Neoplasm MetastasisNCT02408835
Negative Pressure Wound Therapy in Groin Dissection
A study testing PICO™ in people with Neoplasm Metastasis and Secondary Malignant Neoplasm of Lymph Node, run by South Eastern Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
This study investigates the use of a negative pressure wound therapy device (PICO™, Smith \& Nephew Healthcare, UK) on clean, closed surgical wounds, in patients who are undergoing inguinal lymphadenectomy for metastatic carcinoma of cutaneous origin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis, Secondary Malignant Neoplasm of Lymph Node, Non-healing Surgical Wound (Disorder)
- What is being tested?
- PICO™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically- or cytologically-proven inguinal lymph node metastases from neoplasm of cutaneous origin
Who cannot join
- inability to give informed consent for participation
Trial locations and contacts
1 site in 1 country.
Christopher Hill, MB contact
United Kingdom1 site
The Ulster Hospital
Belfast, Northern Ireland, BT16 1RH
Sandra E McAllister, MD, +442890484511, s.mcallister@qub.ac.uk
Christopher Hill, MB
About this study
Official title: A Randomised Controlled Trial Comparing PICO™ Single Use Negative Pressure Wound Therapy System (Smith & Nephew Healthcare Limited, UK) to Conventional Wound Care Following Inguinal Lymphadenectomy for Metastatic Cutaneous Malignancy
This study investigates the use of a negative pressure wound therapy device (PICO™, Smith \& Nephew Healthcare, UK) on clean, closed surgical wounds, in patients who are undergoing inguinal lymphadenectomy for metastatic carcinoma of cutaneous origin.
Read the detailed description
Patients may develop inguinal lymph node metastases from a variety of cutaneous neoplasms. A number of factors conspire to cause a high rate of wound breakdown and other complications in this patient group. Reported rates of wound healing complications vary in the literature, but tend to affect > 40% of patients.
A new negative pressure wound therapy device is recommended for use in clean, closed surgical wounds (PICO™ system, Smith \& Nephew Healthcare, UK). Patients will be randomised to receive either PICO™ system for up to seven days, or conventional dressings, and then assessed for wound healing and other outcome measures.
- Conditions
- Neoplasm Metastasis, Secondary Malignant Neoplasm of Lymph Node, Non-healing Surgical Wound (Disorder), Skin Neoplasms
- Being tested
- PICO™
- Keywords
- negative pressure wound therapy, lymphadenectomy, wound healing
- Medical subject headings
- Neoplasm Metastasis, Lymphatic Metastasis, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICO™Device
Also called PICO™, Smith & Nephew Healthcare, UK
Negative pressure wound therapy device for closed surgical wounds.
| Study group | Role | What they receive |
|---|---|---|
| PICO™ | Active comparator | Use of PICO™ system negative pressure wound therapy device on surgical wound for up to seven days. Receives: Device: PICO™ |
| Conventional wound care | No intervention | Usual wound dressings will be used as comparison group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to wound healing
Determination of wound healing
Measured: From date of surgery until epithelial integrity is restored at the surgical site. Assessed at least weekly until wound is healed, up to 20 weeks after surgery
Secondary outcomes (5)
Wound infection As defined by Comprehensive Complication Index (CCI)
As defined by Comprehensive Complication Index (CCI)
Measured: From date of surgery until wound is healed (epithelial integrity restored at surgical site), up to 20 weeks after surgery.
Lymphoedema (Limb volume measurements)
Limb volume measurements at 3, 6, 9 and 12 months
Measured: From date of surgery up to one year post-operatively.
Need for further surgical interventions to achieve wound healing
Measured: From date of surgery until wound is healed, up to 20 weeks after surgery.
Scar appearance (POSAS)
POSAS at 3,6, 9 and 12 months
Measured: From date of surgery up to one year post-operatively.
Patient reported outcomes (qualitative interview)
Semi-structured qualitative interviews in first week after surgery, and at 6 months after surgery.
