Split-thickness Skin Graft Donor SitesNCT07629076
Effectiveness of Negative Pressure Wound Therapy Dressing on Split-Thickness Skin Graft Donor Site Wound Healing
A study testing Negative Pressure Wound therapy and conventional dressing in people with Split-thickness Skin Graft Donor Sites and Wound Healing, run by Mahmoud Abdalla Hifny Taha at 1 site in Egypt.
Trial summary
Split-thickness skin grafting (STSG) is a cornerstone of reconstructive surgery, but donor sites often experience significant morbidity due to partial-thickness wounds created. Accelerating the re-epithelialization of these donor sites is crucial for minimizing complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Split-thickness Skin Graft Donor Sites, Wound Healing
- What is being tested?
- Negative Pressure Wound therapy and conventional dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 30 Aug 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The inclusion criteria were patients who required a split-thickness skin graft procedure due to any etiology, had donor site wounds not exceeding 5% of the total body surface area, and complied with the necessary wound care and follow-up protocols.
Who cannot join
- The exclusion criteria included patients who had physical or cognitive impairment and were unable to provide informed consent or comply with necessary wound protocol, as well as patients on anticoagulant, corticosteroid, or chemotherapy treatment. Additionally, patients with donor site wounds exceeding 5% of their total body surface area were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Split-thickness skin grafting (STSG) is a cornerstone of reconstructive surgery, but donor sites often experience significant morbidity due to partial-thickness wounds created. Accelerating the re-epithelialization of these donor sites is crucial for minimizing complications. Negative pressure wound therapy (NPWT) has shown potential in enhancing the re-epithelialization of donor site wounds. However, further research is needed to compare NPWT's efficacy against conventional normal pressure dressings comprehensively. This study aims to compare the effectiveness of NPWT with conventional dressings in promoting skin graft donor sites healing.
Read the detailed description
Split-thickness skin grafting (STSG) is a cornerstone of reconstructive surgery, but donor sites often experience significant morbidity due to partial-thickness wounds created. Accelerating the re-epithelialization of these donor sites is crucial for minimizing complications. Negative pressure wound therapy (NPWT) has shown potential in enhancing the re-epithelialization of donor site wounds. However, further research is needed to compare NPWT's efficacy against conventional normal pressure dressings comprehensively. This study aims to compare the effectiveness of NPWT with conventional dressings in promoting skin graft donor sites healing.
- Being tested
- Negative Pressure Wound therapy, conventional dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound therapyProcedure or surgery
In the NPWT method, we first applied non-adherent petroleum gauze to the donor site wound. The NPWT system (Model: NP-800, Medway Inc., Suwanee GA, USA) was then fixed, and the pressure was continuously set to 100 mm Hg for seven days. On the 7th postoperative day, the NPWT system was removed and replaced with a conventional dressing while keeping the inner petroleum gauze dressing in situ.
conventional dressingProcedure or surgery
In the conventional dressing method, the donor wound was first covered by non-adherent petroleum gauze (Sufre-tulle) and then managed in a closed fashion, with gauze and cotton as a secondary normal pressure dressing. The secondary dressing was changed depending upon the associate's dressing soaking, hematoma, or suspicion of wound infection without disruption of underlying petroleum gauze.
| Study group | Role | What they receive |
|---|---|---|
| NPWT Group | Active comparator | All patients enrolled in this study were their own controls with two STSG donor sites per patient. Each patient had two skin graft donor sites, one on each thigh, with one site treated with negative-pressure wound therapy dressings and the other treated with conventional dressings using petroleum gauze without application of negative pressure. The assignment of dressing methods was randomized using a simple randomization technique.
Split-thickness donor site wound management All skin grafts were consistently harvested from the proximal anterolateral thigh region, using an electrically powered dermatome (Zimmer, Zimmer Surgical Inc.). The thickness of the skin grafts was uniformly set at 0.3 mm to minimize variability across cases. Receives: Procedure: Negative Pressure Wound therapy |
| Conventional Group | Sham comparator | All patients enrolled in this study were their own controls with two STSG donor sites per patient. Each patient had two skin graft donor sites, one on each thigh, with one site treated with negative-pressure wound therapy dressings and the other treated with conventional dressings using petroleum gauze without application of negative pressure. The assignment of dressing methods was randomized using a simple randomization technique.
