| CTRI Number |
CTRI/2024/03/063489 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Retro Prospective Analysis of PMMC Flap for Reconstruction of Head and Neck Region Defects |
|
Scientific Title of Study
|
A Retro-Prospective analysis of PMMC flap for reconstruction of Head and Neck region defects" |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tirumal Rao Patwari |
| Designation |
Mch Resident |
| Affiliation |
Goa Medical College |
| Address |
Department of Plastic Surgery and Burns, Goa Medical College, Bambolim, Goa
North Goa
GOA
403202
India |
| Phone |
7760426414 |
| Fax |
|
| Email |
tiru_patwari@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yuri Dias Amborcar |
| Designation |
Professor and HOD |
| Affiliation |
Goa Medical College |
| Address |
Department of Plastic Surgery and Burns, Goa Medical College, Bambolim, Goa
North Goa
GOA
403202
India |
| Phone |
9890065826 |
| Fax |
|
| Email |
yuridias2003@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yuri Dias Amborcar |
| Designation |
Professor and HOD |
| Affiliation |
Goa Medical College |
| Address |
Department of Plastic Surgery and Burns, Goa Medical College, Bambolim, Goa
GOA
403202
India |
| Phone |
9890065826 |
| Fax |
|
| Email |
yuridias2003@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tirumal Rao Patwari |
| Address |
Department of Plastic Surgery and Burns, Goa Medical College, Bambolim, Goa |
| Type of Sponsor |
Other [Self] |
|
|
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 Tirumal Rao Patwari |
Goa Medical College |
Department of Plastic Surgery and Burns, Goa Medical College, Bambolim, Goa
North Goa
GOA |
7760426414
tiru_patwari@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients who underwent PMMC flap reconstruction for head and neck defects from January 2018 to January 2025.
Patients who gave consent were included in the study. |
|
| ExclusionCriteria |
| Details |
Patients with lack of medical records and follow up
Patients with recurrence |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post op Complications -
- Infection
- Hematoma
- Immediate flap necrosis
- Fistula
- Wound dehiscence |
Post op day 1, 3, 5, 7 till patient is discharged. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Analyse the long term outcomes in terms of functional status of recipient and donor area -
Bulging,
Feeding,
Range of neck motion,
Shoulder mobility,
Breast deformity. |
At 3, 6, 12 months |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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)
|
11/03/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
- Pectoralis myocutaneous flap remains the workhorse for the reconstruction of large defects in the head and neck region despite free flaps gaining popularity.
- Even in our institution, free tissue transfers are carried out on a regular basis, but there is a deï¬nite scope and role for PMMC flap in reconstruction.
- We present our experience with pectoralis major myocutaneous flap in terms of postoperative complications, donor site morbidity, flap survival and long-term outcomes of the flap.
- It is a retro- prospective analysis of 43 patients who underwent Pectoralis Myocutaneous flap reconstruction from January 2018 to January 2025 in Department of Plastic Surgery at Goa Medical College.
- The objective of this study is to analyse the long term outcomes in terms of functional status of recipient and donor area - Bulging, Feeding, Range of neck motion, Shoulder mobility, Breast deformity.
|