Measured: From date of surgery to six months post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Eastern Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra McAllister, South Eastern Health and Social Care Trust
- Investigators
- Christopher Hill, MB, Study chair, South Eastern Health & Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408835
- Sponsor's protocol ID
- NPWT/14/1.0
- Status last verified
- Apr 2015
- First submitted
- 19 Dec 2014
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing PICO™ Single Use Negative Pressure Wound Therapy System (Smith & Nephew Healthcare Limited, UK) to Conventional Wound Care Following Inguinal Lymphadenectomy for Metastatic Cutaneous Malignancy
- ClinicalTrials.gov ID
- NCT02408835
- Acronym / sponsor ID
- NPWT/14/1.0
- Conditions
- Neoplasm Metastasis, Secondary Malignant Neoplasm of Lymph Node, Non-healing Surgical Wound (Disorder), Skin Neoplasms
- Keywords
- negative pressure wound therapy, lymphadenectomy, wound healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- South Eastern Health and Social Care TrustUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 6 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the use of a negative pressure wound therapy device (PICO™, Smith \& Nephew Healthcare, UK) on clean, closed surgical wounds, in patients who are undergoing inguinal lymphadenectomy for metastatic carcinoma of cutaneous origin.
Detailed description
Patients may develop inguinal lymph node metastases from a variety of cutaneous neoplasms. A number of factors conspire to cause a high rate of wound breakdown and other complications in this patient group. Reported rates of wound healing complications vary in the literature, but tend to affect > 40% of patients.
A new negative pressure wound therapy device is recommended for use in clean, closed surgical wounds (PICO™ system, Smith \& Nephew Healthcare, UK). Patients will be randomised to receive either PICO™ system for up to seven days, or conventional dressings, and then assessed for wound healing and other outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICO™ | Active comparator | Device: PICO™Use of PICO™ system negative pressure wound therapy device on surgical wound for up to seven days. |
| Conventional wound care | No intervention | –Usual wound dressings will be used as comparison group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically- or cytologically-proven inguinal lymph node metastases from neoplasm of cutaneous origin
Key exclusion criteria (1 listed)
- inability to give informed consent for participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICO™Also: PICO™, Smith & Nephew Healthcare, UKNegative pressure wound therapy device for closed surgical wounds. | Device | PICO™ |
Primary outcome
Time to wound healing
Time frame: From date of surgery until epithelial integrity is restored at the surgical site. Assessed at least weekly until wound is healed, up to 20 weeks after surgery
Determination of wound healing
5 secondary outcomes
Wound infection As defined by Comprehensive Complication Index (CCI)
Time frame: From date of surgery until wound is healed (epithelial integrity restored at surgical site), up to 20 weeks after surgery.
Lymphoedema (Limb volume measurements)
Time frame: From date of surgery up to one year post-operatively.
Need for further surgical interventions to achieve wound healing
Time frame: From date of surgery until wound is healed, up to 20 weeks after surgery.
Scar appearance (POSAS)
Time frame: From date of surgery up to one year post-operatively.
Patient reported outcomes (qualitative interview)
Time frame: From date of surgery to six months post-operatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
Related trials for Neoplasm Metastasis
RecruitingPhase 1/2
A Study to Investigate ALE.P02 as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Selected CLDN1+ Solid Tumors
Squamous Non-small-cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
Not yet recruitingPhase 2/3
Master Protocol for the Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC
Cachexia; Cancer, Cachexia
Active, not recruitingPhase 2
Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer
PSA Level Greater Than Two, Stage IV Prostate Adenocarcinoma AJCC v7
Active, not recruitingPhase 1/2
Safety and Efficacy of Allogeneic HPV-specific T Cells in Adults With Recurrent or Metastatic HPV16+ Cancers
HPV 16+ Recurrent or Metastatic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Hill, MB contact
Christopher Hill, MB study chair
South Eastern Health & Social Care Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICO™ in people with Neoplasm Metastasis and Secondary Malignant Neoplasm of Lymph Node, run by South Eastern Health and Social Care Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra E McAllister, MD (02890484511, s.mcallister@qub.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to wound healing (time frame: From date of surgery until epithelial integrity is restored at the surgical site. Assessed at least weekly until wound is healed, up to 20 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2015.