Trial Outcomes & Findings for ObservAtional Study to Investigate Surgical Site Infection in Ulcerated Skin Cancers (NCT NCT03782727)
NCT ID: NCT03782727
Last Updated: 2023-12-21
Results Overview
Percentage of participants with surgical site infection (SSI) identified by online/ postal questionnaire (Bluebelle Wound Healing Questionnaire) four weeks after surgery.
COMPLETED
148 participants
Four weeks after surgery.
2023-12-21
Participant Flow
Participant milestones
| Measure |
Participants Consented
Consecutive adult patients aged 18 years old or older who presented at either centre's outpatient department for an ulcerated skin cancer excision of any type in any body site were invited to participate.
|
|---|---|
|
Overall Study
STARTED
|
148
|
|
Overall Study
COMPLETED
|
116
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
Participants Consented
Consecutive adult patients aged 18 years old or older who presented at either centre's outpatient department for an ulcerated skin cancer excision of any type in any body site were invited to participate.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
32
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Overall
n=148 Participants
Adult patients undergoing surgical excision of ulcerated skin cancer under local anaesthetic.
|
|---|---|
|
Age, Continuous
|
77.1 years
STANDARD_DEVIATION 12.3 • n=148 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
105 Participants
n=148 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
41 Participants
n=148 Participants
|
|
Sex/Gender, Customized
Gender · Missing data
|
2 Participants
n=148 Participants
|
|
Region of Enrollment
United Kingdom
|
148 Participants
n=148 Participants
|
PRIMARY outcome
Timeframe: Four weeks after surgery.Population: Proportion of participants with surgical site infection (SSI) identified by postal questionnaire (Bluebelle Wound Healing Questionnaire) four weeks after surgery (with score of 8 and above).
Percentage of participants with surgical site infection (SSI) identified by online/ postal questionnaire (Bluebelle Wound Healing Questionnaire) four weeks after surgery.
Outcome measures
| Measure |
Participants Consented
n=116 Participants
Consecutive adult patients aged 18 years old or older who presented at either centre's outpatient department for an ulcerated skin cancer excision of any type in any body site were invited to participate.
|
|---|---|
|
To Ascertain the Percentage of Surgical Site Infections Following Excision of Ulcerated Skin Tumours in Dermatology Departments.
|
35 Participants
|
Adverse Events
Participants Consented
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Rachel Abbott
Cardiff and Vale University Health Board
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place