Previous IncisionPhase 1/2PRP-CSNCT02775747
PRP Gel in Wound Closure in Recurrent CS
A Phase 1/2 study testing platelet rich plasma gel and saline in people with Previous Incision and Scar; Previous Cesarean Section, run by Ain Shams University at 1 site in Egypt.
Trial summary
There is limited application of the use of PRP in obstetrics, therefore there is a need for assessment if it is efficacy in improving skin wound healing in cesarean section. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Previous Incision, Scar; Previous Cesarean Section
- What is being tested?
- platelet rich plasma gel and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2016to Apr 2017
- Phase
- Phase 1/2
- 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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- elective cesarean section
- Body mass index 18:25
- Hemoglobin more than 10.5 g/d
- Albumin within normal more than or equal 3.5 g/d
Who cannot join
- medical disorders(Diabetes mellitus,heart disease,hypertension,systemic lupus erythematosus)
- high risk pregnancy as (placenta previa,placenta accreta)
- patient on corticosteroids medication
- primigravida subjected cesarean section
- complicated cesarean section (increased operation time,blood transfusion, drain, scrubbing of multiple surgeons)
- cesarean section due to chorioaminionitis
- postoperative complication such as:postpartum hemorrhage, paralytic ileus, sever distention..) will be dropped out from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platelet Rich Plasma Gel in Wound Closure in Recurrent Cesarean Section:Randomized Controlled Trial
There is limited application of the use of PRP in obstetrics, therefore there is a need for assessment if it is efficacy in improving skin wound healing in cesarean section.
Read the detailed description
This study aims to assess the efficacy of injection of platelet rich plasma into the wound of recurrent cesarean section for improving wound healing and enhancing the shape of the wound in women undergoing cesarean section.
- Conditions
- Previous Incision, Scar; Previous Cesarean Section
- Being tested
- platelet rich plasma gel, saline
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasma gelBiological
Also called PRP, platelete rich plasma (PRP)
Platelet rich plasma is prepared from fresh whole blood which is collected from a peripheral vein stored in acid citrare dextrose solution A (ACD-A)anticoagulant and processed to increase platelets by separating various components of blood
salineBiological
64 controlled women with recurrent cesarean section and fullfit to all inclusion and exclusion craiteria will reseve saline injection at time of wound closure
| Study group | Role | What they receive |
|---|---|---|
| platelet rich plasma gel | Experimental | Injection of Platelet rich plasma (PRP) gel in 64 cases at time of wound closure in women undergoing cesarean section for improving wound healing after fullfit to all the inclusion and exclusion craiteria Receives: Biological: platelet rich plasma gel |
| Saline | Placebo comparator | 64 Controlled Women with recurrent cesarean section and fullfit to all the inclusion and exclusion craiteria will reseve saline injection at time of wound closure Receives: Biological: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of PRP in Wound healing in cesarean section by 100 mm visual analog scale
Efficacy of PRP in Wound healing in cesarean section by 100 mm visual analog scale (VAS) for wound healing
Measured: one month
Secondary outcomes (1)
Assessment of the Cosmetic results of the wound by Modified Vancouver scar scale
Assessment of the Cosmetic results of the wound by Modified Vancouver scar scale
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Previous IncisionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rasha medhat abdul-hady, Ain Shams University
- Investigators
- RASHA DR MEDHAT, MD, Principal investigator, Ain Shams UniversityRasha M Abdul-hady, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775747
- Sponsor's protocol ID
- PRP-CS
- Acronym
- PRP-CS
- Status last verified
- Apr 2016
- First submitted
- 7 May 2016
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma Gel in Wound Closure in Recurrent Cesarean Section:Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02775747
- Acronym / sponsor ID
- PRP-CS / PRP-CS
- Conditions
- Previous Incision, Scar; Previous Cesarean Section
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 18 May 2016 (estimated)
- 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.
There is limited application of the use of PRP in obstetrics, therefore there is a need for assessment if it is efficacy in improving skin wound healing in cesarean section.
Detailed description
This study aims to assess the efficacy of injection of platelet rich plasma into the wound of recurrent cesarean section for improving wound healing and enhancing the shape of the wound in women undergoing cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platelet rich plasma gel | Experimental | Biological: platelet rich plasma gelInjection of Platelet rich plasma (PRP) gel in 64 cases at time of wound closure in women undergoing cesarean section for improving wound healing after fullfit to all the inclusion and exclusion craiteria |
| Saline | Placebo comparator | Biological: saline64 Controlled Women with recurrent cesarean section and fullfit to all the inclusion and exclusion craiteria will reseve saline injection at time of wound closure |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- elective cesarean section
- Body mass index 18:25
- Hemoglobin more than 10.5 g/d
- Albumin within normal more than or equal 3.5 g/d
Key exclusion criteria (7 listed)
- medical disorders(Diabetes mellitus,heart disease,hypertension,systemic lupus erythematosus)
- high risk pregnancy as (placenta previa,placenta accreta)
- patient on corticosteroids medication
- primigravida subjected cesarean section
- complicated cesarean section (increased operation time,blood transfusion, drain, scrubbing of multiple surgeons)
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 gelAlso: PRP, platelete rich plasma (PRP)Platelet rich plasma is prepared from fresh whole blood which is collected from a peripheral vein stored in acid citrare dextrose solution A (ACD-A)anticoagulant and processed to increase platelets by separating various components of blood | Biological | platelet rich plasma gel |
| saline64 controlled women with recurrent cesarean section and fullfit to all inclusion and exclusion craiteria will reseve saline injection at time of wound closure | Biological | Saline |
Primary outcome
Efficacy of PRP in Wound healing in cesarean section by 100 mm visual analog scale
Time frame: one month
Efficacy of PRP in Wound healing in cesarean section by 100 mm visual analog scale (VAS) for wound healing
1 secondary outcome
Assessment of the Cosmetic results of the wound by Modified Vancouver scar scale
Time frame: one month
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 16 May 2017.
- Individual participant dataSharing planned: Undecided
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.
RASHA DR MEDHAT, MD principal investigator
Ain Shams University
Rasha M Abdul-hady, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing platelet rich plasma gel and saline in people with Previous Incision and Scar; Previous Cesarean Section, run by Ain Shams 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 7 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 16 May 2017. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Efficacy of PRP in Wound healing in cesarean section by 100 mm visual analog scale (time frame: one 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 16 May 2017; AzTrials last refreshed its copy on 2 Nov 2026.