- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02408835
Negative Pressure Wound Therapy in Groin Dissection
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sandra E McAllister, MD
- Phone Number: 02890484511
- Email: s.mcallister@qub.ac.uk
Study Contact Backup
- Name: Christopher Hill, MB
- Phone Number: 02890484511
Study Locations
-
-
Northern Ireland
-
Belfast, Northern Ireland, United Kingdom, BT16 1RH
- The Ulster Hospital
-
Contact:
- Sandra E McAllister, MD
- Phone Number: +442890484511
- Email: s.mcallister@qub.ac.uk
-
Principal Investigator:
- Christopher Hill, MB
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically- or cytologically-proven inguinal lymph node metastases from neoplasm of cutaneous origin
Exclusion Criteria:
- inability to give informed consent for participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PICO™
Use of PICO™ system negative pressure wound therapy device on surgical wound for up to seven days.
|
Negative pressure wound therapy device for closed surgical wounds.
Other Names:
|
No Intervention: Conventional wound care
Usual wound dressings will be used as comparison group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
As defined by Comprehensive Complication Index (CCI)
|
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.
|
Limb volume measurements at 3, 6, 9 and 12 months
|
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.
|
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.
|
POSAS at 3,6, 9 and 12 months
|
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.
|
Semi-structured qualitative interviews in first week after surgery, and at 6 months after surgery.
|
From date of surgery to six months post-operatively.
|
Collaborators and Investigators
Investigators
- Study Chair: Christopher Hill, MB, South Eastern Health & Social Care Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NPWT/14/1.0
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neoplasm Metastasis
-
Betta Pharmaceuticals Co., Ltd.Recruiting
-
BayerCompleted
-
BayerCompletedNeoplasm Metastasis / Bone and BonesBelgium, Spain, Taiwan, United States, Japan, Russian Federation, Canada, Finland, Korea, Republic of, Singapore, Australia, Germany, Israel, United Kingdom, Italy, France, Poland, Brazil, Czechia, Norway, Sweden, Hong Kong
-
National Cancer Institute (NCI)TerminatedCancer | Neoplasm Metastasis | Metastasis | Neoplasm | Radiation OncologyUnited States
-
MedtronicNeuroCompletedMetastasis Spine | Metastasis to BoneUnited States, Luxembourg, Germany, France, Canada
-
Cho Ray HospitalUniversity of Medicine and Pharmacy at Ho Chi Minh CityRecruitingSynchronous Neoplasm | Liver Metastasis Colon CancerVietnam
-
Li MinRecruiting
-
Da FuGanzhou City People's HospitalRecruiting
-
University of Mississippi Medical CenterCompletedMetastasisUnited States
-
Assiut UniversityNot yet recruiting
Clinical Trials on PICO™
-
Istituto Clinico HumanitasSmith & Nephew, Inc.RecruitingStoma Site InfectionItaly
-
St James Connolly Memorial HospitalUnknownWound Infection | Wound ComplicationIreland
-
Robert Jones and Agnes Hunt Orthopaedic and District...Smith & Nephew, Inc.Recruiting
-
North Middlesex University Hospital NHS TrustNot yet recruiting
-
University of ArizonaCompletedHigh Risk Pregnancy | Cesarean Wound Disruption With Postnatal ComplicationUnited States
-
Northwell HealthCompletedCesarean Section Complications | Cesarean Wound Disruption | Cesarean Wound; DehiscenceUnited States
-
Smith & Nephew, Inc.CompletedDelayed HealingUnited States, South Africa, France, Netherlands
-
Goldman, Butterwick, Fitzpatrick and GroffNot yet recruitingSkin Quality
-
Cedars-Sinai Medical CenterNational Cancer Institute (NCI)RecruitingGastrointestinal Neoplasms | Stomach Cancer | Small Intestine Cancer | Rectal Cancer | Neuroendocrine Tumor | Bile Duct Cancer | Colon Cancer | Pancreas Cancer | Anal Cancer | Liver Cancer | Biliary Tract Cancer | Peritoneal Cancer | Carcinoid Tumor | Gallbladder Cancer | Cancer Pain | Carcinoid Tumor of the Small Bowel | Visceral... and other conditionsUnited States
-
J.C. GoslingsCompletedNegative Pressure Wound Therapy | Vacuum Therapy | Closed IncisionsNetherlands