Health Condition 1: null- Bedsore
Conditions
Interventions
Intervention1: Negative Pressure Device (NPD): Negative Pressure wound therapy by negative pressure device (NPD)is a vacuum assisted method for wound care that imparts a negative pressure of -60 to -1
Sponsors
Council of Science Technology
Dr Amita Jain
Dr Rajiv Agarwal
Eligibility
Inclusion criteria
Inclusion criteria: 1.Sacral pressure sores in traumatic paraplegia patients with no signs of improvement and healing. 2. Stage III-IV pressure ulcer according to the National Pressure Ulcer Advisory Panel (NPUAP) 3. No clinical signs of active infection at the wound site and currently not on antibiotics. 4. Patients to give informed consent.
Exclusion criteria
Exclusion criteria: 1.Candidate for surgery. 2. A wound with necrotic tissue unable to tolerate debridement. 3. Exposed blood vessels within the wound. 4. Chronic osteomyelitis (as determined by biopsy) or osteomyelitis that is not treatable by debridement and antibiotics. 5. Non-enteric or unexplored fistulae. 6. Wounds requiring homeostasis (i.e., that the flow of blood be stopped) for local bleeding. 7. Alternate etiology for non-healing. 8. Concomitant conditions that in the judgment of the investigator would make the subject inappropriate for entry to the study (e.g., malignancy in wound, malignancy less than 1-year disease free interval, previous or current irradiation, known immunodeficiency and/or major uncorrected medical disorders such as serious non-malignant disease, serious cardiovascular or pulmonary disease, lupus, inflammatory bowel disease, palliative care or sickle cell disease) 9. Poor nutritional status as determined by a Braden Scale Nutritional Assessment score of 2 or 1 with a serum albumin 10. Currently taking medication that may interfere with wound healing (e.g., oral systemic steroids, immunosuppressive drugs, unfractionated heparin infusion) 11. Women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time taken in healing (primary endpoint was a granulated wound or a wound ready for skin grafting or healing by secondary intention) 2. Rate of reduction of wound surface area and wound depth 3. Reduction in wound volume 4. Time of becoming culture negative. 5. Changes in levels of marker (MMP8). Timepoint: 3 Years | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety efficacy and cost effectiveness.Timepoint: 3 Years | — |
Countries
India
Contacts
Public ContactAmit Kumar Bhagat
King Georgeâ??s Medical University, Lucknow
Outcome results
None listed