|
56.7
(15.57)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
181
60.3%
|
158
52.3%
|
339
56.3%
|
| Male |
119
39.7%
|
144
47.7%
|
263
43.7%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
2
0.7%
|
6
2%
|
8
1.3%
|
| Native Hawaiian or Other Pacific Islander |
2
0.7%
|
0
0%
|
2
0.3%
|
| Black or African American |
22
7.3%
|
19
6.3%
|
41
6.8%
|
| White |
272
90.7%
|
273
90.4%
|
545
90.5%
|
| More than one race |
2
0.7%
|
4
1.3%
|
6
1%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 60 |
|---|---|
| Description | 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. |
| Time Frame | assessed at Postop Day 1, 2, 3, 7, 30 & 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population |
| Arm/Group Title | Gentamicin Group | Control |
|---|---|---|
| Arm/Group Description | 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). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy | Standard of care, ie, no gentamicin-collagen sponge. |
| Measure Participants | 300 | 302 |
| Count of Participants [Participants] |
90
30%
|
63
20.9%
|
| Title | Number of Participants Who Had Superficial Incisional Surgical Wound Infection |
|---|---|
| Description | Number of Participants who had superficial incisional surgical wound infection, based on CDC criteria adjudicated by an independent blinded committee |
| Time Frame | assessed at Postop Day 1, 2, 3, 7, 30 & 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Gentamicin Group | Control |
|---|---|---|
| Arm/Group Description | 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). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy | Standard of care, ie, no gentamicin-collagen sponge. |
| Measure Participants | 300 | 302 |
| Count of Participants [Participants] |
61
20.3%
|
41
13.6%
|
| Title | The Effect of the Gentamicin-collagen Sponge on the Proportion of Patients With Deep Incisional Surgical Wound Infection |
|---|---|
| Description | 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 |
| Time Frame | assessed at Postop Day 1, 2, 3, 7, 30 & 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population |
| Arm/Group Title | Gentamicin Group | Control |
|---|---|---|
| Arm/Group Description | 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). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy | Standard of care, ie, no gentamicin-collagen sponge. |
| Measure Participants | 300 | 302 |
| Count of Participants [Participants] |
25
8.3%
|
18
6%
|
| Title | The Effect of the Gentamicin-collagen Sponge on the ASEPSIS Score |
|---|---|
| Description | 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 |
| Time Frame | Days 3, 4, 5, 6, and 7 (or discharge if earlier) and then questionnaire/phone call on post-operative Days 30 and 60. |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population |
| Arm/Group Title | Gentamicin Group | Control |
|---|---|---|
| Arm/Group Description | 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). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy | Standard of care, ie, no gentamicin-collagen sponge. |
| Measure Participants | 299 | 299 |
| Mean (Standard Deviation) [score on a scale] |
6.1
(10.38)
|
5.2
(10.99)
|
| Title | The Effect of the Gentamicin-collagen Sponge on Length of Hospital Stay Postoperatively. |
|---|---|
| Description | |
| Time Frame | Immediate post operative period |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population |
| Arm/Group Title | Gentamicin Group | Control |
|---|---|---|
| Arm/Group Description | 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). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy | Standard of care, ie, no gentamicin-collagen sponge. |
| Measure Participants | 300 | 302 |
| Mean (Standard Deviation) [days] |
7.5
(6.19)
|
7.3
(5.42)
|
| Title | Number of Participants Who Were Rehospitalized for Surgical Wound Infection Within 60 Days Post-operatively |
|---|---|
| Description | The effect of the gentamicin-collagen sponge on rehospitalization for surgical wound infection. |
| Time Frame | Through 60 days after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population |
| Arm/Group Title | Gentamicin Group | Control |
|---|---|---|
| Arm/Group Description | 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). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy | Standard of care, ie, no gentamicin-collagen sponge. |
| Measure Participants | 300 | 302 |
| Count of Participants [Participants] |
