Effect of Negative Pressure Wound Therapy for Soft Tissue Injuries of Foot and Ankle in Patients at a Tertiary Care Hospital
Principal Investigator
1 other identifier
interventional
70
1 country
1
Brief Summary
Effect of Negative Pressure Wound Therapy for Soft Tissue Iinjuries of Foot and Ankle in Patients at a Tertiary care Hospital. To evaluate the effect of negative pressure wound therapy for soft tissue injuries of foot and ankle.This will be assessed through measuring the wound surface area covered with healthy granulation tissue measured in centimetre square on follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedFirst Submitted
Initial submission to the registry
September 18, 2020
CompletedFirst Posted
Study publicly available on registry
September 29, 2020
CompletedSeptember 29, 2020
September 1, 2020
6 months
September 18, 2020
September 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
size of wound covered with healthy granulation tissue
The effect of technique was assessed through measuring wound surface area covered with healthy granulation tissue measured in centimetre square on follow-up.
27 days
Study Arms (2)
Negative Pressure Wound Therapy
EXPERIMENTALNegative Pressure Wound Therapy was applied to injured area of foot and ankle after debridement and cleaning of the necrosed/dead tissue. The effect of technique was assessed through measuring wound surface area covered with healthy granulation tissue measured in centimetre square on follow-up.
Conventional treatment
ACTIVE COMPARATORSimple moist gauze dressing applied to injured area of foot and ankle after debridement and cleaning of the necrosed/dead tissue. The effect of treatment was assessed through measuring wound surface area covered with healthy granulation tissue measured in centimetre square on follow-up.
Interventions
NPWT technique was applied to injured area of the foot and ankle after debridement and cleaning of the necrosed tissue and using Vacuum Assisted Closure (VAC) consisting of evacuation tube, vacuum pump, collecting canister and a multiporous polyurethane sponge. VAC dressings were changed every 72 hours.
In conventional treatment moist gauze dressings were applied and change of dressings were done daily.
Eligibility Criteria
You may qualify if:
- All patients aged 18 years or above with foot and ankle trauma resulting in soft tissue injury with bones and tendon exposed
- Patients consenting to participate in the study
You may not qualify if:
- Patients with uncontrolled diabetes mellitus
- Patients with multiple fractures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Roqayyah Munawwer Khursheed
Karachi, Sindh, 75850, Pakistan
Related Publications (1)
Lee HJ, Kim JW, Oh CW, Min WK, Shon OJ, Oh JK, Park BC, Ihn JC. Negative pressure wound therapy for soft tissue injuries around the foot and ankle. J Orthop Surg Res. 2009 May 9;4:14. doi: 10.1186/1749-799X-4-14.
PMID: 19426531BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roqayyah M Khursheed, MBBS
Dow University of Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- This study will be single blinded means that patient will be unaware of his/her treatment method.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 18, 2020
First Posted
September 29, 2020
Study Start
January 1, 2020
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
September 29, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share