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Lipomodelling for Symptomatic Peri-stomal Skin Contour Abnormalities: a Pilot and Feasibility Study

NCT02090985 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-03-19

No results posted yet for this study

Summary

In this study a technique called 'lipomodelling' is being studied to find out if it is beneficial around the stoma site in patients who have difficulty with securing their stoma bags which may lead to leakage and frequent soiling which we believe reduces quality of life.

Patients with colostomy (stoma formed by bringing large bowel to the surface of the abdomen), ileostomy (small bowel) or a urostomy (urinary tract) will be recruited into this study.

Lipomodelling is a technique that is commonly used elsewhere in the body but to our knowledge has not been used for this purpose. This study is a pilot study that may lead to further research in this area.

Lipomodelling means taking some of your own fat that lies just beneath the surface of the skin and transferring it to another part of your body. The fat is removed by suction (liposuction), normally from your thighs or abdomen. In order to use the most important part of the fat, it is then put into a machine called a centrifuge. This spins the fat so that it splits up into three different sections. The most important section is then separated and injected in very small quantities into the required areas around your stoma. It is thought to have cells that encourage rejuvenation as well as helping to fill the area injected.

Peri-stomal means the area around the stoma itself, this includes skin and underlying tissue, which will be fat and scar tissue. After any operation there will be scarring that takes some time to fully develop. Usually after a year the scar tissue will be fully formed. The scar tissue may cause the skin around the stoma to be irregular. This is described as contouring of the skin.

The aim of this study is to see if lipomodelling can improve your quality of life by reducing the frequency of changing your stoma bag, reduce leakage and the need for extra-stomal appliances to try and help the stoma bag fit to your body securely.

Conditions

  • Stoma

Interventions

PROCEDURE

Lipomodelling of symptomatic peri-stomal skin contour abnormalities

Sponsors & Collaborators

  • Western Sussex Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Bonomi · Western Sussex Hospitals NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-12-31
Completion
2015-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02090985 on ClinicalTrials.gov