Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery

• Sponsor: Dr. Reddy's Laboratories Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01888367
• Collaborator: Duke Clinical Research Institute (Other)
• Enrollment: 445
• Locations: 31
• Arms: 3
• Duration (Months): 16
• Patients Per Site: 14.4
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This is a randomized, blinded, placebo and standard of care controlled study of the efficacy of a novel antibiotic containing gel compared to placebo gel in preventing surgical site infection after abdominal surgery. patients will be randomized to active or placebo gel in a double-blind manner. The gel will be applied a single time in the incision during closure at the end of surgery. A cohort of patients will also be randomized to standard of care, saline irrigation at prior to skin closure, in an open manner. The efficacy, safety and tolerability of the active gel will be assessed compared to the control group (combined placebo gel and standard of care groups). Patients will be randomized to DFA-02 active gel: placebo gel: standard of care in a 4:1:1 ratio.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infections	Drug: DFA-02 Antibiotic Gel; Drug: DFA-02 Placebo Gel	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 445 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Randomized, Blinded, Placebo and Standard of Care Controlled Efficacy, Safety, and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DFA-02 Antibiotic Gel Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.	Drug: DFA-02 Antibiotic Gel
Placebo Comparator: DFA-02 Placebo Gel Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.	Drug: DFA-02 Placebo Gel
No Intervention: Standard of Care Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Surgical Site Infections [Within 30 days of surgery]

Secondary Outcome Measures

1. Number of Patients With Adverse Events [Within 30 days of surgery]

2. Change in Serum Creatinine Measurements From Baseline [Within 4 days of surgery]

   Change from baseline in micromoles/liter

3. Cumulative ASEPSIS Score for Each Patient [Through post-operative Day 4]

   Total ASEPSIS score with a range of 0-65 points with lower scores being better. The score is the sum of: Antibiotic Use (10 points), Drainage of Pus Under Local Anesthesia (5 points), Debridement Under General Anesthesia (10 points), Serous Discharge (5 points), Erythema (5 points), Purulent Exudate (5 points), Separation of Deep Tissues (10 points) and Isolation of Bacteria from Discharge (10 points). Source: Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. Lancet. 1986:1(8476):311-3.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Males and females 18 years of age or older;

2. If female, the subject must be postmenopausal, surgically sterilized or, if of child-bearing potential, she must have a negative serum or urine pregnancy test within 48 hours of surgery and agree to use adequate birth control during the study and for 30 days after the administration of study agent;

3. Body mass index (BMI) ≥ 20;

4. Scheduled to undergo non-emergent abdominal surgery involving a planned incision of 7 cm or greater;

5. Willing and able to give informed consent;

6. Available for evaluation from Baseline until final evaluation at 30 days post-surgery.

Exclusion Criteria:

1. Known hypersensitivity to gentamicin, vancomycin, other aminoglycoside antibiotics or the excipients of the study products;

2. Emergency surgery;

3. Significant concomitant surgical procedure;

4. Prior laparotomy within the last 60 days of the planned procedure;

5. Planned second laparotomy or abdominal surgical procedure within 30 days of the planned first procedure;

6. Expectation that a surgical drain will be placed in the incision;

7. Preoperative sepsis, severe sepsis, or septic shock;

8. Abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason;

9. Active systemic infection or systemic (oral or intravenous) antibiotic therapy within the 1 week prior to the date of surgery other than specified preoperative antimicrobial prophylaxis;

10. Requirement for gentamicin or vancomycin preoperative antimicrobial prophylaxis;

11. Concurrent systemic use of other potentially neurotoxic, nephrotoxic, and/or ototoxic drugs;

12. Preoperative evaluation suggesting an intra-abdominal process that might preclude full closure of the skin;

13. Ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer;

14. History of significant drug or alcohol abuse;

15. Serum Creatinine > 1.8 mg/dL;

16. Serum Bilirubin > 2.5 times upper limit of normal;

17. Subjects who are immunocompromised including but not limited to systemic corticosteroid use or chemotherapy/radiation during the 30 days prior to surgery, organ transplantation, or HIV infection;

18. Known history of HIV;

19. Pregnant or lactating, or if of childbearing potential not practicing a birth control method with a high degree of reliability;

20. Refusal to accept medically indicated blood products;

21. 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;

