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

NCT05009576 | Completed DMC

• 1 other identifier: memonmehak
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

vac with silver

ACTIVE COMPARATOR

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

simple VAC without silver alginate

ACTIVE COMPARATOR

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

Interventions

silver alginate OTHER

silver alginate hydrofiber dressing

vac with silver

VAC dressing without silver alginate OTHER

vaccum assisted dressing

simple VAC without silver alginate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pressure ulcers
• Co-morbidities like diabetes or hypertension
• Bleeding vessels
• Presence of Necrotic tissue
• Malignancy in wounds

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Mahak

Karachi, Sindh, 1234, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 17, 2021
• Study Start: December 17, 2020
• Primary Completion: July 17, 2021
• Study Completion: July 17, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)