Wound HealNCT07525674
Vacuum Sealing Drainage (VSD) in Promoting Wound Healing and Reducing Complications in Post-Infected Obstetric and Gynecological Surgical Sites
A study testing Conventional Wound Care Group and Vacuum Sealing Drainage (VSD) Group in people with Wound Heal, run by Minia University at 1 site in Egypt.
Trial summary
This study aims to evaluate the efficacy of VSD in promoting wound healing and reducing complications, such as re-infection, prolonged hospitalization, and need for further surgical interventions, in obstetric and gynecological patients who have developed surgical site infections following their primary procedures. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Wound Heal
- What is being tested?
- Conventional Wound Care Group and Vacuum Sealing Drainage (VSD) Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2026to 20 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of a surgical site infection (SSI) following an obstetric or gynecological surgical procedure (e.g., Cesarean section, hysterectomy, myomectomy, salpingo-oophorectomy).
- Wound classification as superficial incisional SSI, deep incisional SSI, or organ/space SSI (if accessible for VSD application).
- Willingness and ability to provide informed consent.
- Wound requiring secondary intention healing or delayed primary closure after debridement
Who cannot join
- Patients with necrotic tissue.
- Presence of exposed blood vessels, organs, or anastomotic sites where VSD is contraindicated.
- Untreated coagulopathy or active bleeding diathesis.
- Allergy to VSD components or dressing materials.
- Patients with significant immunosuppression (e.g., uncontrolled HIV, organ transplant recipients on high-dose immunosuppressants).
- Patients with malignant wounds.
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- Patients who decline participation.
- Patients requiring immediate primary wound closure without debridement.
- Patients with a known history of severe psychiatric illness affecting compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Minia advanced laparoscopy unit
Minya
Mohamed abdelghfar, Lecturer, +20 10 61624335
About this study
This study aims to evaluate the efficacy of VSD in promoting wound healing and reducing complications, such as re-infection, prolonged hospitalization, and need for further surgical interventions, in obstetric and gynecological patients who have developed surgical site infections following their primary procedures. The investigators hypothesize that VSD will lead to faster wound healing, fewer complications, and improved patient outcomes compared to conventional wound care in this specific patient population.
- Conditions
- Wound Heal
- Being tested
- Conventional Wound Care Group, Vacuum Sealing Drainage (VSD) Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Wound Care GroupBiological
- Wounds will be managed with daily or twice-daily dressing changes using saline-moistened gauze, antiseptic solutions, and sterile dry dressings, as per standard hospital protocols for infected wounds
Vacuum Sealing Drainage (VSD) GroupBiological
After initial debridement, a VSD system will be applied to the wound bed. The wound will be sealed with an adhesive drape, and connected to a negative pressure unit.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Wound Care Group | Active comparator | Not described Receives: Biological: Conventional Wound Care Group |
| Vacuum Sealing Drainage (VSD) Group | Experimental | Not described Receives: Biological: Vacuum Sealing Drainage (VSD) Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete wound healing
Defined as complete epithelialization of the wound, measured in days
Measured: weekly follow up for one month after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start20 Apr 2026
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hassan Mohamed Abdel Ghfar, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525674
- Sponsor's protocol ID
- 1705-9-25
- Status last verified
- Jul 2026
- First submitted
- 6 Apr 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vacuum Sealing Drainage (VSD) in Promoting Wound Healing and Reducing Complications in Post-Infected Obstetric and Gynecological Surgical Sites
- ClinicalTrials.gov ID
- NCT07525674
- Acronym / sponsor ID
- 1705-9-25
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 13 Apr 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.
This study aims to evaluate the efficacy of VSD in promoting wound healing and reducing complications, such as re-infection, prolonged hospitalization, and need for further surgical interventions, in obstetric and gynecological patients who have developed surgical site infections following their primary procedures. The investigators hypothesize that VSD will lead to faster wound healing, fewer complications, and improved patient outcomes compared to conventional wound care in this specific patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Wound Care Group | Active comparator | Biological: Conventional Wound Care Group |
| Vacuum Sealing Drainage (VSD) Group | Experimental | Biological: Vacuum Sealing Drainage (VSD) Group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of a surgical site infection (SSI) following an obstetric or gynecological surgical procedure (e.g., Cesarean section, hysterectomy, myomectomy, salpingo-oophorectomy).
- Wound classification as superficial incisional SSI, deep incisional SSI, or organ/space SSI (if accessible for VSD application).
- Willingness and ability to provide informed consent.
- Wound requiring secondary intention healing or delayed primary closure after debridement
Key exclusion criteria (9 listed)
- Patients with necrotic tissue.
- Presence of exposed blood vessels, organs, or anastomotic sites where VSD is contraindicated.
- Untreated coagulopathy or active bleeding diathesis.
- Allergy to VSD components or dressing materials.
- Patients with significant immunosuppression (e.g., uncontrolled HIV, organ transplant recipients on high-dose immunosuppressants).
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 |
|---|---|---|
| Conventional Wound Care Groupo Wounds will be managed with daily or twice-daily dressing changes using saline-moistened gauze, antiseptic solutions, and sterile dry dressings, as per standard hospital protocols for infected wounds | Biological | Conventional Wound Care Group |
| Vacuum Sealing Drainage (VSD) GroupAfter initial debridement, a VSD system will be applied to the wound bed. The wound will be sealed with an adhesive drape, and connected to a negative pressure unit. | Biological | Vacuum Sealing Drainage (VSD) Group |
Primary outcome
Time to complete wound healing
Time frame: weekly follow up for one month after procedure
Defined as complete epithelialization of the wound, measured in days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Wound Care Group and Vacuum Sealing Drainage (VSD) Group in people with Wound Heal, run by Minia University 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 21 Jul 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed abdel ghfar (+20 10 61624335, mohamedeleboany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete wound healing (time frame: weekly follow up for one month after procedure). 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 Jul 2026.