22. Unable to participate in the study for any reason in the opinion of the Principal Investigator;

23. Postsurgical life expectancy of less than 30 days;

24. Expected discharge from the hospital less than 3 days after surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Florence	Alabama	United States
2		Sheffield	Alabama	United States
3		Phoenix	Arizona	United States
4		Tucson	Arizona	United States
5		Laguna Hills	California	United States
6		Los Angeles	California	United States
7		Aurora	Colorado	United States
8		Washington	District of Columbia	United States
9		Jacksonville	Florida	United States
10		Miami	Florida	United States
11		Tampa	Florida	United States
12		Weston	Florida	United States
13		Columbus	Georgia	United States
14		Powder Springs	Georgia	United States
15		Indianaoplis	Indiana	United States
16		Alexandria	Louisiana	United States
17		New Orleans	Louisiana	United States
18		Burlington	Massachusetts	United States
19		Worcester	Massachusetts	United States
20		Minneapolis	Minnesota	United States
21		Jackson	Mississippi	United States
22		Las Vegas	Nevada	United States
23		Albany	New York	United States
24		New York	New York	United States
25		Chapel Hill	North Carolina	United States
26		Columbus	Ohio	United States
27		Oklahoma City	Oklahoma	United States
28		Hershey	Pennsylvania	United States
29		Bellaire	Texas	United States
30		Nassau Bay	Texas	United States
31		Burlington	Vermont	United States

Sponsors and Collaborators

• Dr. Reddy's Laboratories Limited
• Duke Clinical Research Institute

Investigators

• Study Director: Elliott Bennett-Guerrero, MD, Duke Clinical Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Reddy's Laboratories Limited
• ClinicalTrials.gov Identifier: NCT01888367
• Other Study ID Numbers: DFA-02-CD-005
• First Posted: Jun 27, 2013
• Last Update Posted: Oct 11, 2016
• Last Verified: Aug 1, 2016

• Additional relevant MeSH terms: Surgical Wound Infection; Anti-Bacterial Agents

Study Results

Participant Flow

Arm/Group Title	DFA-02 Antibiotic Gel	DFA-02 Placebo Gel	Standard of Care
Arm/Group Description	Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel	Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel	Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Period Title: Overall Study
STARTED	296	71	78
COMPLETED	288	66	73
NOT COMPLETED	8	5	5

Baseline Characteristics

Arm/Group Title	DFA-02 Antibiotic Gel	DFA-02 Placebo Gel	Standard of Care	Total
Arm/Group Description	Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel	Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel	Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.	Total of all reporting groups
Overall Participants	296	71	78	445
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.1 (14.6)	58.8 (15.7)	59.6 (14.7)	59.8 (14.8)
Sex: Female, Male (Count of Participants)
Female	142 48%	33 46.5%	45 57.7%	220 49.4%
Male	154 52%	38 53.5%	33 42.3%	225 50.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.3%	0 0%	0 0%	1 0.2%
Asian	8 2.7%	1 1.4%	0 0%	9 2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	31 10.5%	10 14.1%	4 5.1%	45 10.1%
White	255 86.1%	60 84.5%	74 94.9%	389 87.4%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 0.3%	0 0%	0 0%	1 0.2%
Region of Enrollment (participants) [Number]
United States	296 100%	71 100%	78 100%	445 100%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Surgical Site Infections
Time Frame	Within 30 days of surgery

Outcome Measure Data

Analysis Population Description

The number of SSIs from the day of surgery to 30 days post-op could only be assessed in the 427 completed patients. Central adjudication by the Clinical Events Committee was not able to assess the presence or absence of SSI for two patients, one in the DFA-02 group and one in the SOC group so the total analyzed is only 425.

Arm/Group Title	DFA-02 Antibiotic Gel	DFA-02 Placebo Gel	Standard of Care
Arm/Group Description	Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel	Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel	Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Measure Participants	287	66	72
Number [participants]	42 14.2%	14 19.7%	25 32.1%

2. Secondary Outcome

Title	Number of Patients With Adverse Events
Time Frame	Within 30 days of surgery

Outcome Measure Data

Analysis Population Description

The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the patients who did not receive gel were counted in the SOC group.

