NCT03602950

Brief Summary

this study will investigate the effectiveness of PRP in wound healing among diabetic patients undergoing elective cesarean sections

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

July 27, 2018

Status Verified

July 1, 2018

Enrollment Period

7 months

First QC Date

July 6, 2018

Last Update Submit

July 26, 2018

Conditions

Diabetes, GestationalWound Complication

Outcome Measures

Primary Outcomes (1)

  • changes in wound healing

    REEDA descriptive scale will assess degree of wound healing which formed of 4 points in a categorical score assessing 5 items of healing, redness, edema,ecchymosis,discharge ,approximation of the wound edges. each item is rated on a scale of 0-3 and total score may range between 0-15. lower scores indicating good healing

    one week post-operatively

Secondary Outcomes (1)

  • morbidly wound healing

    4-8weeks

Study Arms (2)

Control group

NO INTERVENTION

50 diabetic ladies at full term will undergo elective CS and will receive the usual surgical care routinely done at our hospital

study group

ACTIVE COMPARATOR

50 diabetic ladies will undergo elective CS at full term and autologous PRP will be injected subcutaneously before skin closure.

Biological: PRP

Interventions

PRPBIOLOGICAL

autologous PRP will be injected subcutaneously before skin closure at time of elective CS

study group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The intervention group will receive PRP at surgery, whereas the control group will receive the usual care. All patients will be evaluated at baseline, one week, four weeks and eight week after the cesarean section.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 6, 2018

First Posted

July 27, 2018

Study Start

August 1, 2018

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

July 27, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share