Health Condition 1: T814- Infection following a procedure
Conditions
Interventions
Intervention1: Theruptor Surgical Wound Dressing: Theruptor consists of a 3-D Knitted Hydrocellular textile substrate made of PET and PU that
allows for superior exudate management through wicking whi
Sponsors
CareNow Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female of age 18 years or older. 2. Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study. 3. Patients undergoing elective abdominal surgery/elective c-section surgery/elective Joint surgery
Exclusion criteria
Exclusion criteria: 1. Patients with severe anemia - Hgb 2. Patients with severe malnutrition (Albumin 10% weight loss in preceding 4 weeks) 3. Patients with serum Creatinine more than 2 mg/dl 4. HbA1c more than 10% Patients with primary peritonitis and liver cirrhosis. 5.Patient who are taking medications that are considered immune system modulator. 6.Wounds in which incision edges are under high tension or not easily apposed (after deep layer suture).Wounds in which deep closure could not be achieved 7. Allergy to the test or comparator products employed in the study. 8. Wounds in which hemostasis is not able to be achieved, eg, drain is placed or Warfarin PT- INR level >2.5 prior to surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The proportion of completely healed wounds in patients treated with Theruptor Surgical Wound Dressing versus comparator Tegaderm dressing and plain gauze dressing and the mean time to complete wound closure/healing is calculated 2. Surgical Site infection rate will be assessed during each dressing change by performing Microbiological assessment of wound with swab test. Timepoint: Day 3,7,10,14 and 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complications after surgery 2. Microbiological assessment of sample dressing material (50 nos.) will be done from randomly selected patients. 3. Evaluation of systemic lab parameters (blood analysis), which contributes for wound healing. 4. Cardiff Wound Impact Questionnaire and Overall Quality of life will be assessed.Timepoint: Day 3,7,10,14 and 28;1. Percentage of wound dehiscence will be assessed. 2. Wound pain assessment, using standardized Visual Analog Scale. 3. Clinical Assessment of wounds that include purulent drainage, haemorrhage, swelling, erythema and Scab (graded as none, scant, moderate and copious) 4. Cosmetic assessment (width, height and color of the scar, presence of suture marks and overall appearance) will be done at day 10, 14 and day 8 using Stony Brook Scar evaluation scale.Timepoint: Day 3,7,10,14 and 28;Analysis of product performance parameters in Percentage. like 1. Dressing easy to apply, 2. Dressing easy to remove, 3.Comfortable to wear ,Good/acceptable dressing Conformability- On application , 4. No discolouration to surrounding skin/Slight discolouration to surrounding skin, 5.No pain on dressing application, 6. No pain on dressing removal, 7. Satisfied with exudate and leakage handling of dressing, 8. Number of Dressing changes required, 9. Mean Wear time of dressing(overall patients) with range 10. Mobility of the patients . ? To compare cosmetic outcomes at end of 4 weeks. Cosmesis to be evaluated by a panel of masked evaluators using a modified Hollander Wound Evaluation Scale.Timepoint: Day 3,7,10,14 and 28 | — |
Countries
India
Contacts
Public ContactDr Uma Narayanamurthy
AIIMS, Jodhpur
Outcome results
None listed