An observational study of medical and surgical treatments for hidradenitis suppurativa

ISRCTN	ISRCTN69985145
DOI	https://doi.org/10.1186/ISRCTN69985145
Integrated Research Application System (IRAS)	266172
Protocol serial number	HTA 17/98/01, SPON 1734-19, IRAS 266172
Sponsor	Cardiff University
Funder	Health Technology Assessment Programme

Submission date: 01/08/2019
Registration date: 09/08/2019
Last edited: 01/03/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Hidradenitis suppurativa (HS) is a long term, painful skin condition. It involves boils in areas such as the armpit and groin. It affects young adults of working age. HS has a big effect on quality of life due to pain, scarring and release of pus. It also affects sex and relationships. This study will provide vital information to answer questions that were identified as priority areas for research by patients with HS and the doctors and nurses who treat them. The aim is to inform the design of future HS trials and to understand how HS treatments are currently used. This involves five steps:
1. Describe the treatments used around the country (particularly the type of operation, which can vary from centre to centre)
2. See whether patients might consider joining a research study in the future and which treatment(s) they would prefer
3. Define how patients with HS are currently seen within the health service. Learn what influences patients’ and clinicians’ treatment choices
4. Select the best ways of measuring response to treatment (outcome measures)
5. Ask patients and doctors to agree the best design for future HS studies

Who can participate?
Patients aged 18 years and over with active HS of any severity that is not adequately controlled by current treatment

What does the study involve?
Patients with HS are invited to join the study as volunteers. By inviting people who are treated by skin doctors and those treated by surgeons, the researchers should receive information about a range of treatments. The volunteers pick from the range of treatments available locally and, for the year after, the researchers record what happens to them. They measure how well the treatment has worked using recommended questionnaires and help to interpret the questionnaire results by checking what changes in score matter to patients and whether the questionnaires are suitable for normal clinical practice. During the study the surgical and laser operations are video recorded to make a training video for future studies.

What are the possible benefits and risks of participating?
Deroofing and laser hair removal, when offered by a recruiting centre, are not usually available for HS in the UK (they are available in several other countries). Participants will also be contributing to standardising outcome measures for future HS trials. Techniques used for surgical procedures are part of standard surgical skills, but all participating surgeons will complete a specialised training package before performing deroofing. Participation in the study will require completion of some additional questionnaires not currently used in routine HS care that will take up additional time during clinic appointments.

Where is the study run from?
1. University Hospital of Wales
2. Hull York Medical School
3. Royal Free Hospital
4. Newcastle Upon Tyne Hospital
5. Broomfield Hospital
6. Guy's & St Thomas Hospitals
7. Barnsley Hospital
8. Stirling Community Hospital
9. Salisbury Hospital
10. Nuffield Orthopaedic Centre

When is the study starting and how long is it expected to run for?
April 2019 to March 2022

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
1. Janine Bates
batesmj@cardiff.ac.uk
2. Dr John Ingram
ingramjr@cardiff.ac.uk

Contact information

Ms Janine Bates
Public

Centre for Trials Research
College of Biomedical and Life Sciences
Cardiff University
7th Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom

Phone	+44 (0)29 20687616
Email	batesmj@cardiff.ac.uk

Dr John Ingram
Scientific

Division of Infection & Immunity
Cardiff University
Cardiff
CF10 4AT
United Kingdom

