Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04648267
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2020-11-14
Brief Title:
Factors Affecting Split Thickness Skin Graft Success Rates in Patients Who Underwent a Radial Forearm or Fibula Free Flap
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Factors Affecting Split Thickness Skin Graft Success Rates in Patients Who Underwent a Radial Forearm or Fibula Free Flap
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Fibula free flaps FFF and radial forearm free flaps RFFF are necessary to reconstruct parts of the face after cancer surgery traumas or debilitating infections Oftentimes after we take the flap from the arm or leg there is a large skin defect that must be filled A split thickness skin graft STSG usually from the thigh can be used to fill this defect Split thickness skin grafts get their blood supply from the underlying tissue Hence pressure must be applied to the skin grafts to ensure that they stick to the underlying tissue and are properly perfused A bolster and cast is placed onto the skin graft to apply pressure and to immobilize the skin graft to optimize healing However skin grafts still often do not take well Thus the objective of this study is to see if the duration of the cast and bolster over the skin graft has an effect on how well it integrates into the wound bed
The study will compare 2 groups the standard of care 5-7 day cast group versus the experiment 10-14 day cast group The hypothesis is that people with longer cast and bolster duration will have better healing rates Surveys will also be administered to see if cast and bolster duration will affect quality of life and self-esteem
The study will compare 2 groups the standard of care 5-7 day cast group versus the experiment 10-14 day cast group The hypothesis is that people with longer cast and bolster duration will have better healing rates Surveys will also be administered to see if cast and bolster duration will affect quality of life and self-esteem
Detailed Description:
This will be a prospective randomized control trial with a recruitment goal of 220 patients One hundred and ten 110 patients will have undergone a split thickness skin graft STSG to reconstruct the fibula free flap FFF donor site and another one hundred and ten 110 patients will be for those with a radial forearm free flap RFFF donor site This is anticipated to be a 5 year study
Patients will be recruited in clinic The study will be discussed at their pre-surgery evaluation visit and patients will be provided with a copy of the consent form to take home to discuss whether or not they wish to proceed with the study On the day of the surgery should the patients decide on joining the study they will be consented and asked to fill out pre-surgery surveys These surveys are the quality of life 36 item short form survey SF 36 and a Rosenberg self-esteem survey
Participants will be randomized to either the standard or the experimental group and this information will be placed in an opaque envelope attached to the consent Participants then undergo surgery and receive routine post-operative care as per standard of care After surgery on post operative day 1 one of the co-investigators will open the envelope which will reveal whether the participant is to have the cast and bolster for 5-7 days or 10-14 days Participants who have their casts and bolsters on for 5-7 days will have them removed before discharge and those who are assigned to the longer group will have them taken off in clinic at their first post-operative visit
At their one month follow up appointment a picture will be taken of the donor site Participants will also be asked to fill out a quality of life 36 item short form survey SF 36 and a Rosenberg self-esteem survey directly on Redcap Participants do not have to make extra trips to the physicians office These pictures and surveys will be administered at their routine office visits At 3 month the participant will receive the same surveys again by mail or email per their preference Once they have completed these surveys at 3 months they will have completed their portion of the study
The investigators will then analyze the skin graft pictures on Adobe Photoshop All of the photos of the grafts will be de-identified and the people analyzing the pictures will be blinded They will estimate the percentage of the graft that has healed well or take
Patients will be recruited in clinic The study will be discussed at their pre-surgery evaluation visit and patients will be provided with a copy of the consent form to take home to discuss whether or not they wish to proceed with the study On the day of the surgery should the patients decide on joining the study they will be consented and asked to fill out pre-surgery surveys These surveys are the quality of life 36 item short form survey SF 36 and a Rosenberg self-esteem survey
Participants will be randomized to either the standard or the experimental group and this information will be placed in an opaque envelope attached to the consent Participants then undergo surgery and receive routine post-operative care as per standard of care After surgery on post operative day 1 one of the co-investigators will open the envelope which will reveal whether the participant is to have the cast and bolster for 5-7 days or 10-14 days Participants who have their casts and bolsters on for 5-7 days will have them removed before discharge and those who are assigned to the longer group will have them taken off in clinic at their first post-operative visit
At their one month follow up appointment a picture will be taken of the donor site Participants will also be asked to fill out a quality of life 36 item short form survey SF 36 and a Rosenberg self-esteem survey directly on Redcap Participants do not have to make extra trips to the physicians office These pictures and surveys will be administered at their routine office visits At 3 month the participant will receive the same surveys again by mail or email per their preference Once they have completed these surveys at 3 months they will have completed their portion of the study
The investigators will then analyze the skin graft pictures on Adobe Photoshop All of the photos of the grafts will be de-identified and the people analyzing the pictures will be blinded They will estimate the percentage of the graft that has healed well or take
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?:
None
Is an FDA AA801 Violation?:
None