| CTRI Number |
CTRI/2017/01/007659 [Registered on: 10/01/2017] Trial Registered Retrospectively |
| Last Modified On: |
06/01/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison of two different suture materials for revising scars |
|
Scientific Title of Study
|
Comparative evaluation of outcome of scar revision with the use of Polyglactin 910 versus Polydioxanone sutures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepti Gupta |
| Designation |
Senior Resident |
| Affiliation |
Safdarjung Hospital and VMMC |
| Address |
Ring Road, Opposite AIIMS Hospital, Safdarjung West, Safdarjung Campus, Ansari Nagar East, New Delhi, Delhi 110029
Ring Road, Opposite AIIMS Hospital, Safdarjung West, Safdarjung Campus, Ansari Nagar East, New Delhi, Delhi 110029
South
DELHI
110029
India |
| Phone |
9968185983 |
| Fax |
|
| Email |
deepti2611@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Upendra Sharma |
| Designation |
Professor |
| Affiliation |
Department of Burns and Plastic Surgery, Safdarjung Hospital and VMMC |
| Address |
Ring Road, Opposite AIIMS Hospital, Safdarjung West, Safdarjung Campus, Ansari Nagar East, New Delhi, Delhi 110029
Ring Road, Opposite AIIMS Hospital, Safdarjung West, Safdarjung Campus, Ansari Nagar East, New Delhi, Delhi 110029
South
DELHI
110029
India |
| Phone |
09873779009 |
| Fax |
|
| Email |
sharmaupendra97@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepti Gupta |
| Designation |
Senior Resident |
| Affiliation |
Safdarjung Hospital and VMMC |
| Address |
Ring Road, Opposite AIIMS Hospital, Safdarjung West, Safdarjung Campus, Ansari Nagar East, New Delhi, Delhi 110029
Ring Road, Opposite AIIMS Hospital, Safdarjung West, Safdarjung Campus, Ansari Nagar East, New Delhi, Delhi 110029
South
DELHI
110029
India |
| Phone |
9968185983 |
| Fax |
|
| Email |
deepti2611@gmail.com |
|
|
Source of Monetary or Material Support
|
| Safdarjung Hospital , Opposite AIIMS, Ansari Nagar east, Delhi -29 |
|
|
Primary Sponsor
|
| Name |
Safdarjung Hospital |
| Address |
Department of Burns, Plastic and Maxillofacial Surgery, Safdarjung Hospital |
| 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 Deepti Gupta |
Safdarjung Hospital |
Department of Burns,Plastic and Maxillofacial Surgery, Safdarjung Hospital, Opposite AIIMS, Ansari Nagar
South
DELHI |
9968185983
deepti2611@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
facial scars, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Polydioxanone suture |
6-0 Polydioxanone suture , Absorbable suture material used for dermal suturing during scar revision surgery. Patient will be monitored for scar spread in post operative period for four months. |
| Comparator Agent |
Polyglactin 910 |
Polyglactin 910 suture :Absorbable suture material used for dermal suturing during scar revision surgery. Patient will be monitored for scar spread in post operative period for four months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
One or more post traumatic facial scars, older than 1 year in duration |
|
| ExclusionCriteria |
| Details |
Scar width more than 1 cm, hypertrophic scars or keloids, known cases of bleeding, collagen or elastin disorders |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| scar spread in mm measured by a digital vernier caliper |
1, 3 and 4 months post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| vancouver scar scale score |
1, 3 and 4 months post operatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Scar revision is a commonly sought after procedure, especially for scars on the face. But scar revision procedures are fraught with widening of the revised scars due to tension forces across the scar. Elliptical excision and bilayered closure is a simple method for revising an unsightly scar. Polyglactin 910 remains the most commonly used absorbable suture for dermal closure, but loses its tensile strength in approximately 3 weeks, by which the wound has not gained enough strength to withstand the tensile forces. Polydioxanone, another absorbable suture, is known to provide longer wound support as compared to polyglactin 910. We in our study, wanted to compare the scar spread and scar quality with the use of these two absorbable sutures and see if one is better than the other. |