Local Injection of PRP During Repair of Disrupted Surgical Wounds

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: Role of Platelet Rich Plasma in Wound Healing
• Intervention / Treatment: Procedure: Platelet rich plasma infiltration in the wound edges; Procedure: Closure of wound without platelet rich plasma infiltration

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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 needed for complete wound closure	30 days
Duration of hospital stay	Time during which patient is admitted	30 days

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

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: Platelet rich plasma; disrupted wounds; Obstetrics and Gynecology
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• 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