Arm/Group Title	DFA-02 Antibiotic Gel	DFA-02 Placebo Gel	Standard of Care
Arm/Group Description	Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel	Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel	Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Measure Participants	284	64	93
Number [participants]	267 90.2%	61 85.9%	86 110.3%

3. Secondary Outcome

Title	Change in Serum Creatinine Measurements From Baseline
Description	Change from baseline in micromoles/liter
Time Frame	Within 4 days of surgery

Outcome Measure Data

Analysis Population Description

402 of the 445 patients had both baseline and post-operative creatinine measurements. Safety analyses were "as treated" so patients randomized to gel but did not receive it in surgery were counted in the SOC group.

Arm/Group Title	DFA-02 Antibiotic Gel	DFA-02 Placebo Gel	Standard of Care
Arm/Group Description	Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel	Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel	Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Measure Participants	262	61	79
Mean (Standard Deviation) [micromoles/liter]	-10.2 (18.2)	-9.9 (12.8)	-10.2 (27.0)

4. Secondary Outcome

Title	Cumulative ASEPSIS Score for Each Patient
Description	Total ASEPSIS score with a range of 0-65 points with lower scores being better. The score is the sum of: Antibiotic Use (10 points), Drainage of Pus Under Local Anesthesia (5 points), Debridement Under General Anesthesia (10 points), Serous Discharge (5 points), Erythema (5 points), Purulent Exudate (5 points), Separation of Deep Tissues (10 points) and Isolation of Bacteria from Discharge (10 points). Source: Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. Lancet. 1986:1(8476):311-3.
Time Frame	Through post-operative Day 4

Outcome Measure Data

Analysis Population Description

Safety analyses were "as treated" so patients who were randomized to gel but did not receive it are counted as SOC. For 4 patients, the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized.

Arm/Group Title	DFA-02 Antibiotic Gel	DFA-02 Placebo Gel	Standard of Care
Arm/Group Description	Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel	Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel	Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Measure Participants	284	64	93
Mean (Standard Deviation) [units on a scale]	17.5 (8.1)	18.5 (3.5)	23.0 (3.5)

