Surgical Site InfectionPhase 1/2NCT01496352

DFA-02 in Patients Undergoing Colorectal Surgery

A Phase 1/2 study testing DFA-02 in people with Surgical Site Infection, run by Dr. Reddy's Laboratories Limited at 5 sites in United States.

Completed

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

Official record

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Trial summary

This is a randomized, double-blind, placebo controlled, safety, tolerability, and pharmacokinetic dose escalation Phase II study of DFA-02 in patients undergoing colorectal surgery to evaluate the safety, tolerability and pharmacokinetics of DFA-02. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Surgical Site Infection
What is being tested?: DFA-02
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 5 sitesUnited States
Study dates: Feb 2012to Jun 2013
Phase: Phase 1/2
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

Males and females 18 years of age or older;
If female, the patient must be:
postmenopausal (if amenorrheic for < 1 year, postmenopausal status must be confirmed by an elevated follicle stimulating hormone [FSH] level > 30 mIU/mL; if amenorrheic for > 1 year, FSH level not required);
surgically sterilized (does not have a uterus or has had bilateral tubal ligation); or
if of child-bearing potential, she must have a negative serum pregnancy test on entry in the study, and agree to use adequate birth control during the study and for 30 days after the administration of study agent. Medically acceptable contraceptives include: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD);
BMI 25-40, inclusive;

Show all 9Show fewer

Scheduled to undergo nonemergent colorectal surgery involving a laparotomy incision of 7 cm or greater (hand-assisted laparoscopic surgery is allowed). List of eligible procedures: left, right or transverse colectomy, segmental/sleeve left colon resection, total abdominal colectomy with ileorectal anastomosis, total abdominal colectomy with ileostomy, total abdominal proctocolectomy, 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;
Willing and able to give informed consent;
Available for evaluation from baseline until final evaluation at 30 days post surgery.

Who cannot join

Known history of hypersensitivity to gentamicin or vancomycin, other aminoglycoside antibiotics or the excipients of the study products (soy bean products or sesame oil);
Emergency surgery (urgent surgery is allowed if informed consent is obtained and the study procedures can be performed);
Significant concomitant surgical procedure (Note: concomitant appendectomy, cholecystectomy, oophorectomy, and liver biopsy/wedge resection are allowed);
Prior laparotomy within the last 60 days of this planned procedure;
Planned second laparotomy or colorectal surgical procedure (e.g. colostomy or ileostomy takedown) within 30 days of this planned first procedure;
Expectation that a surgical drain will be placed;

Show all 27Show fewer

Preoperative sepsis, severe sepsis, or septic shock;
Abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason;
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 (Note: single dose antibiotic therapy for dental or other minor procedures is allowed as is the use of oral non-absorbable antibiotics for preoperative bowel decontamination);
Requirement for gentamicin or vancomycin preoperative antimicrobial prophylaxis (Note: systemic antibiotic therapy within 72 hours after surgery with gentamicin or vancomycin must be avoided and any systemic antibiotic therapy during that time should be discussed with the Coordinating Center PI or Medical Monitor);
Requirement for concomitant use or use during the 30 days prior to Day 1 of any prescription or OTC drug that would interfere with the study or place the patient at undue risk. Concurrent systemic or topical use of other potentially neurotoxic, nephrotoxic, and/or ototoxic drugs, such as gentamicin, cisplatin, cephaloridine, kanamycin, amikacin, polymyxin B, colistin, paromomycin, streptomycin, tobramycin, vancomycin, ethacrynic acid, furosemide, and viomycin, should be avoided;
Preoperative evaluation suggests an intra-abdominal process that might preclude full closure of the skin;
Ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer;
History of significant drug or alcohol abuse within the past year;
Serum Creatinine > 1.3 mg/dL
Serum Bilirubin > 2.5 times upper limit of normal;
History of uncontrolled diabetes mellitus (controlled diabetic patients whose hemoglobin A1c is ≤ 9.0% may be included);
Patients 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 (Note: inhaled corticosteroids are not exclusionary and single dose use of corticosteroids to prevent PONV is allowed.);
Any clinically meaningful hearing loss (from Medical History);
Clinically exclusionary results on clinical laboratory, ECG, or physical examination including but not limited to positive hepatitis B or C or HIV;
Pregnant or lactating, or if of childbearing potential not practicing a birth control method with a high degree of reliability;
Refusal to accept medically indicated blood products;
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;
Patients with anterior abdominal wall mesh that is not planned to be completely removed during the planned procedure;
Unable to participate in the study for any reason in the opinion of the Principal Investigator;
Postsurgical life expectancy of less than 30 days, in the Investigator's or Sponsor's opinion;
Expected discharge from the hospital less than 3 days after surgery.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Study site
Bellaire, Texas
Study site
Columbus, Ohio
Study site
Florence, Alabama
Study site
Tampa, Florida
Study site
Temple, Texas