21
7%
|
13
4.3%
|
Adverse Events
| Time Frame | Subjects remained enrolled into the study until 60 days post-operatively | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients. | |||
| Arm/Group Title | Gentamicin Group Group | Control Group | ||
| Arm/Group Description | 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). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy | Standard of care, ie, no gentamicin-collagen sponge. | ||
All Cause Mortality |
||||
| Gentamicin Group Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/296 (0.3%) | 5/306 (1.6%) | ||
Serious Adverse Events |
||||
| Gentamicin Group Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 114/296 (38.5%) | 101/306 (33%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/296 (0.3%) | 1 | 1/306 (0.3%) | 1 |
| Pernicious anaemia | 1/296 (0.3%) | 1 | 1/306 (0.3%) | 1 |
| Splenic infarcation | 1/296 (0.3%) | 1 | 1/306 (0.3%) | 1 |
| Cardiac disorders | ||||
| Acute myocardial infarction | 0/296 (0%) | 0 | 2/306 (0.7%) | 2 |
| Atrial Fibrillation | 3/296 (1%) | 3 | 1/306 (0.3%) | 1 |
| Myocardial infarction | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Supraventricular tachycardia | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Tachycardia | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Myocardial ischaemia | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/296 (0.3%) | 1 | 2/306 (0.7%) | 2 |
| Colonic fistula | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Crohn's disease | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Diarrhoea | 1/296 (0.3%) | 1 | 1/306 (0.3%) | 1 |
| Duodenal ulcer perforation | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Enterocutaneous fistula | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Faecal volume increased | 1/296 (0.3%) | 1 | 2/306 (0.7%) | 2 |
| Faecaloma | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Gastric hypomotility | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Gastrointestinal haemorrhage | 2/296 (0.7%) | 2 | 0/306 (0%) | 0 |
| Gastrointestinal hypomotility | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Gastrointestinal motility disorder | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Ileal perforation | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Inguinal hernia strangulated | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Intestinal obstruction | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Intestinal perforation | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Intra-abdominal haematoma | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Intra-abdominal haemorrhage | 1/296 (0.3%) | 1 | 2/306 (0.7%) | 2 |
| Large intestine perforation | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Lower gastrointestinal haemorrhage | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Mesenteric panniculitis | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Nausea | 0/296 (0%) | 0 | 2/306 (0.7%) | 2 |
| Peritonitis | 1/296 (0.3%) | 1 | 1/306 (0.3%) | 1 |
| Proctalgia | 2/296 (0.7%) | 2 | 0/306 (0%) | 0 |
| Rectal haemorrhage | 4/296 (1.4%) | 4 | 0/306 (0%) | 0 |
| Reflux oesophagitis | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Small intestinal obstruction | 8/296 (2.7%) | 8 | 10/306 (3.3%) | 10 |
| Vomiting | 3/296 (1%) | 3 | 1/306 (0.3%) | 1 |
| General disorders | ||||
| Non-cardiac chest pain | 1/296 (0.3%) | 1 | 1/306 (0.3%) | 1 |
| Pyrexia | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Hepatobiliary disorders | 6/296 (2%) | 6 | 1/306 (0.3%) | 1 |
| Cholecystitis | 1/296 (0.3%) | 1 | 1/306 (0.3%) | 1 |
| Cholecystitis acute | 3/296 (1%) | 3 | 0/306 (0%) | 0 |
| Portal vein thrombosis | 2/296 (0.7%) | 2 | 0/306 (0%) | 0 |
| Infections and infestations | ||||
| abdominal abcess | 2/296 (0.7%) | 2 | 3/306 (1%) | 3 |
| Abdominal infection | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Abdominal sepsis | 1/296 (0.3%) | 1 | 1/306 (0.3%) | 1 |
| Abdominal wall infection | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Bacteraemia | 0/296 (0%) | 0 | 2/306 (0.7%) | 2 |
| Catheter site infection | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Central line infection | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Clostridium difficile colitis | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Diverticulitis | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Emphysematous cholecystitis | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Endocarditis bacterial | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Fungaemia | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Gastroenteritis | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Haematoma infection | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Pelvic abscess | 9/296 (3%) | 9 | 7/306 (2.3%) | 7 |
