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

Not Applicable

Completed

• Conditions: Wound Healing
• Interventions: Other: silver alginate; Other: VAC dressing without silver alginate

• Registration Number: NCT05009576
• Lead Sponsor: Dow University of Health Sciences

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.

Study Timeline

• Study Start: 2020-12-17
• Primary Completion: 2021-07-17
• Study Completion: 2021-07-17
• Study First Submitted: 2021-07-29
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-11
• Last Update Submitted: 2021-08-11
• Study First Posted: 2021-08-17
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vac with silver	silver alginate	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.
simple VAC without silver alginate	VAC dressing without silver alginate	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.

Primary Outcome Measures

Name	Time	Method
Granulation tissue	6 days	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.	6 days	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.

Trial Locations

Locations (1)

Mahak; 🇵🇰 Karachi, Sindh, Pakistan