Split-thickness donor site wound management All skin grafts were consistently harvested from the proximal anterolateral thigh region, using an electrically powered dermatome (Zimmer, Zimmer Surgical Inc.). The thickness of the skin grafts was uniformly set at 0.3 mm to minimize variability across cases. Receives: Procedure: conventional dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The complete re-epithelialization time
The time to complete re-epithelialization, or healing time, was defined as the number of days required to achieve full epithelialization of the donor site, with no further need for wound dressing. Epithelialization was considered complete when the entire wound area of the STSG donor site was covered with epithelium.
Measured: 14 days
Assessment of the re-epithelialization
The re-epithelialization was assessed on the 14th day after completely removing the dressing from both donor sites. Photographs of the donor sites were taken, and the percentage of epithelialization was quantified by analyzing the images using histogram-based image processing software (Adobe Photoshop R). The histogram depicts the distribution of pixels in an image by graphing the number of pixels at each color intensity level. The non-epithelialized area was initially identified and selected using the color range tool. The Fuzziness toolbar was then adjusted to select any missing tissues, including the entire non-epithelialized area. The number of pixels within the selection was determined, and the percentage of epithelialization was calculated by dividing the number of pixels in the non-epithelialized area by the total number of pixels within the total donor site wound surface area.
Measured: 14 days
Secondary outcomes (2)
pain intensity
Pain was objectively assessed using a visual analog scale, which scored the pain from 0 (no pain) to 10 (worst pain). The pain intensities of both sides of the donor site wound were recorded, and each patient reported their feelings of pain at the donor site wound on postoperative days 1, 2, 3, and 7.
Measured: 7 days
Dressing changes
The frequency of dressing changes required until complete donor site wound healing was recorded.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Jan 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Split-thickness Skin Graft Donor SitesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahmoud Abdalla Hifny Taha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Abdalla Hifny Taha, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629076
- Sponsor's protocol ID
- bode:SVU-MED-PIS013-4-24-7-883
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Negative Pressure Wound Therapy Dressing on Split-Thickness Skin Graft Donor Site Wound Healing
- ClinicalTrials.gov ID
- NCT07629076
- Acronym / sponsor ID
- bode:SVU-MED-PIS013-4-24-7-883
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mahmoud Abdalla Hifny TahaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 5 Jun 2026 (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.
Split-thickness skin grafting (STSG) is a cornerstone of reconstructive surgery, but donor sites often experience significant morbidity due to partial-thickness wounds created. Accelerating the re-epithelialization of these donor sites is crucial for minimizing complications. Negative pressure wound therapy (NPWT) has shown potential in enhancing the re-epithelialization of donor site wounds. However, further research is needed to compare NPWT's efficacy against conventional normal pressure dressings comprehensively. This study aims to compare the effectiveness of NPWT with conventional dressings in promoting skin graft donor sites healing.
