Comparative Study Using Negative Pressure Dressing With & Without Silver Alginate to Promote Healing in Chronic Wounds.
Primary Purpose
Wound Healing
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
silver alginate
VAC dressing without silver alginate
Sponsored by

About this trial
This is an interventional other trial for Wound Healing
Eligibility Criteria
Inclusion Criteria:
- Both genders above 18 years
- Wounds for more than 6 weeks
- History of trauma, tumor, congenital physical abnormalities
- Hemoglobin levels more than 10 g/dl
- Platelet count above 150 x 10E9/L
- Size of wound > 10*10cm.
Exclusion Criteria:
- Pressure ulcers
- Co-morbidities like diabetes or hypertension
- Bleeding vessels
- Presence of Necrotic tissue
- Malignancy in wounds
Sites / Locations
- Mahak
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
vac with silver
simple VAC without silver alginate
Arm Description
wounds of patients will be covered with a vac dressing with single layer of Ag+ hydrocolloid dressings. Such pattern of dressing will be followed in every change of dressing in 48 hours.
wounds of patients will be covered with VAC dressings only. Such pattern of dressing will be followed in every change of dressing in 48 hours.
Outcomes
Primary Outcome Measures
Granulation tissue
The wound site will be photographically monitored by a team of plastic surgeons to assess granulation tissue, by noting the size of wound, color and shine of granulation tissue and edema and also by questionnare fillled by patient.
size of wound.
he wound site will be photographically monitored by a team of plastic surgeons to assess granulation tissue, by noting the size of wound, color and shine of granulation tissue and edema and also by questionnare fillled by patient.
Secondary Outcome Measures
Full Information
NCT ID
NCT05009576
First Posted
July 29, 2021
Last Updated
August 11, 2021
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05009576
Brief Title
Comparative Study Using Negative Pressure Dressing With & Without Silver Alginate to Promote Healing in Chronic Wounds.
Official Title
Comparative Study Using Negative Pressure Dressing With & Without Silver Alginate to Promote Healing in Chronic Wounds.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
July 17, 2021 (Actual)
Study Completion Date
July 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The randomized control trial will be conducted in the Department of Plastic and Reconstructive Surgery at Dr. Ruth K.M. Pfau Civil Hospital Karachi.General population admitted in Civil Hospital Karachi, for wound coverage with skin grafting meetimg inclusion criteria will be included.
Detailed Description
Wound will be covered with negative pressure dressings that are composed of a sterile foam dressing surrounded by an occlusive film that adheres to the nearby, normal skin. Suction is applied to the dressing and a draining tube connect to a wall fixed assisted vacuum canister.
Patients will be provided with paper chits with A or B marked on it. Patients picking up A chit will be dealt as A group where wound will be covered with VAC dressings only where by patients picking up B chit will be dealt as B group where wound will be covered with a single layer of Ag+ hydrocolloid dressings. Such pattern of dressing will be followed in every change of dressing in 48 hours. The wound site will be photographed after every change of dressings. The wound site will be photographically monitored by a team of plastic surgeons to assess granulation tissue, by noting the size of wound, color and shine of granulation tissue and edema.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vac with silver
Arm Type
Active Comparator
Arm Description
wounds of patients will be covered with a vac dressing with single layer of Ag+ hydrocolloid dressings. Such pattern of dressing will be followed in every change of dressing in 48 hours.
Arm Title
simple VAC without silver alginate
Arm Type
Active Comparator
Arm Description
wounds of patients will be covered with VAC dressings only. Such pattern of dressing will be followed in every change of dressing in 48 hours.
Intervention Type
Other
Intervention Name(s)
silver alginate
Intervention Description
silver alginate hydrofiber dressing
Intervention Type
Other
Intervention Name(s)
VAC dressing without silver alginate
Intervention Description
vaccum assisted dressing
Primary Outcome Measure Information:
Title
Granulation tissue
Description
The wound site will be photographically monitored by a team of plastic surgeons to assess granulation tissue, by noting the size of wound, color and shine of granulation tissue and edema and also by questionnare fillled by patient.
Time Frame
6 days
Title
size of wound.
Description
he wound site will be photographically monitored by a team of plastic surgeons to assess granulation tissue, by noting the size of wound, color and shine of granulation tissue and edema and also by questionnare fillled by patient.
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Both genders above 18 years
Wounds for more than 6 weeks
History of trauma, tumor, congenital physical abnormalities
Hemoglobin levels more than 10 g/dl
Platelet count above 150 x 10E9/L
Size of wound > 10*10cm.
Exclusion Criteria:
Pressure ulcers
Co-morbidities like diabetes or hypertension
Bleeding vessels
Presence of Necrotic tissue
Malignancy in wounds
Facility Information:
Facility Name
Mahak
City
Karachi
State/Province
Sindh
ZIP/Postal Code
1234
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Study Using Negative Pressure Dressing With & Without Silver Alginate to Promote Healing in Chronic Wounds.
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