Comparative Study Using Negative Pressure Dressing With & Without Silver Alginate to Promote Healing in Chronic Wounds.

Wound Healing Clinical Trial

Official title:

Comparative Study Using Negative Pressure Dressing With & Without Silver Alginate to Promote Healing in Chronic Wounds.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05009576
• Other study ID #: memonmehak
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Wound Healing
• Wounds and Injuries

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