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo Controlled, Safety, Tolerability, and Pharmacokinetic Dose Escalation Study of DFA-02 in Patients Undergoing Colorectal Surgery

Read the detailed description

Despite antibiotic prophylaxis and improvements in surgical techniques, surgical site infections (SSI) still occur. DFA-02 is a novel bioresorbable modified release gel containing both gentamicin and vancomycin to be applied during surgical incision closure for the prevention of surgical site infections (SSIs) in patients undergoing colorectal surgery.

Conditions: Surgical Site Infection
Being tested: DFA-02, Placebo
Keywords: Surgical site infection, 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.

DFA-02Drug
Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure
PlaceboDrug
DFA-02 placebo

Study groups in NCT01496352
Study group	Role	What they receive
DFA-02	Experimental	Progressive cohorts of 10 subjects (8 active, 2 placebo) receiving 10, 20 , 30 or 40 mL of DFA-02 or matching placebo. Receives: Drug: DFA-02
DFA-02 placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Number of Patients With Adverse Events, Laboratory, Physical Examination Changes
Safety and tolerability measured by number of patients with adverse events or changes in laboratory or physical examination findings from baseline (DFA-02 application during surgery on Day 1) to 30 days after surgery.
Measured: Baseline up to Day 30
Area Under Curve (AUC)
Area under the curve (AUC) of plasma gentamicin and vancomycin levels using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery
Measured: 1, 6, 24, 48 96 hours post-dose

Secondary outcomes (4)

Maximal Plasma Concentration (Cmax)
Maximal plasma concentration (Cmax)of gentamicin and vancomycin using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery
Measured: 1, 6, 24, 48, 96 hours post-dose
Renal Function
Changes in serum creatinine from surgery on Day 1 until 14 days after surgery
Measured: Baseline up to Day 14
Antibiotic Resistance
Methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococcus presence at surgery on Day 1 and 5 days after surgery
Measured: Baseline up to Day 5
Incidence of Surgical Site Infection
The incidence of probable or definite surgical site infection as determined by the Investigator.
Measured: Up to 30 Days After Surgery

Timeline

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

Feb 2012Jun 2013

First posted21 Dec 2011 (estimated)
Study startFeb 2012
Primary completionApr 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01496352
Sponsor's protocol ID: DFA-02-CD-002
Status last verified: Aug 2014
First submitted: 15 Dec 2011
Last updated: 1 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Bennett-Guerrero E, Minkowitz HS, Segura-Vasi AM, Marcet JE, White JA, Corey GR, Allenby KS. A randomized, double-blind, placebo controlled safety, tolerability, and pharmacokinetic dose escalation study of a gentamicin vancomycin gel in patients undergoing colorectal surgery. Perioper Med (Lond). 2016 Jun 16;5:17. doi: 10.1186/s13741-016-0043-2. eCollection 2016.
PubMed 27313846

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Surgical Site Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo Controlled, Safety, Tolerability, and Pharmacokinetic Dose Escalation Study of DFA-02 in Patients Undergoing Colorectal Surgery
ClinicalTrials.gov ID: NCT01496352
Acronym / sponsor ID: DFA-02-CD-002
Conditions: Surgical Site Infection
Keywords: Surgical site infection, Colorectal surgery
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
Collaborators: Duke Clinical Research Institute
Study start: Feb 2012
Primary completion: Apr 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 21 Dec 2011 (estimated)
Results: Posted 1 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
DFA-02	Experimental	Drug: DFA-02Progressive cohorts of 10 subjects (8 active, 2 placebo) receiving 10, 20 , 30 or 40 mL of DFA-02 or matching placebo.
DFA-02 placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Males and females 18 years of age or older;
If female, the patient must be:
BMI 25-40, inclusive;
Scheduled to undergo nonemergent colorectal surgery involving a laparotomy incision of 7 cm or greater (hand-assisted laparoscopic surgery is allowed). List of eligible procedures: left, right or transverse colectomy, segmental/sleeve left colon resection, total abdominal colectomy with ileorectal anastomosis, total abdominal colectomy with ileostomy, total abdominal proctocolectomy, 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;
Willing and able to give informed consent;

