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

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.

Study Overview

• Status: Completed
• Conditions: Wound Healing
• Intervention / Treatment: Other: silver alginate; Other: VAC dressing without silver alginate

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 1234
      • Mahak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: vac with silver; 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.	Other: silver alginate; silver alginate hydrofiber dressing
Active Comparator: simple VAC 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.	Other: VAC dressing without silver alginate; vaccum assisted dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Actual): July 17, 2021
• Study Completion (Actual): July 17, 2021

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 11, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: memonmehak

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No