NCT06044519

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

September 4, 2023

Last Update Submit

September 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • to asses the effective of dressings by measuring itching , pain and scarring

    scaring by POSAS SCORE, pain and itcting by VISUAL ANALOGUE SCAORE.

    six month

Secondary Outcomes (2)

  • patient satisfaction for scar

    six months

  • any complications

    six months

Study Arms (6)

alginate

EXPERIMENTAL
Biological: different types of dressings

film

EXPERIMENTAL
Biological: different types of dressings

guaze

EXPERIMENTAL
Biological: different types of dressings

hydrocolloid

EXPERIMENTAL
Biological: different types of dressings

hydrofiber

EXPERIMENTAL
Biological: different types of dressings

silicon

EXPERIMENTAL
Biological: different types of dressings

Interventions

different types of dressings were compared ti see the effectiveness for for STSG donor site wound

alginatefilmguazehydrocolloidhydrofibersilicon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients on chemotherapy or corticosteroids were excluded from the study. Non-probability consecutive sampling was employed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Ruth KM Pfau civil hospital karachi

Karachi, Sindh, 74200, Pakistan

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2023

First Posted

September 21, 2023

Study Start

August 1, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

September 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations