Back to resultsLocal Injection of PRP During Repair of Disrupted Surgical Wounds
Primary Purpose
Role of Platelet Rich Plasma in Wound Healing
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Platelet rich plasma infiltration in the wound edges
Closure of wound without platelet rich plasma infiltration
Sponsored by
About this trial
This is an interventional treatment trial for Role of Platelet Rich Plasma in Wound Healing focused on measuring Platelet rich plasma, disrupted wounds, Obstetrics and Gynecology
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
Sites / Locations
- Ayman Shehata Dawood
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
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
All patients in this group will be managed by repair of wounds without infiltration of platelet rich plasma
Outcomes
Primary Outcome Measures
Complete wound healing
time needed for complete wound closure
Duration of hospital stay
Time during which patient is admitted
Secondary Outcome Measures
Failure of complete wound healing
No complete closure
Need fo tertiary suture
need to re-operate the case again
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03781882
Brief Title
Local Injection of PRP During Repair of Disrupted Surgical Wounds
Official Title
Local Injection of Autologous Platelet Rich Plasma During Repair of Disrupted Surgical Wounds at Obstetrics and Gynecology Department: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Role of Platelet Rich Plasma in Wound Healing
Keywords
Platelet rich plasma, disrupted wounds, Obstetrics and Gynecology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All cases with disrupted surgical wounds admitted at Obstetrics and Gynecology departments
Masking
Participant
Masking Description
Patients were not allowed to know allocations
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
All patients in this group will be managed by repair of wounds without infiltration of platelet rich plasma
Intervention Type
Procedure
Intervention Name(s)
Platelet rich plasma infiltration in the wound edges
Intervention Description
platelet rich plasma will be injected in the wound edges
Intervention Type
Procedure
Intervention Name(s)
Closure of wound without platelet rich plasma infiltration
Intervention Description
No infiltration of platelet rich plasma is done
Primary Outcome Measure Information:
Title
Complete wound healing
Description
time needed for complete wound closure
Time Frame
30 days
Title
Duration of hospital stay
Description
Time during which patient is admitted
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Failure of complete wound healing
Description
No complete closure
Time Frame
30 days
Title
Need fo tertiary suture
Description
need to re-operate the case again
Time Frame
30 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ayman Shehata Dawood
City
Tanta
ZIP/Postal Code
31111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share unidentified data
IPD Sharing Time Frame
30 days
Learn more about this trial
Local Injection of PRP During Repair of Disrupted Surgical Wounds
We'll reach out to this number within 24 hrs