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

NCT ID: NCT05009576

Last Updated: 2021-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-17

Study Completion Date

2021-07-17

Brief Summary

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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

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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.

Conditions

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Wound Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

silver alginate

Intervention Type OTHER

silver alginate hydrofiber dressing

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.

Group Type ACTIVE_COMPARATOR

VAC dressing without silver alginate

Intervention Type OTHER

vaccum assisted dressing

Interventions

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silver alginate

silver alginate hydrofiber dressing

Intervention Type OTHER

VAC dressing without silver alginate

vaccum assisted dressing

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mahak Ali

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mahak

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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memonmehak

Identifier Type: -

Identifier Source: org_study_id

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