Study to compare negative pressure wound therapy with classical on traumatic wounds

Phase 1/2

Recruiting

• Conditions: Open wound of lower leg, (2) ICD-10 Condition: S518||Open wound of forearm, (3) ICD-10 Condition: S411||Open wound of upper arm, (4) ICD-10 Condition: S711||Open wound of thigh, (5) ICD-10 Condition: S913||Open wound of foot,

• Registration Number: CTRI/2020/11/029410
• Lead Sponsor: Institute of medical sciencesBHU Varanasi

Brief Summary

the study of **Comparative study of negative pressure wound therapy versus conventional dressing for the management of traumatic wound**going 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-12
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 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

1. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Changes in wound size	Every 5 days
2)change in percentage of granulation tissue	Every 5 days
3)change in bacteria colony count	Every 5 days

Secondary Outcome Measures

Name	Time	Method
1) changes in blood counts	1 yr

Trial Locations

Locations (1)

Trauma Centre Institute of Medical Sciences BHU; 🇮🇳 Varanasi, UTTAR PRADESH, India

Trauma Centre Institute of Medical Sciences BHU

🇮🇳Varanasi, UTTAR PRADESH, India

Dr shashi prakash mishra

Principal investigator

8318530597

spmishra.gs@bhu.ac.in