Study to compare efficacy and safety of trypsion plus bromelain plus rutoside tablet along with cefuroxime axetil tablet versus cefuroxime axetil tablet given alone in patients with surgical wound after minor surgery
- Conditions
- Local infection of the skin and subcutaneous tissue, unspecified,
- Registration Number
- CTRI/2020/08/027070
- Lead Sponsor
- Lokmanya Medical Research Center
- Brief Summary
A Prospective, Single-center, Open label, Randomized, Parallel-group, Active-controlled Clinical
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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
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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
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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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 50
-
- 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 page 2 / 6 REF/2020/06/034654 CTRI Website URL.
- http://ctri.nic.in 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.
- 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.
- Female patients who are pregnant or lactating or planning to be pregnant.
- Patients with known history of clostridium difficile-associated diarrhea.
- Patients receiving medicines such as tetracycline group of drugs, amoxicillin, aspirin, and anticoagulants including clopidogrel.
- Currently receiving treatment with IP or systemic or topical antibiotics or systemic therapy with cytotoxic drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with improvement in 11 Days surgical wound after minor surgery 11 Days
- Secondary Outcome Measures
Name Time Method Proportion of patients with improvement in surgical wound after minor surgery Number/percentage of patients with complete wound regeneration
Trial Locations
- Locations (1)
Lokmanya Medical Research Center
🇮🇳(Suburban), MAHARASHTRA, India
Lokmanya Medical Research Center🇮🇳(Suburban), MAHARASHTRA, IndiaDr Sachin Onkar KhalanePrincipal investigator9158071773khalanesachin@gmail.com