Phone	+44 (0)29 2074 2190
Email	ingramjr@cardiff.ac.uk

Study information

Primary study design	Observational
Study design	Prospective cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Treatment of hidradenitis suppurativa evaluation study (THESEUS)
Study acronym	THESEUS
Study objectives	To inform the design of future HS RCTs and to understand how HS treatments are currently used.
Ethics approval(s)	Approved 26/09/2019, Wales Research Ethics Committee 4 Wrexham (Health and Care Research Wales Support Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)7976 982591; Wales.REC4@wales.nhs.uk), REC ref: 19/WA/0263
Health condition(s) or problem(s) studied	Hidradenitis suppurativa
Intervention	1. Oral doxycycline 200 mg OD for 6 months initially 2. Oral clindamycin and rifampicin both 300 mg BD as a combined course for 10 weeks 3. Laser treatment 4. Deroofing of sinus tracts 5. Conventional surgery (narrow or wide excision, with a range of closure methods) Participants choose their preferred treatment intervention and have follow ups every three months up to 12 months. They can swap treatment intervention during this time, should they wish to do so.
Intervention type	Mixed
Primary outcome measure(s)	Proportion of participants who are eligible, and hypothetically willing, to use the different treatment options, measured using screening log at baseline
Key secondary outcome measure(s)	1. Proportion of participants choosing each of the study interventions, with reasons for their choices, measured using descriptive statistics of each group membership for each intervention at baseline/month 0 2. Proportion of participants who switch treatments during the study follow-up period, with reasons for switch, measured using questionnaires during the study follow-up period 3. Treatment fidelity measured using questionnaire at 3, 6, 9 and 12 months 4. Loss to follow-up rates measured using percentage of consented participants failing to attend appointments over 12 months 5. Efficacy outcome estimates after 6 months’ of follow up to inform outcome measure instruments’ responsiveness (minimum important difference, MID): 5.1. Pain measured using a numeric rating scale at the baseline appointment and then on a daily basis for the first 12 weeks following treatment commencement via mobile telephone text message 5.2. HS-specific quality of life measured using HiSQOL 5.3. Global assessment (average change over time estimation) 5.4. Progression of course (flare frequency) (average change over time estimation) 5.5. Physical signs (average change over time estimation) 5.6. Symptoms (drainage resulting in need for dressings and fatigue) (average change over time estimation) 5.7. Generic quality of life measured using EQ-5D The researchers will report completeness of each outcome at each timepoint (0, 3, 6, 9 and 12 months)
Completion date	31/03/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	150
Total final enrolment	151
Key inclusion criteria	1. Adults at least 18 years old with active HS of any severity 2. Diagnosis confirmed by recruiting clinician with experience of HS care 3. HS not adequately controlled by current treatment 4. At least one of the five study interventions is appropriate for participant’s care
Key exclusion criteria	1. Unable or unwilling to give informed consent 2. Pregnancy or breastfeeding
Date of first enrolment	18/02/2020
Date of final enrolment	28/07/2021

Locations

Countries of recruitment

United Kingdom
England
Scotland
Wales

Study participating centres

University Hospital of Wales

Heath Park Way
Cardiff
CF14 4XW
United Kingdom

Newcastle Upon Tyne Hospital

Clayton Road
Newcastle Upon Tyne
NE2 1JP
United Kingdom

Broomfield Hospital

Court Road
Chelmsford
CM1 7ET
United Kingdom

Guys & St Thomas Hospitals

Great Maze Pond
London
SE1 9RT
United Kingdom

Barnsley Hospital

Gawber Road
Barnsley
S75 2EP
United Kingdom

Stirling Community Hospital

Livilands Gate
Stirling
FK8 2AU
United Kingdom

Nuffield Orthopaedic Centre

Windmill Road
Headington
Oxford
OX3 7HE
United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford
OX3 7HE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	The datasets generated and/or analysed during the current study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		12/10/2023	16/10/2023	Yes	No
Results article		01/12/2023	28/12/2023	Yes	No
Protocol article		21/04/2022	25/04/2022	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version V1.0	25/07/2019	09/08/2019	No	No

Additional files

ISRCTN69985145_PROTOCOL_V1.0_25July2019.pdf: Uploaded 09/08/2019

Editorial Notes

01/03/2024: The following changes were made to the study record:
1. The recruitment start date was changed from 01/10/2019 to 18/02/2020.
2. The recruitment end date was changed from 30/06/2021 to 28/07/2021.
3. The study participating centres were updated to remove Hull York Medical School, Royal Free Hospital and Salisbury Hospital and add Oxford University Hospitals NHS Foundation Trust.
4. The intention to publish date was changed from 31/07/2022 to 20/12/2023.
5. The total final enrolment was changed from 150 to 151.
28/12/2023: Publication reference added.
16/10/2023: Publication reference and total final enrolment added.
25/04/2022: Publication reference added.
09/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2021 to 30/06/2021.
2. The intention to publish date was changed from 01/03/2022 to 31/07/2022.
18/09/2020: The recruitment end date has been changed from 30/09/2020 to 31/03/2021.
29/07/2020: Ethics approval details added.
09/08/2019: Uploaded protocol Version 1.0, 25 July 2019 (not peer reviewed).
01/08/2019: Trial's existence confirmed by the NIHR.