Key exclusion criteria (27 listed)

Known history of hypersensitivity to gentamicin or vancomycin, other aminoglycoside antibiotics or the excipients of the study products (soy bean products or sesame oil);
Emergency surgery (urgent surgery is allowed if informed consent is obtained and the study procedures can be performed);
Significant concomitant surgical procedure (Note: concomitant appendectomy, cholecystectomy, oophorectomy, and liver biopsy/wedge resection are allowed);
Prior laparotomy within the last 60 days of this planned procedure;
Planned second laparotomy or colorectal surgical procedure (e.g. colostomy or ileostomy takedown) within 30 days of this planned first procedure;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DFA-02Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure	Drug	DFA-02
PlaceboDFA-02 placebo	Drug	DFA-02 placebo

Primary outcome

Number of Patients With Adverse Events, Laboratory, Physical Examination Changes
Time frame: Baseline up to Day 30
Safety and tolerability measured by number of patients with adverse events or changes in laboratory or physical examination findings from baseline (DFA-02 application during surgery on Day 1) to 30 days after surgery.
Area Under Curve (AUC)
Time frame: 1, 6, 24, 48 96 hours post-dose
Area under the curve (AUC) of plasma gentamicin and vancomycin levels using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery

4 secondary outcomes

Maximal Plasma Concentration (Cmax)
Time frame: 1, 6, 24, 48, 96 hours post-dose
Renal Function
Time frame: Baseline up to Day 14
Antibiotic Resistance
Time frame: Baseline up to Day 5
Incidence of Surgical Site Infection
Time frame: Up to 30 Days After Surgery

Results and safety

Results posted to the registry on 1 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DFA-02	24	24
DFA-02 Placebo	6	6

Primary outcome: Number of Patients With Adverse Events, Laboratory, Physical Examination Changes

Time frame: Baseline up to Day 30. Number. Unit: Participants

Measure	DFA-02 n = 24	DFA-02 Placebo n = 6
Any Adverse Event	23	6
Any Serious Adverse Event	5	2
Related Adverse Event	3	0
Death	0	1

Population analysed: As Treated

Primary outcome: Area Under Curve (AUC)

Time frame: 1, 6, 24, 48 96 hours post-dose. Mean (Standard Deviation). Unit: mcg/h/mL

Measure	DFA-02 n = 24	DFA-02 Placebo n = 0
Gentamicin AUC (0-t)	14.2 (12.6)	–
Vancomycin AUC (0-t)	6.47 (8.12)	–

Population analysed: All Subjects Receiving Active Drug

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Informed Consent to 30 Days After Surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DFA-02	5 of 24 (20.8%)	23 of 24 (95.8%)	Not reported
DFA-02 Placebo	2 of 6 (33.3%)	6 of 6 (100%)	Not reported

Limitations and caveats (from the sponsor): Protocol specified cohorts of 10, 20, 30 or 40 mL to be placed after closure of the fascia and prior to skin closure. Experience with 20 and 30 mL dose levels showed that even largest patients would not accommodate 40 mL so that arm was not done.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27313846Bennett-Guerrero E, Minkowitz HS, Segura-Vasi AM, Marcet JE, White JA, Corey GR, Allenby KS. A randomized, double-blind, placebo controlled safety, tolerability, and pharmacokinetic dose escalation study of a gentamicin vancomycin gel in patients undergoing colorectal surgery. Perioper Med (Lond). 2016 Jun 16;5:17. doi: 10.1186/s13741-016-0043-2. eCollection 2016.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kent Allenby, MD study director

Dr. Reddy's Laboratories

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing DFA-02 in people with Surgical Site Infection, run by Dr. Reddy's Laboratories Limited at 5 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 9 inclusion and 27 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 1 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 1 Sep 2014). 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 Patients With Adverse Events, Laboratory, Physical Examination Changes (time frame: Baseline up to Day 30). The study lists 2 primary outcomes in all. 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 NCT01496352, 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 1 Sep 2014; AzTrials last refreshed its copy on 31 Oct 2026.