Adverse Events

Time Frame	From time of surgery until 30 days post-op.
Adverse Event Reporting Description	Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Arm/Group Title	DFA-02 Antibiotic Gel		DFA-02 Placebo Gel		Standard of Care
Arm/Group Description	Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel		Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel		Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
All Cause Mortality
	DFA-02 Antibiotic Gel		DFA-02 Placebo Gel		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	DFA-02 Antibiotic Gel		DFA-02 Placebo Gel		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	59/284 (20.8%)		14/64 (21.9%)		21/93 (22.6%)
Blood and lymphatic system disorders
Anemia	1/284 (0.4%)	1	0/64 (0%)	0	1/93 (1.1%)	1
Leukocytosis	0/284 (0%)	0	1/64 (1.6%)	1	0/93 (0%)	0
Cardiac disorders
Atrial Fibrillation	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Cardiac Arrest	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Myocardial Infarction	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Ventricular Tachycardia	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Gastrointestinal disorders
Small Intestine Obstruction	4/284 (1.4%)	4	0/64 (0%)	0	1/93 (1.1%)	1
Enterocutaneous Fistula	3/284 (1.1%)	3	0/64 (0%)	0	1/93 (1.1%)	1
Ileus	2/284 (0.7%)	2	1/64 (1.6%)	1	1/93 (1.1%)	1
Gastrointestinal Hemorrhage	2/284 (0.7%)	2	0/64 (0%)	0	1/93 (1.1%)	1
Abdominal Wall Hematoma	1/284 (0.4%)	1	0/64 (0%)	0	1/93 (1.1%)	1
Abdominal Pain	0/284 (0%)	0	1/64 (1.6%)	1	0/93 (0%)	0
Intestinal Obstruction	0/284 (0%)	0	1/64 (1.6%)	1	0/93 (0%)	0
Intra-abdominal Hemorrhage	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Localized Abdominal Fluid Collection	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Nausea	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Pneumoperitoneum	0/284 (0%)	0	0/64 (0%)	0	1/93 (1.1%)	1
Rectal Hemorrhage	0/284 (0%)	0	0/64 (0%)	0	1/93 (1.1%)	1
Small Intestinal Perforation	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
General disorders
Asthenia	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Device Dislocation	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Systemic Inflammatory Response Syndrome	0/284 (0%)	0	0/64 (0%)	0	1/93 (1.1%)	1
Infections and infestations
Pelvic Abscess	1/284 (0.4%)	1	4/64 (6.3%)	4	0/93 (0%)	0
Pneuomia	3/284 (1.1%)	3	1/64 (1.6%)	1	1/93 (1.1%)	1
Abdominal Abscess	1/284 (0.4%)	1	0/64 (0%)	0	3/93 (3.2%)	3
Abscess	2/284 (0.7%)	2	0/64 (0%)	0	0/93 (0%)	0
Peritonitis	2/284 (0.7%)	2	0/64 (0%)	0	0/93 (0%)	0
Wound Infection	0/284 (0%)	0	1/64 (1.6%)	1	1/93 (1.1%)	1
Abdominal Infection	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Abdominal Sepsis	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Clostridium difficile Infection	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Hematoma Infection	0/284 (0%)	0	0/64 (0%)	0	1/93 (1.1%)	1
Incision Site Infection	0/284 (0%)	0	0/64 (0%)	0	1/93 (1.1%)	1
Postoperative Wound Infection	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Sepsis	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Septic Shock	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Splenic Abscess	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Subdiaphragmatic Abscess	0/284 (0%)	0	1/64 (1.6%)	1	0/93 (0%)	0
Urinary Tract Infection	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Injury, poisoning and procedural complications
Postoperative Ileus	7/284 (2.5%)	7	2/64 (3.1%)	2	4/93 (4.3%)	4
Anastomotic Leak	2/284 (0.7%)	2	1/64 (1.6%)	1	1/93 (1.1%)	1
Abdominal Wound Dehiscence	0/284 (0%)	0	0/64 (0%)	0	1/93 (1.1%)	1
Anastomotic Complication	0/284 (0%)	0	0/64 (0%)	0	1/93 (1.1%)	1
Bladder Injury	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Hip Fracture	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Postoperative Renal Failure	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Procedural Vomiting	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Splenic Rupture	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Wound Secretion	0/284 (0%)	0	1/64 (1.6%)	1	0/93 (0%)	0
