| CTRI Number |
CTRI/2025/07/091000 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of PRP for Faster Healing of Caesarean Section Wounds |
|
Scientific Title of Study
|
Study of efficacy of autologous platelet rich plasma (PRP) in healing of open post caesarian wound as compared to conventional standard of care at a tertiary care centre in Western Rajasthan: A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Teena Meena |
| Designation |
PG student |
| Affiliation |
Dr SN medical college,jodhpur ,Umaid hospital,obstretics and gynaecology department |
| Address |
Dr SN medical college,Umaid hospital, jodhpur, Obstretics and gynaecology
department
Umaid hospital,jodhpur,OBS and Gynae department
Jodhpur
RAJASTHAN
342003
India |
| Phone |
7340132219 |
| Fax |
|
| Email |
mteena957@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hanslata Gehlot |
| Designation |
Doctor(senior proffessor) |
| Affiliation |
Dr SN medical college ,jodhpur,Umaid hospital ,Obstretics and Gynaecology department |
| Address |
Dr SN medical college,Umaid hospital, jodhpur,Obstretics and Gynaecology department
Umaid hospital,Obs and gynae department ,jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9414135070 |
| Fax |
|
| Email |
pummyia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Teena Meena |
| Designation |
PG student |
| Affiliation |
Dr SN medical college ,jodhpur,Umaid hospital ,Obstretics abd Gynaecology department |
| Address |
Dr SN medical college,Umaid hospital, jodhpur, Obstretics and gynaecology
department
Umaid hospital ,jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
7340132219 |
| Fax |
|
| Email |
mteena957@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr S.N . Medical college, jodhpur 342003, India |
|
|
Primary Sponsor
|
| Name |
Dr SN Medical college jodhpur |
| Address |
Dr S.N. Medical college ,jodhpur ,Umaid hospital,342003,India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Teena Meena |
Umaid hospital |
Obstretics and Gynaecology department
Jodhpur
RAJASTHAN |
7340132219
mteena957@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC ,Dr SNMC,Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autologous PRP |
Freshly prepared autologous platelet-rich plasma (PRP), derived from the patient’s own blood, was applied topically over the post-caesarean surgical wound starting on postoperative Day 7. Each application consisted of approximately 3–5 mL of PRP under sterile conditions. A maximum of two applications were performed per participant, based on wound assessment. Standard aseptic dressing was applied following PRP administration. Participants were followed up for wound healing using REEDA scale, wound dimensions, and VAS score. |
| Comparator Agent |
Control group |
Participants in the control group received standard wound care using conventional sterile gauze dressing as per hospital protocol, starting from Day 7 post-caesarean section. Dressing was changed daily or as per wound condition until healing was complete. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Postpartum women with wound gap seven days after cesarean delivery that is after stitch removal.
1. Wound gap
Length 3 to 10cm
Width 1 to 3 cm
Depth 1.5 to 3 cms
2. REEDA Score more than 6 |
|
| ExclusionCriteria |
| Details |
criteria:-
1. Pt with unhealthy wound ( wound with infection or sloughing )
2. Pt with thrombocytopenia.
3. Morbidly obese BMI more than 35 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measure : The primary outcome measure is reduction in wound dimension and time taken for complete healing and hence change in MEAN REEDA Scale . |
Measure : The primary outcome measure is reduction in wound dimension at day 7 and day 14 and time taken for complete healing and hence change in MEAN REEDA Scale . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mean REEDA (Redness, Edema, Ecchymosis, Discharge, Approximation) score between groups
2. Mean VAS (Visual Analogue Scale) score for pain between groups |
At baseline,Day 7 and Day 14 post-LSCS
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized controlled trial conducted at a tertiary care center in Western Rajasthan to evaluate the efficacy of autologous platelet-rich plasma (PRP) in healing of post-caesarean surgical wounds as compared to conventional standard of care. Eligible post-LSCS women with wound gap (length 3–10 cm, width 1–3 cm, depth 1.5–3 cm, and REEDA score >6) on postoperative Day 7 were randomized into two groups. The intervention group received topical application of autologous PRP, while the control group received standard dressing. Wound healing was assessed using clinical parameters, REEDA score, and VAS score on Day 7 and Day 14. The study aims to compare the effectiveness of PRP in improving wound healing outcomes in post-caesarean patients.This is an academic, investigator-initiated study conducted at Umaid Hospital, Jodhpur as part of a postgraduate thesis project. All ethical guidelines were followed. Trial was initiated only after IEC approval. |