Local Injection of PRP During Repair of Disrupted Surgical Wounds

May 12, 2020 updated by: Ayman S Dawood, MD, Tanta University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt, 31111
        • Ayman Shehata Dawood

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group
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
platelet rich plasma will be injected in the wound edges
Active Comparator: Control group
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
No infiltration of platelet rich plasma is done

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

December 18, 2018

First Submitted That Met QC Criteria

December 18, 2018

First Posted (Actual)

December 20, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2020

Last Update Submitted That Met QC Criteria

May 12, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP surgical wounds

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

We will share unidentified data

IPD Sharing Time Frame

30 days

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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