Role of Platelet Rich Plasma in Wound HealingNCT03781882
Local Injection of PRP During Repair of Disrupted Surgical Wounds
A study testing Platelet rich plasma infiltration in the wound edges and Closure of wound without platelet rich plasma infiltration in people with Role of Platelet Rich Plasma in Wound Healing, run by Tanta University at 1 site in Egypt.
Trial summary
Patients with disrupted wounds will either managed as usual or managed by Platelet rich plasma local infiltration in the wound edges Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Role of Platelet Rich Plasma in Wound Healing
- What is being tested?
- Platelet rich plasma infiltration in the wound edges and Closure of wound without platelet rich plasma infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 31 Mar 2020
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Disrupted surgical wounds after cesarean sections and other gynecological operations
- Body mass index 18-25
- Hemoglobin > 10.5gm/dl
- Albumin >3.5gm/dl
Who cannot join
- Medical disorders asDiabetes mellitus (DM), Liver disease or systemic lupus erythymatosus (SLE)
- Patient on corticosteriod therapy
- Thrombocytopenia
- Coagulation disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Injection of Autologous Platelet Rich Plasma During Repair of Disrupted Surgical Wounds at Obstetrics and Gynecology Department: A Randomized Controlled Study
Patients with disrupted wounds will either managed as usual or managed by Platelet rich plasma local infiltration in the wound edges
Read the detailed description
The patients with disrupted surgical wounds will be cleansed, debrided and closed with infiltration of platelet rich plasma in one group and the other group will be closed without infiltration of Platelet rich plasma
- Being tested
- Platelet rich plasma infiltration in the wound edges, Closure of wound without platelet rich plasma infiltration
- Keywords
- Platelet rich plasma, disrupted wounds, Obstetrics and Gynecology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasma infiltration in the wound edgesProcedure or surgery
platelet rich plasma will be injected in the wound edges
Closure of wound without platelet rich plasma infiltrationProcedure or surgery
No infiltration of platelet rich plasma is done
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | All patients in this group will be manged as usual with infiltration of platelet rich plasma in thee wound edges during closure of the wounds Receives: Procedure: Platelet rich plasma infiltration in the wound edges |
| Control group | Active comparator | All patients in this group will be managed by repair of wounds without infiltration of platelet rich plasma Receives: Procedure: Closure of wound without platelet rich plasma infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete wound healing
time needed for complete wound closure
Measured: 30 days
Duration of hospital stay
Time during which patient is admitted
Measured: 30 days
Secondary outcomes (2)
Failure of complete wound healing
No complete closure
Measured: 30 days
Need fo tertiary suture
need to re-operate the case again
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Jan 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Role of Platelet Rich Plasma in Wound HealingStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Model description
- All cases with disrupted surgical wounds admitted at Obstetrics and Gynecology departments
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781882
- Sponsor's protocol ID
- PRP surgical wounds
- Status last verified
- May 2020
- First submitted
- 18 Dec 2018
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share unidentified data
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Injection of Autologous Platelet Rich Plasma During Repair of Disrupted Surgical Wounds at Obstetrics and Gynecology Department: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03781882
- Acronym / sponsor ID
- PRP surgical wounds
- Keywords
- Platelet rich plasma, disrupted wounds, Obstetrics and Gynecology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 20 Dec 2018 (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.
Patients with disrupted wounds will either managed as usual or managed by Platelet rich plasma local infiltration in the wound edges
Detailed description
The patients with disrupted surgical wounds will be cleansed, debrided and closed with infiltration of platelet rich plasma in one group and the other group will be closed without infiltration of Platelet rich plasma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All cases with disrupted surgical wounds admitted at Obstetrics and Gynecology departments
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Procedure: Platelet rich plasma infiltration in the wound edgesAll patients in this group will be manged as usual with infiltration of platelet rich plasma in thee wound edges during closure of the wounds |
| Control group | Active comparator | Procedure: Closure of wound without platelet rich plasma infiltrationAll patients in this group will be managed by repair of wounds without infiltration of platelet rich plasma |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Disrupted surgical wounds after cesarean sections and other gynecological operations
- Body mass index 18-25
- Hemoglobin > 10.5gm/dl
- Albumin >3.5gm/dl
Key exclusion criteria (4 listed)
- Medical disorders asDiabetes mellitus (DM), Liver disease or systemic lupus erythymatosus (SLE)
- Patient on corticosteriod therapy
- Thrombocytopenia
- Coagulation disorders
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 |
|---|---|---|
| Platelet rich plasma infiltration in the wound edgesplatelet rich plasma will be injected in the wound edges | Procedure or surgery | Intervention group |
| Closure of wound without platelet rich plasma infiltrationNo infiltration of platelet rich plasma is done | Procedure or surgery | Control group |
Primary outcome
Complete wound healing
Time frame: 30 days
time needed for complete wound closure
Duration of hospital stay
Time frame: 30 days
Time during which patient is admitted
2 secondary outcomes
Failure of complete wound healing
Time frame: 30 days
Need fo tertiary suture
Time frame: 30 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 14 May 2020.
- Individual participant dataSharing planned: Yes. We will share unidentified data
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 Platelet rich plasma infiltration in the wound edges and Closure of wound without platelet rich plasma infiltration in people with Role of Platelet Rich Plasma in Wound Healing, run by Tanta 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 4 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 14 May 2020. 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?
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?
Complete wound healing (time frame: 30 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 14 May 2020.