Metabolism and nutrition disorders
Dehydration	6/284 (2.1%)	6	0/64 (0%)	0	1/93 (1.1%)	1
Failure to Thrive	0/284 (0%)	0	0/64 (0%)	0	1/93 (1.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer Metastatic	0/284 (0%)	0	0/64 (0%)	0	1/93 (1.1%)	1
Renal Cell Carcinoma	0/284 (0%)	0	0/64 (0%)	0	1/93 (1.1%)	1
Psychiatric disorders
Mental Status Changes	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Renal and urinary disorders
Acute Kidney Injury	1/284 (0.4%)	1	0/64 (0%)	0	2/93 (2.2%)	2
Reproductive system and breast disorders
Pelvic Pain	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure	3/284 (1.1%)	3	0/64 (0%)	0	1/93 (1.1%)	1
Pulmonary Embolism	3/284 (1.1%)	3	1/64 (1.6%)	1	0/93 (0%)	0
Respiratory Failure	3/284 (1.1%)	3	0/64 (0%)	0	0/93 (0%)	0
Chronic Obstructive Pulmonary Disease	1/284 (0.4%)	1	0/64 (0%)	0	0/93 (0%)	0
Pneumonia Aspiration	0/284 (0%)	0	0/64 (0%)	0	1/93 (1.1%)	1
Other (Not Including Serious) Adverse Events
	DFA-02 Antibiotic Gel		DFA-02 Placebo Gel		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	267/284 (94%)		61/64 (95.3%)		86/93 (92.5%)
Blood and lymphatic system disorders
Leukocytosis	29/284 (10.2%)	29	6/64 (9.4%)	6	12/93 (12.9%)	12
Anemia	24/284 (8.5%)	24	4/64 (6.3%)	4	10/93 (10.8%)	10
Cardiac disorders
Tachycardia	46/284 (16.2%)	46	14/64 (21.9%)	14	15/93 (16.1%)	15
Gastrointestinal disorders
Nausea	118/284 (41.5%)	118	32/64 (50%)	32	41/93 (44.1%)	41
Vomiting	39/284 (13.7%)	39	15/64 (23.4%)	15	11/93 (11.8%)	11
Diarrhea	25/284 (8.8%)	25	1/64 (1.6%)	1	3/93 (3.2%)	3
Dyspepsia	17/284 (6%)	17	4/64 (6.3%)	4	2/93 (2.2%)	2
Constipation	14/284 (4.9%)	14	4/64 (6.3%)	4	1/93 (1.1%)	1
Abdominal Distention	10/284 (3.5%)	10	3/64 (4.7%)	3	5/93 (5.4%)	5
General disorders
Pyrexia	30/284 (10.6%)	30	6/64 (9.4%)	6	7/93 (7.5%)	7
Infections and infestations
Incision Site Infection	17/284 (6%)	17	3/64 (4.7%)	3	4/93 (4.3%)	4
Pelvic Abscess	2/284 (0.7%)	2	4/64 (6.3%)	4	0/93 (0%)	0
Injury, poisoning and procedural complications
Procedural Pain	143/284 (50.4%)	143	32/64 (50%)	32	52/93 (55.9%)	52
Procedural Nausea	28/284 (9.9%)	28	8/64 (12.5%)	8	10/93 (10.8%)	10
Anemia Postoperative	26/284 (9.2%)	26	6/64 (9.4%)	6	12/93 (12.9%)	12
Incision Site Pain	17/284 (6%)	17	3/64 (4.7%)	3	3/93 (3.2%)	3
Postoperative Ileus	12/284 (4.2%)	12	3/64 (4.7%)	3	4/93 (4.3%)	4
Seroma	12/284 (4.2%)	12	5/64 (7.8%)	5	0/93 (0%)	0
Investigations
Urine Output Decreased	26/284 (9.2%)	26	5/64 (7.8%)	5	10/93 (10.8%)	10
Oxygen Saturation Decreased	16/284 (5.6%)	16	3/64 (4.7%)	3	6/93 (6.5%)	6
Amylase Decreased	3/284 (1.1%)	3	0/64 (0%)	0	5/93 (5.4%)	5
Metabolism and nutrition disorders
Hyperglycemia	46/284 (16.2%)	46	8/64 (12.5%)	8	18/93 (19.4%)	18
Hypokalemia	43/284 (15.1%)	43	7/64 (10.9%)	7	17/93 (18.3%)	17
Hypophosphatemia	39/284 (13.7%)	39	9/64 (14.1%)	9	14/93 (15.1%)	14
Hypocalcemia	37/284 (13%)	37	7/64 (10.9%)	7	15/93 (16.1%)	15
Hypomagnesemia	25/284 (8.8%)	25	5/64 (7.8%)	5	12/93 (12.9%)	12
Hypoproteinemia	26/284 (9.2%)	26	4/64 (6.3%)	4	10/93 (10.8%)	10
Hypoalbuminemia	28/284 (9.9%)	28	2/64 (3.1%)	2	8/93 (8.6%)	8
Hyponatremia	19/284 (6.7%)	19	4/64 (6.3%)	4	8/93 (8.6%)	8
Hypochloremia	14/284 (4.9%)	14	1/64 (1.6%)	1	5/93 (5.4%)	5
Nervous system disorders
Headache	17/284 (6%)	17	3/64 (4.7%)	3	5/93 (5.4%)	5
Psychiatric disorders
Anxiety	19/284 (6.7%)	19	2/64 (3.1%)	2	7/93 (7.5%)	7
Insomnia	15/284 (5.3%)	15	2/64 (3.1%)	2	9/93 (9.7%)	9
Renal and urinary disorders
Hematuria	12/284 (4.2%)	12	8/64 (12.5%)	8	8/93 (8.6%)	8
Urinary Retention	14/284 (4.9%)	14	4/64 (6.3%)	4	9/93 (9.7%)	9
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain	28/284 (9.9%)	28	7/64 (10.9%)	7	3/93 (3.2%)	3
Skin and subcutaneous tissue disorders
Pruritus	42/284 (14.8%)	42	9/64 (14.1%)	9	15/93 (16.1%)	15
Vascular disorders
Hypertension	34/284 (12%)	34	7/64 (10.9%)	7	6/93 (6.5%)	6
Hypotension	23/284 (8.1%)	23	2/64 (3.1%)	2	9/93 (9.7%)	9

Limitations/Caveats

The number of culture positive SSIs were too small to draw any conclusions on antibiotic resistance.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.