PRP Use in Diabetic Patients Undergoing Cesarean Section

Phase 2

• Conditions: Diabetes, Gestational; Wound Complication
• Interventions: Biological: PRP

• Registration Number: NCT03602950
• Lead Sponsor: Minia University

Brief Summary

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

Detailed Description

In this balanced, randomized, and controlled prospective study, 100 pregnant ladies at full term diabetic patients will be admitted to Minia University hospital. The patients will be randomly assigned into two groups. 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, two weeks, four weeks and eight week after the cesarean section.

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2018-07-26
• Last Update Submitted: 2018-07-26
• Study First Posted: 2018-07-27
• Last Update Posted: 2018-07-27
• Study Start: 2018-08-01
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• The inclusion criteria will be a fixed factor along with age(18 y:45 y),diabetic patients(any type of diabetes),elective delivery,average body mass index(BMI) (17 : 24.9),Non previously scared uterus ,single pregnancy

Exclusion Criteria

• The exclusion criteria will be younger ages below 18 years ,older ages above 45 years, emergency caesarean delivery, previous scared uterus, underweight BMI below 17, overweight BMI above 24.9, no other medical problems, associated other diseases, and multiple pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
changes in wound healing	one week post-operatively	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

Secondary Outcome Measures

Name	Time	Method
morbidly wound healing	4-8weeks	at 4 and 8 weeks post-operatively the wound healing will be completed and will be assessed using VSS,Vancouver scar scale, which detect formation of keloid or hypertrophic scars. it will assess vascularity, scar thickness, pliability and pigmentation