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

September 13, 2023 updated by: Dow University of Health Sciences

A Single Centre Randomized Control Trial of Donor Site Wound Dressing After Split Thickness Skin Grafting

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Dr Ruth KM Pfau civil hospital karachi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
six month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction for scar
Time Frame: six months
likert scale
six months
any complications
Time Frame: six months
infection, hypergranulation, allergy
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Approval/2022/943

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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