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OpenTrials
Completed

NCT Number: NCT05009576

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahak

Karachi, Sindh, 1234, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

silver alginate

Other

silver alginate hydrofiber dressing

VAC dressing without silver alginate

Other

vaccum assisted dressing

Primary outcomes

  1. Granulation tissue

    Time frame: 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.

  2. size of wound.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2021
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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