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A Single Center Trial of Donor Site Wound Dressings After Split Thickness Skin Grafting.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06044519
Recruitment Status : Completed
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Dow University of Health Sciences

Study Description
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Brief Summary:

The goal of this clinical trial] is to compare different types of dressings used and there outcomes on STSG donor site wound. The main question[s] it aims to answer are:

  • the effectiveness of different donor site dressings and their adverse outcomes
  • the satisfaction of patients with the donor site dressing will be observed. Participants will randomly allocated different types of dressings for split thickness skin graft donor site wound which include alginate hydrocolloid hydrofiber silicon film guaze

Condition or disease Intervention/treatment Phase
Donor Site Complication Skin Graft Scar Biological: different types of dressings Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: A Single Centre Randomized Control Trial of Donor Site Wound Dressing After Split Thickness Skin Grafting
Actual Study Start Date : August 1, 2022
Actual Primary Completion Date : February 28, 2023
Actual Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: alginate Biological: different types of dressings
different types of dressings were compared ti see the effectiveness for for STSG donor site wound
Experimental: film Biological: different types of dressings
different types of dressings were compared ti see the effectiveness for for STSG donor site wound
Experimental: guaze Biological: different types of dressings
different types of dressings were compared ti see the effectiveness for for STSG donor site wound
Experimental: hydrocolloid Biological: different types of dressings
different types of dressings were compared ti see the effectiveness for for STSG donor site wound
Experimental: hydrofiber Biological: different types of dressings
different types of dressings were compared ti see the effectiveness for for STSG donor site wound
Experimental: silicon Biological: different types of dressings
different types of dressings were compared ti see the effectiveness for for STSG donor site wound


Outcome Measures
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Primary Outcome Measures :
  1. to asses the effective of dressings by measuring itching , pain and scarring [ Time Frame: six month ]
    scaring by POSAS SCORE, pain and itcting by VISUAL ANALOGUE SCAORE.


Secondary Outcome Measures :
  1. patient satisfaction for scar [ Time Frame: six months ]
    likert scale

  2. any complications [ Time Frame: six months ]
    infection, hypergranulation, allergy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • . Patients of aged 18 years and above of either gender underwent single donor-site wounds after split-skin grafting and surface area larger than 10 cm2 were included in the study

Exclusion Criteria:

  • Patients on chemotherapy or corticosteroids were excluded from the study. Non-probability consecutive sampling was employed
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06044519


Locations
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Pakistan
Dr Ruth KM Pfau civil hospital karachi
Karachi, Sindh, Pakistan, 74200
Sponsors and Collaborators
Dow University of Health Sciences
More Information
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Responsible Party: Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT06044519    
Other Study ID Numbers: Approval/2022/943
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes