Donor Site ComplicationPhase 4NCT06044519
A Single Center Trial of Donor Site Wound Dressings After Split Thickness Skin Grafting.
A Phase 4 study testing different types of dressings in people with Donor Site Complication and Skin Graft Scar, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Donor Site Complication, Skin Graft Scar
- What is being tested?
- different types of dressings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2022to 28 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- . 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
Who cannot join
- Patients on chemotherapy or corticosteroids were excluded from the study. Non-probability consecutive sampling was employed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Donor Site Complication, Skin Graft Scar
- Being tested
- different types of dressings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different types of dressingsBiological
different types of dressings were compared ti see the effectiveness for for STSG donor site wound
| Study group | Role | What they receive |
|---|---|---|
| alginate | Experimental | Not described Receives: Biological: different types of dressings |
| film | Experimental | Not described Receives: Biological: different types of dressings |
| guaze | Experimental | Not described Receives: Biological: different types of dressings |
| hydrocolloid | Experimental | Not described Receives: Biological: different types of dressings |
| hydrofiber | Experimental | Not described Receives: Biological: different types of dressings |
| silicon | Experimental | Not described Receives: Biological: different types of dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
to asses the effective of dressings by measuring itching , pain and scarring
scaring by POSAS SCORE, pain and itcting by VISUAL ANALOGUE SCAORE.
Measured: six month
Secondary outcomes (2)
patient satisfaction for scar
likert scale
Measured: six months
any complications
infection, hypergranulation, allergy
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Aug 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Donor Site ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044519
- Sponsor's protocol ID
- Approval/2022/943
- Status last verified
- Aug 2023
- First submitted
- 4 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre Randomized Control Trial of Donor Site Wound Dressing After Split Thickness Skin Grafting
- ClinicalTrials.gov ID
- NCT06044519
- Acronym / sponsor ID
- Approval/2022/943
- Conditions
- Donor Site Complication, Skin Graft Scar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- . 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
Key exclusion criteria (1 listed)
- Patients on chemotherapy or corticosteroids were excluded from the study. Non-probability consecutive sampling was employed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| different types of dressingsdifferent types of dressings were compared ti see the effectiveness for for STSG donor site wound | Biological | alginate, film, guaze, hydrocolloid, hydrofiber, silicon |
Primary outcome
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.
2 secondary outcomes
patient satisfaction for scar
Time frame: six months
any complications
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing different types of dressings in people with Donor Site Complication and Skin Graft Scar, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to asses the effective of dressings by measuring itching , pain and scarring (time frame: six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.