What do patients think about rhomboid flap scars?
| ISRCTN | ISRCTN12112103 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12112103 |
- Submission date
- 05/12/2021
- Registration date
- 14/12/2021
- Last edited
- 06/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
The rhomboid flap is a popular reconstructive technique for skin defects. However, no study to date has explored the patient’s perceptions of this technique. The aim is to try to answer that question.
Who can participate?
An adult who has undergone rhomboid flap surgery at UPMC Hamot, Erie, PA (USA)
What does the study involve?
Patients complete an outcome questionnaire to record their views about appearance and satisfaction of the scar at one year after the procedure.
What are the possible benefits and risks of participating?
The data will help guide future patients about anticipated scars. No risk of participating. The participation is voluntary.
Where is the study run from?
University of Pittsburgh (USA)
When is the study starting and how long is it expected to run for?
April 2021 to August 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Ajaipal S Kang MD, drjaykang@gmail.com
Contact information
Public
4891 Thoroughbred loop
Erie
16506
United States of America
 ORCID ID |
0000-0001-7660-5944 |
|---|---|
| Phone | +1 (0)8147466705 |
| Kangas@upmc.edu |
Scientific
4891 Thoroughbred loop
Erie
16506
United States of America
| Phone | +1 (0)8147466705 |
|---|---|
| Kangas@upmc.edu |
Study information
| Study design | Retrospective observational case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Assessment of rhomboid flap scars: a patient-reported outcome study. A case series |
| Study hypothesis | Patients believe that the rhomboid flap scars are well-matched with their skin and are satisfied with the scars. |
| Ethics approval(s) | Approved 07/04/2021, University of Pittsburgh Institutional Review Board (Human Research Protection Office, 3500 Fifth Avenue, Main Office, Suite 106, Pittsburgh, PA 15213, USA; +1 412 383-1480, askirb@pitt.edu), ref: STUDY21030045 |
| Condition | Rhomboid scar quality |
| Intervention | The researchers studied 100 consecutive rhomboid flaps performed in 73 patients by a single surgeon. After at least 1 year from flap completion, a validated published Patient Scar Assessment Questionnaire (PSAQ) by Durani et al was completed for each of the 100 flaps. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Appearance and satisfaction scores of rhomboid scar quality measured using a questionnaire at least one year post procedure |
| Secondary outcome measures | Demographic information: age, gender, size of scar measured using patient records at least one year post procedure |
| Overall study start date | 02/02/2021 |
| Overall study end date | 01/09/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 73 |
| Participant inclusion criteria | All consecutive patients 18 years and older who underwent reconstruction of a cutaneous defect using a rhomboid flap between 01/09/2019 and 31/01/2020 by the primary author |
| Participant exclusion criteria | 1. Rhomboid flap performed in patients aged under 18 years 2. Patients with incomplete data 3. Deceased patients 4. Individuals with non-rhomboid flap method of reconstruction |
| Recruitment start date | 01/05/2021 |
| Recruitment end date | 21/08/2021 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Erie
16507
United States of America
Sponsor information
Hospital/treatment centre
201 State Street
Erie
16507
United States of America
| Phone | +1 (0)8148776000 |
|---|---|
| bianchilm@upmc.edu | |
| Website | https://www.upmc.com/locations/hospitals/hamot |
"ROR" |
https://ror.org/038fqcc39 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in the Annals of Medicine and Surgery |
| IPD sharing plan | Raw data will not be made available due to privacy. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 07/02/2022 | 06/01/2023 | Yes | No |
Editorial Notes
06/01/2023: Publication reference added.
13/12/2021: Trial's existence confirmed by University of Pittsburgh.