Detailed description
Split-thickness skin grafting (STSG) is a cornerstone of reconstructive surgery, but donor sites often experience significant morbidity due to partial-thickness wounds created. Accelerating the re-epithelialization of these donor sites is crucial for minimizing complications. Negative pressure wound therapy (NPWT) has shown potential in enhancing the re-epithelialization of donor site wounds. However, further research is needed to compare NPWT's efficacy against conventional normal pressure dressings comprehensively. This study aims to compare the effectiveness of NPWT with conventional dressings in promoting skin graft donor sites healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPWT Group | Active comparator | Procedure: Negative Pressure Wound therapyAll patients enrolled in this study were their own controls with two STSG donor sites per patient. Each patient had two skin graft donor sites, one on each thigh, with one site treated with negative-pressure wound therapy dressings and the other treated with conventional dressings using petroleum gauze without application of negative pressure. The assignment of dressing methods was randomized using a simple randomization technique. Split-thickness donor site wound management All skin grafts were consistently harvested from the proximal anterolateral thigh region, using an electrically powered dermatome (Zimmer, Zimmer Surgical Inc.). The thickness of the skin grafts was uniformly set at 0.3 mm to minimize variability across cases. |
| Conventional Group | Sham comparator | Procedure: conventional dressingAll patients enrolled in this study were their own controls with two STSG donor sites per patient. Each patient had two skin graft donor sites, one on each thigh, with one site treated with negative-pressure wound therapy dressings and the other treated with conventional dressings using petroleum gauze without application of negative pressure. The assignment of dressing methods was randomized using a simple randomization technique. Split-thickness donor site wound management All skin grafts were consistently harvested from the proximal anterolateral thigh region, using an electrically powered dermatome (Zimmer, Zimmer Surgical Inc.). The thickness of the skin grafts was uniformly set at 0.3 mm to minimize variability across cases. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria were patients who required a split-thickness skin graft procedure due to any etiology, had donor site wounds not exceeding 5% of the total body surface area, and complied with the necessary wound care and follow-up protocols.
Key exclusion criteria (1 listed)
- The exclusion criteria included patients who had physical or cognitive impairment and were unable to provide informed consent or comply with necessary wound protocol, as well as patients on anticoagulant, corticosteroid, or chemotherapy treatment. Additionally, patients with donor site wounds exceeding 5% of their total body surface area were excluded.
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 |
|---|---|---|
| Negative Pressure Wound therapyIn the NPWT method, we first applied non-adherent petroleum gauze to the donor site wound. The NPWT system (Model: NP-800, Medway Inc., Suwanee GA, USA) was then fixed, and the pressure was continuously set to 100 mm Hg for seven days. On the 7th postoperative day, the NPWT system was removed and replaced with a conventional dressing while keeping the inner petroleum gauze dressing in situ. | Procedure or surgery | NPWT Group |
| conventional dressingIn the conventional dressing method, the donor wound was first covered by non-adherent petroleum gauze (Sufre-tulle) and then managed in a closed fashion, with gauze and cotton as a secondary normal pressure dressing. The secondary dressing was changed depending upon the associate's dressing soaking, hematoma, or suspicion of wound infection without disruption of underlying petroleum gauze. | Procedure or surgery | Conventional Group |
Primary outcome
The complete re-epithelialization time
Time frame: 14 days
The time to complete re-epithelialization, or healing time, was defined as the number of days required to achieve full epithelialization of the donor site, with no further need for wound dressing. Epithelialization was considered complete when the entire wound area of the STSG donor site was covered with epithelium.
Assessment of the re-epithelialization
Time frame: 14 days
The re-epithelialization was assessed on the 14th day after completely removing the dressing from both donor sites. Photographs of the donor sites were taken, and the percentage of epithelialization was quantified by analyzing the images using histogram-based image processing software (Adobe Photoshop R). The histogram depicts the distribution of pixels in an image by graphing the number of pixels at each color intensity level. The non-epithelialized area was initially identified and selected using the color range tool. The Fuzziness toolbar was then adjusted to select any missing tissues, including the entire non-epithelialized area. The number of pixels within the selection was determined, and the percentage of epithelialization was calculated by dividing the number of pixels in the non-epithelialized area by the total number of pixels within the total donor site wound surface area.
2 secondary outcomes
pain intensity
Time frame: 7 days
Dressing changes
Time frame: 14 days
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 5 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Split-thickness Skin Graft Donor Sites
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Autologous Skin Cell Suspension (RECELL®) for Accelerated Healing of Split-Thickness Skin Graft Donor Sites: A Randomized, Intra-Patient (Split-Site) Controlled Trial
Skin Graft Donor Site, Wound Healing
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 study testing Negative Pressure Wound therapy and conventional dressing in people with Split-thickness Skin Graft Donor Sites and Wound Healing, run by Mahmoud Abdalla Hifny Taha at 1 site in Egypt.
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 5 Jun 2026. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The complete re-epithelialization time (time frame: 14 days). The study lists 2 primary outcomes in all. 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 5 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.