A Prospective, Single-center, Open label, Randomized, Parallel-group, Active-controlled Clinical

page 3 / 6

REF/2020/06/034654

CTRI Website URL - http://ctri.nic.in

Study to Evaluate the Efficacy and Safety of FDC of Trypsin + Bromelain + Rutoside trihydrate

given along with Cefuroxime axetil versus Cefuroxime axetil for Healing in Patients with Surgical

Wound after Minor Surgery

A surgical wound is an incision cause minimal tissue damage. They are made with precision in an

environment where aseptic and antiseptic techniques reduce the risk of infection; with the best of

instruments and the facility to control haemostasis.Surgical incisions are inseparable procedures in

most of the surgery. These surgical incisions cause disruption of the normal structure and function

of the skin and its architecture to form a wound. It takes few to several weeks for complete healing

of wound in most of the cases as it passes through highly programmed phases which are

hemostasis, inflammation, proliferation and remodeling. However, few wounds are either very slow

or fail to heal due to infection by pathogenic organisms. Moreover, some endogenous factors like

dead tissue, poor perfusion and local inflammatory reactions also play a vital role in the process of

wound healing. Pathologically, there is a release of chemotactic growth factors, cytokines and other

mediators which induce recruitment of polymorphonucleocytes and monocytes.

polymorphonucleocytes act by removing unwanted materials such as bacteria and devitalized

tissues. Simultaneously, metalloproteinases like gelatinase, collagenase and stromelysin play a

crucial role by degrading damaged extra cellular matrix component such as collagen, elastin and

proteoglycans. The next step is removal of micro-organism and tissue debris by phagocytosis. At

last, there is a release of growth factor for tissue repair.

STUDY OBJECTIVES

Primary Objective

To evaluate the improvement in the surgical wound after minor surgery as assessed by each

parameter of Bates-Jensen Wound Assessment (BWAT) score on Day 11

Secondary Objectives

• To evaluate the improvement in the surgical wound after minor surgery as assessed by each

parameter of BWAT score on Day 5

• To evaluate the number/percentage of patients with complete wound regeneration on Day 5 and

Day 10

Safety Objective

• Safety and tolerability of the investigational product (IP)

STUDY DESIGN

page 4 / 6

REF/2020/06/034654

CTRI Website URL - http://ctri.nic.in

Overview of the Study Design This is a prospective, single-center, open label, randomized,

parallel-group, active-controlled clinical study to evaluate the efficacy and safety of FDC of Trypsin

+ Bromelain + Rutoside trihydrate given along with Cefuroxime axetil versus Cefuroxime axetil for

healing in patients with surgical wound after minor surgery There are 5 scheduled study site visits

during the entire study period; Visit 1 (Screening period/Up to 2 days), Visit 2 (Randomization/Start

of study treatment with IP), Visit 3 (Treatment period/Day 5 (±2 days), Visit 4 (End of treatment

[EOT]/Day 11 (±2 days) and End of study (EOS)/Telephonic safety follow-up after 7 days of last

dose of IP, Individual participation of the patient in the study will last for up to 15 days. Patients will

undergo screening study procedures and assessments upon signing of informed consent form

(ICF). Detailed medical/surgical, prior and concomitant medication details will be asked from

patients and recorded. Upon screening assessments and procedures, a total of 50 eligible patients

will be randomized in 1:1ratio to receive treatment from any one study treatment groups:

• Group A: FDC of Trypsin + Bromelain + Rutoside Trihydrate along with Cefuroxime axetil

• Group B: Cefuroxime axetil

Day 1 of study treatment will be when the patient consumes first dose of study treatment. All

subsequent visits will be scheduled based on Day 1.

Day 11 of study treatment will be the EOT day in the study. The primary and secondary efficacy

endpoints assessment will be assessed on this day.

EOS/telephonic safety follow-up will be performed after 7 days of last dose of IP.

Unscheduled study visits

Patients requiring additional clinical study site visit based on any safety concern or any other urgent

requirement can be called to the clinical study site. Such visits during the study period will be

termed as unscheduled visits. An Unscheduled visit number will be given and details will be

recorded on unscheduled case report form (CRF) page. Investigator may conduct procedures or

assessments without compromising on patient’s safety and as per the requirement of the

unscheduled visit.

PATIENT ELIGIBILITY

Inclusion criteria

page 5 / 6

REF/2020/06/034654

CTRI Website URL - http://ctri.nic.in

1. Adult male or female patients aged between 18 to 65 years of age (both ages inclusive)

2. Diagnosed with surgical wounds after minor surgery mainly involving skin and skin structure

infections

3. Women of childbearing potential must be willing to consistently use an appropriate method of

contraception

4. Willingness to give their written informed consent to participate in the study

5. Is willing to comply with all aspects of the protocol

Exclusion criteria

1. Patients with known hypersensitivity to active ingredients or inactive ingredients of the study

treatment or other ?-lactams (e.g., penicillins and cephalosporins) except study treatment.

2. Female patients who are pregnant or lactating or planning to be pregnant.

3. Patients with known history of clostridium difficile-associated diarrhea.

4. Patients receiving medicines such as tetracycline group of drugs, amoxicillin, aspirin, and

anticoagulants including clopidogrel.

5. Currently receiving treatment with IP or systemic or topical antibiotics or systemic therapy with

cytotoxic drugs.

6. Evidence or history of clinically significant medical or surgical abnormality including clinically

significant laboratory parameters that, in the opinion of the investigator, would put the patient at risk

through study period, or would affect the study analyses if the disease exacerbates during the

study.

7. History of drug/substance abuse

8. Poor general condition, which in the opinion of the Investigator makes the patient ineligible to

participate in the study

9. Patients with uncontrolled diabetes mellitus or any other metabolic disorder

10. Patient with history of hepatic and/or renal disorder, bleeding disorders, menorrhagia, hematuria

and hematemesis.

11. Patients who are currently enrolled in another clinical study or have been enrolled in any

surgical wound research study within a 30 days prior to screening.

12. Any other condition that, in the opinion of the investigator, does not justify the inclusion of the

patient in the study.