Effect of Negative Pressure Wound Therapy for Soft Tissue Injuries of Foot and Ankle in Patients at a Tertiary Care Hospital
Principal Investigator
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All patients aged 18 years or above with foot and ankle trauma resulting in soft tissue injury with or without bones and tendon exposed were included in the study. 35 patients were randomized into Negative Pressure Wound Therapy group and 35 in conventional treatment group.In NPWT group ,NPWT 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 at 10 days ,20 days and 27 days respectively.
In Conventional treatment group patients were kept on simple moist gauze dressings and the wound was assessed through measuring wound surface area covered with healthy granulation tissue measured in centimeter square on followup at 10 days , 20 days and 27 days respectively.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 75850
- Roqayyah Munawwer Khursheed
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with uncontrolled diabetes mellitus
- Patients with multiple fractures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Negative Pressure Wound Therapy
Negative 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.
|
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.
|
|
Active Comparator: Conventional treatment
Simple 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.
|
In conventional treatment moist gauze dressings were applied and change of dressings were done daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
size of wound covered with healthy granulation tissue
Time Frame: 27 days
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Roqayyah M Khursheed, MBBS, Dow University of Health Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1408
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.