Comparative study of negative pressure wound therapy versus conventional dressing for the management of traumatic wound
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 1)Changes in wound size
Study Overview
Brief Summary
the study of Comparative study of negative pressure wound therapy versus conventional dressing for the management of traumatic woundgoing to be conducted in trauma centre in IMS,BHU in which 100 patients will be recruited ,50 in each limb.Patients in Each group will be allocated by computer generated random allocation and each group will be assessed on every 5th day for the comparision. Comparision will be done on following points1) change in wound size. 2) percentage of the granulation tissue formed 3) change in the bacterial colony count.
End point of the study is to prepare the wound bed for either split thickness skin grafting or by primary closure.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
Eligibility Criteria
- Ages
- 10.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •patients giving consent for negative pressure therapy 2) clinically stable patients with traumatic wounds irrespective of mode or mechanism of trauma 3) patients of 10-70 years of age and either sex.
Exclusion Criteria
- •refusal of consent 2) traumatic wounds with unmanaged underlying bony fracture 3) wounds with untreated underlying osteomyelitis 4) wounds with fistulas to organs or body cavity 5) severe anemia 6) wounds with associated malignancy 7) dry gangrene 8) patients with chronic conditions like:- a) uncontrolled diabetes mellitus b) peripheral vascular disease c) chronic venous insufficiency.
Outcomes
Primary Outcomes
1)Changes in wound size
Time Frame: Every 5 days
2)change in percentage of granulation tissue
Time Frame: Every 5 days
3)change in bacteria colony count
Time Frame: Every 5 days
Secondary Outcomes
- 1) changes in blood counts(1 yr)