The Impact of Interventional Enzymes on Post-Operative Wound Healing - A Double-Blinded Randomized Clinical Trial.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 65
- Locations
- 2
- Primary Endpoint
- 1.Changes in inflammation score (edema) on VRS
Study Overview
Brief Summary
Surgical wounds, especially in co-morbid conditions, pose significant challenges in management. The growing use of multiple medications in healthcare highlights their relevance, yet applying them effectively in surgical wound care is comparable to "separating diamonds from the ore." Despite efforts to unravel wound molecular intricacies and explore the impact of various molecules, a definitive, evidence-based therapy for wounds remains elusive. The recent pandemic has exacerbated healthcare challenges due to limited access to facilities. In addressing clinical challenges, a clear understanding of protease enzymes is essential, offering clinicians better options for selecting appropriate drug regimens.
Thus, the aim of the study was to compare the short-term efficacy and tolerability of an oral enzyme supplement (EnMax) with the placebo and similar market product post –operative patients. The present trial was undertaken to ascertain whether oral proteolytic enzymes would act systemically to exert an anti-edema effect, thereby encouraging more rapid wound healing following surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 25.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with 25-50 years of age (both inclusive);
- •Patients electively posted for clean surgery (Dental surgery, Orthopaedic surgery, Cosmetic Surgery, Laparoscopic, etc.) will be included in the study;
- •Patient without any suspected or confirmed infection and receiving treatment for same;
- •Willing to give informed consent for the study.
Exclusion Criteria
- •Allergy, sensitivity, or contraindication to any interventional product;
- •Patients undergoing emergency, clean – contaminated, contaminated and dirty surgical procedure cases;
- •History of gastric ulcer or bleeding diathesis;
- •Currently receiving cytotoxic therapy, or have received it within the last three months;
- •Patients treated with any investigational drug in the preceding 4 weeks;
- •Female patients with a positive pregnancy test or lactating;
- •Patients with uncontrolled diabetes mellitus or any other metabolic disorder;
- •Seriously ill and moribund patients with complications;
- •Patients unable to comply with the treatment regimen;
- •Patients with any other condition that, in the opinion of the investigator, does not justify the inclusion of the patient in the study.
Outcomes
Primary Outcomes
1.Changes in inflammation score (edema) on VRS
Time Frame: At day 1, 2, 5, and 7.
2.Changes in pain score on VAS
Time Frame: At day 1, 2, 5, and 7.
Secondary Outcomes
- The impact of investigational products on inflammatory biomarkers (ESR and CRP), analgesic requirement, and overall improvement in post-operative wound healing.(Safety of the interventions will be assessed by analyzing changes laboratory investigations, monitoring the adverse events profile and evaluating the compliance and tolerability of the investigational product throughout the study.)
Investigators
Dr V G Vaidya
Lokmanya Medical Research Centre