Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04710719
Status:
COMPLETED
Last Update Posted:
2022-07-22
First Post:
2021-01-12
Brief Title:
Post-Surgical Injection With Triamcinolone Versus TriamcinoloneFluorouracil in Treatment of Keloids
Sponsor:
Our Lady of the Lake Hospital
Organization:
Our Lady of the Lake Hospital
Study Overview
Official Title:
Efficacy of Post-Surgical Intralesional Injection With Triamcinolone Versus Triamcinolone Plus Fluorouracil in the Treatment of Keloids
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There have been many modalities utilized in the treatment of keloids of the head and neck however none have been universally successful The most widely utilized non-surgical intervention is primary intralesional injection with triamcinolone TAC which inhibits the proliferation of fibroblasts inhibits collagen synthesis and increases collagenase production or fluorouracil 5-FU a potent inhibitor of fibroblast proliferation Despite the abundance of studies evaluating primary intralesional injection for keloids there are limited studies available regarding the efficacy of primary surgical excision followed by adjuvant intralesional injection The proposed study herein would serve to improve the level of evidence and to establish the safety and efficacy of combined intralesional TAC5FU for keloids following surgical excision
Detailed Description:
This is a single blinded prospective randomized controlled trial of patients who elect for surgical treatment of keloids at the Center for Facial Plastic and Reconstructive Surgery at Our Lady of the Lake Regional Medical Center OLOLRMC a tertiary referral center affiliated with the Louisiana State University Health Sciences Center LSUHSC teaching system Power analysis estimated approximately 134 patients total 67 per group for 80 power to detect a difference at the 5 confidence level This is based off of a prior groups study comparing primary intralesional injection with TAC vs TAC5FU no surgery That study showed 392 recurrence with TAC vs 175 with TAC5FU
The patients enrolled in the study will be randomized to one of two arms surgical excisionTAC or surgical excisionTAC5FU Randomization will be performed using a permuted block randomization algorithm Ex AABBABABABBABBAA where ATAC only group and BTAC 5FU All patients will undergo surgical excision of the keloid either under general anesthesia in the operating room or local anesthesia in the clinic setting depending on patient age and preference The goal of excision will be complete extra-lesional excision with primary closure It will be noted if a patient requires intra-lesional excision or additional reconstructive techniques such as advancement flap skin grafting or allografting ie Integra Monofilament sutures will be used preferentially to prevent local inflammatory reaction which can precipitate keloid formation In group 1 surgical excisionTAC all patients will be treated with adjuvant intralesional TAC 40mgmL 7-10 days post-op and then every 4 weeks for a total of 3 injections The triamcinolone vial will be obtained from pharmacy and drawn up by the physician prior to injection In group 2 surgical excisionTAC5FU all patients will be treated with adjuvant intralesional TAC and 5FU at a dose of 01mg TAC for every 09mg 5FU 7-10 days post-op then every 4 weeks for a total of 3 injections The mixture of TAC5FU will be prepared by the pharmacy and delivered to the physician prior to injection The goal volume of injection for both arms of the study will be 01cc per cm2 of scar excised though any deviations from this and the rationale will be noted
Assessments will be performed at 3 6 9 and 12 months after completion of treatment At each time point a member of the study team and patient will complete their respective portion of the Patient and Observer Scar Assessment Scale POSAS which has been proven as a reliable and valid method of assessing keloid scars 5 The observer portion of the survey to be completed by the study team assesses vascularity pigmentation thickness pliability and surface area of the lesion The patient portion of the survey focuses on the overall cosmetic and functional sequela including pain itching color stiffness thickness and irregularity Patients will also be asked about any side effects experienced Each portion of the POSAS will be blinded from the study team member and the participant until both have completed the survey at each visit so that one set of answers will not bias the other If a patient demonstrates signs of recurrence or return of symptoms there will be the option for additional injections within the patients originally designated study arm However if early analysis demonstrates the alternative study arm to have superior efficacy there will be the option to continue injections with the alternative study arm injection
Data collection will include demographic data such as age gender race and Fitzpatrick skin type as well as location of the keloid etiology trauma post-surgical etc and prior treatments if any The size and thickness of each lesion secondary defect size following adjacent tissue transfer and amount of adjuvant medication injected during each adjuvant injection will be collected Data analysis will include overall efficacy as well as stratification by variables such as the location of the lesion size of the lesion and prior treatment
The patients enrolled in the study will be randomized to one of two arms surgical excisionTAC or surgical excisionTAC5FU Randomization will be performed using a permuted block randomization algorithm Ex AABBABABABBABBAA where ATAC only group and BTAC 5FU All patients will undergo surgical excision of the keloid either under general anesthesia in the operating room or local anesthesia in the clinic setting depending on patient age and preference The goal of excision will be complete extra-lesional excision with primary closure It will be noted if a patient requires intra-lesional excision or additional reconstructive techniques such as advancement flap skin grafting or allografting ie Integra Monofilament sutures will be used preferentially to prevent local inflammatory reaction which can precipitate keloid formation In group 1 surgical excisionTAC all patients will be treated with adjuvant intralesional TAC 40mgmL 7-10 days post-op and then every 4 weeks for a total of 3 injections The triamcinolone vial will be obtained from pharmacy and drawn up by the physician prior to injection In group 2 surgical excisionTAC5FU all patients will be treated with adjuvant intralesional TAC and 5FU at a dose of 01mg TAC for every 09mg 5FU 7-10 days post-op then every 4 weeks for a total of 3 injections The mixture of TAC5FU will be prepared by the pharmacy and delivered to the physician prior to injection The goal volume of injection for both arms of the study will be 01cc per cm2 of scar excised though any deviations from this and the rationale will be noted
Assessments will be performed at 3 6 9 and 12 months after completion of treatment At each time point a member of the study team and patient will complete their respective portion of the Patient and Observer Scar Assessment Scale POSAS which has been proven as a reliable and valid method of assessing keloid scars 5 The observer portion of the survey to be completed by the study team assesses vascularity pigmentation thickness pliability and surface area of the lesion The patient portion of the survey focuses on the overall cosmetic and functional sequela including pain itching color stiffness thickness and irregularity Patients will also be asked about any side effects experienced Each portion of the POSAS will be blinded from the study team member and the participant until both have completed the survey at each visit so that one set of answers will not bias the other If a patient demonstrates signs of recurrence or return of symptoms there will be the option for additional injections within the patients originally designated study arm However if early analysis demonstrates the alternative study arm to have superior efficacy there will be the option to continue injections with the alternative study arm injection
Data collection will include demographic data such as age gender race and Fitzpatrick skin type as well as location of the keloid etiology trauma post-surgical etc and prior treatments if any The size and thickness of each lesion secondary defect size following adjacent tissue transfer and amount of adjuvant medication injected during each adjuvant injection will be collected Data analysis will include overall efficacy as well as stratification by variables such as the location of the lesion size of the lesion and prior treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None