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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05009576
Other study ID # memonmehak
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 17, 2020
Est. completion date July 17, 2021

Study information

Verified date August 2021
Source Dow University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date July 17, 2021
Est. primary completion date July 17, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
silver alginate
silver alginate hydrofiber dressing
VAC dressing without silver alginate
vaccum assisted dressing

Locations

Country Name City State
Pakistan Mahak Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 days
Primary 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. 6 days
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