Local Injection of PRP During Repair of Disrupted Surgica... | NCT03781882

Studies
Local Injection of PRP During Repair of Disrupted Surgical Wounds

NCT03781882

Sponsor

Tanta University

Status

Completed

Last Update Posted

May 14, 2020Actual

Enrollment

220Actual

Phase

Not Applicable

Conditions

Role of Platelet Rich Plasma in Wound Healing

Interventions

Platelet rich plasma infiltration in the wound edges
Closure of wound without platelet rich plasma infiltration

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Mar 31, 2020Actual

Completion Date

Mar 31, 2020Actual

First Submitted Date

Dec 18, 2018

First Submission Date that Met QC Criteria

Dec 18, 2018

First Posted Date

Dec 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2020

Last Update Posted Date

May 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	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	Procedure: Closure of wound without platelet rich plasma infiltration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Platelet rich plasma infiltration in the wound edges	Procedure	platelet rich plasma will be injected in the wound edges	Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete wound healing	time needed for complete wound closure	30 days
Duration of hospital stay	Time during which patient is admitted	30 days

Secondary Outcomes

Measure	Description	Time Frame
Failure of complete wound healing	No complete closure	30 days
Need fo tertiary suture	need to re-operate the case again	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Disrupted surgical wounds after cesarean sections and other gynecological operations
Body mass index 18-25
Hemoglobin > 10.5gm/dl
Albumin >3.5gm/dl

Exclusion Criteria:

Medical disorders asDiabetes mellitus (DM), Liver disease or systemic lupus erythymatosus (SLE)
Patient on corticosteriod therapy
Thrombocytopenia
Coagulation disorders

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ayman Shehata Dawood		Tanta		31111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

We will share unidentified data

Types

Study Protocol

Time Frame

30 days

Access Criteria

Not provided

URL

Not provided