| Pelvic infection | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Pelvic sepsis | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Pneumonia | 2/296 (0.7%) | 2 | 2/306 (0.7%) | 2 |
| Post procedural cellulitis | 1/296 (0.3%) | 1 | 1/306 (0.3%) | 1 |
| Postoperative abscess | 3/296 (1%) | 3 | 1/306 (0.3%) | 1 |
| Postoperative wound infection | 19/296 (6.4%) | 19 | 7/306 (2.3%) | 7 |
| Rectal abscess | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Sepsis | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Septic shock | 1/296 (0.3%) | 1 | 1/306 (0.3%) | 1 |
| Soft tissue infection | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Staphylococcal infection | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Abdominal wound dehiscence | 7/296 (2.4%) | 7 | 3/306 (1%) | 3 |
| Anastomotic stenosis | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Deep vein thrombosis postoperative | 2/296 (0.7%) | 2 | 0/306 (0%) | 0 |
| Femoral neck fracture | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Gastrointestinal anastomotic leak | 8/296 (2.7%) | 8 | 4/306 (1.3%) | 4 |
| Gastrointestinal stoma complication | 0/296 (0%) | 0 | 4/306 (1.3%) | 4 |
| Intestinal anastomosis complication | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Jaw fracture | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Post procedural complication | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Post procedural discharge | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Postoperative ileus | 30/296 (10.1%) | 30 | 19/306 (6.2%) | 19 |
| Postoperative wound complication | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Seroma | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Therapeutic agent toxicity | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Ulna fracture | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Ureteric injury | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Urethral injury | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Urinary retention postoperative | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Wound dehiscence | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Wound evisceration | 1/296 (0.3%) | 1 | 2/306 (0.7%) | 2 |
| wound secretion | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| investigations | 1/296 (0.3%) | 1 | 1/306 (0.3%) | 1 |
| Aspiration bronchial | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| international normalised ration decrease | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 14/296 (4.7%) | 14 | 9/306 (2.9%) | 9 |
| Electrolyte imbalance | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Hyperkalaemia | 0/296 (0%) | 0 | 3/306 (1%) | 3 |
| Hyponatraemia | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Hypovolaemia | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Malnutrition | 4/296 (1.4%) | 4 | 0/306 (0%) | 0 |
| Metabolic acidosis | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/296 (0.7%) | 2 | 1/306 (0.3%) | 1 |
| Colon cancer metastatic | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Hepatic neoplasm | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Metastatic neoplasm | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Nervous system disorders | 1/296 (0.3%) | 1 | 3/306 (1%) | 3 |
| Cerebrovascular accident | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Paraplegia | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Syncope | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Thalamic infarction | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Psychiatric disorders | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Confusional state | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Renal and urinary disorders | ||||
| Calculus ureteric | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Haematuria | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Hydronephrosis | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Renal disorder | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Renal failure | 0/296 (0%) | 0 | 2/306 (0.7%) | 2 |
| Renal failure acute | 3/296 (1%) | 3 | 3/306 (1%) | 3 |
| Renal failure chronic | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Renal infarct | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Renal tubular necrosis | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Urinary retention | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Female genital tract fistula | 1/296 (0.3%) | 1 | 3/306 (1%) | 3 |
| Pelvic haematoma | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Vaginal haemorrhage | 1/296 (0.3%) | 1 | 1/306 (0.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute respiratory failure | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Atelectasis | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Laryngospasm | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Pneumothorax | 1/296 (0.3%) | 1 | 1/306 (0.3%) | 1 |
| Pulmonary embolism | 1/296 (0.3%) | 1 | 3/306 (1%) | 3 |
| Pulmonary oedema | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Respiratory acidosis | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Respiratory depression | 1/296 (0.3%) | 1 | 0/306 (0%) | 0 |
| Respiratory distress | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Respiratory failure | 3/296 (1%) | 3 | 0/306 (0%) | 0 |
| Vascular disorders | ||||
| Deep vein thrombosis | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Haematoma | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Haemorrhage | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
| Hypotension | 0/296 (0%) | 0 | 1/306 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Gentamicin Group Group | Control Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 294/296 (99.3%) | 302/306 (98.7%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 70/296 (23.6%) | 70 | 51/306 (16.7%) | 51 |
| Leukocytosis | 17/296 (5.7%) | 17 | 14/306 (4.6%) | 14 |
| Cardiac disorders | ||||
| Tachycardia | 46/296 (15.5%) | 46 | 46/306 (15%) | 46 |
| Gastrointestinal disorders | ||||
| Abdominal Distension | 70/296 (23.6%) | 70 | 73/306 (23.9%) | 73 |
| Abdominal pain | 71/296 (24%) | 71 | 81/306 (26.5%) | 81 |
| Diarrhoea | 23/296 (7.8%) | 23 | 13/306 (4.2%) | 13 |
| Nausea | 167/296 (56.4%) | 167 | 191/306 (62.4%) | 191 |
| Vomiting | 98/296 (33.1%) | 98 | 79/306 (25.8%) | 79 |
| General disorders | ||||
| Fatigue | 16/296 (5.4%) | 16 | 16/306 (5.2%) | 16 |
| Oedema Peripheral | 18/296 (6.1%) | 18 | 21/306 (6.9%) | 21 |
| Pyrexia | 57/296 (19.3%) | 57 | 59/306 (19.3%) | 59 |
| Infections and infestations | ||||
| Post-operative Wound infection | 47/296 (15.9%) | 47 | 35/306 (11.4%) | 35 |
| Urinary Tract Infection | 22/296 (7.4%) | 22 | 32/306 (10.5%) | 32 |
| Injury, poisoning and procedural complications | ||||
| Abdominal Wound Dehiscence | 34/296 (11.5%) | 34 | 17/306 (5.6%) | 17 |
| Incision Site Pain | 119/296 (40.2%) | 119 | 122/306 (39.9%) | 122 |
| Post procedural Discharge | 57/296 (19.3%) | 57 | 42/306 (13.7%) | 42 |
| Post-operative Ileus | 23/296 (7.8%) | 23 | 31/306 (10.1%) | 31 |
| Post-operative Wound Complication | 33/296 (11.1%) | 33 | 41/306 (13.4%) | 41 |
| Procedural Pain | 81/296 (27.4%) | 81 | 77/306 (25.2%) | 77 |
| Investigations | ||||
| Blood Glucose Increased | 16/296 (5.4%) | 16 | 18/306 (5.9%) | 18 |
| Body Temperature Increased | 24/296 (8.1%) | 24 | 21/306 (6.9%) | 21 |
| Breath Sounds Abnorma | 26/296 (8.8%) | 26 | 18/306 (5.9%) | 18 |
| Urine Output Decreased | 25/296 (8.4%) | 25 | 19/306 (6.2%) | 19 |
| White Blood Cell Count Increased | 26/296 (8.8%) | 26 | 18/306 (5.9%) | 18 |
| Metabolism and nutrition disorders | ||||
| Decreased Appetite | 18/296 (6.1%) | 18 | 18/306 (5.9%) | 18 |
| Dehydration | 16/296 (5.4%) | 16 | 14/306 (4.6%) | 14 |
| Hyperglycaemia | 21/296 (7.1%) | 21 | 20/306 (6.5%) | 20 |
| Hypokalaemia | 49/296 (16.6%) | 49 | 45/306 (14.7%) | 45 |
| Hypomagnesaemia | 35/296 (11.8%) | 35 | 28/306 (9.2%) | 28 |
| Musculoskeletal and connective tissue disorders | ||||
| Back Pain | 15/296 (5.1%) | 15 | 22/306 (7.2%) | 22 |
| Nervous system disorders | ||||
| Dizziness | 33/296 (11.1%) | 33 | 33/306 (10.8%) | 33 |
| Headache | 16/296 (5.4%) | 16 | 23/306 (7.5%) | 23 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 15/296 (5.1%) | 15 | 18/306 (5.9%) | 18 |
| Skin and subcutaneous tissue disorders | ||||
| Pruritus | 22/296 (7.4%) | 22 | 23/306 (7.5%) | 23 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management |
|---|---|
| Organization | Innocoll |
| Phone | 484-406-5211 |
| ctucker@innocoll.com |
- INN-SWI-002
- NCT01150773