Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts

Deep Partial Thickness Burn Clinical Trial

Official title:

Open, Prospective, Randomised Investigation Evaluating Pain With the Use of Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365273
• Other study ID #: MPTO 04
• Status: Completed
• Phase: Phase 4
• First received: May 27, 2011
• Last updated: January 17, 2014
• Start date: February 2011
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This investigation is an open, randomised investigation. Approximately 40 subjects in 4-5 centres in the US with deep-partial of full thickness burns in need of skin grafts will be enrolled.The subjects will be equally randomised to either treatment with Mepitel One or bridal veil together with staples.

The primary objective is to compare pain at the time of dressing change for the use of Mepitel One versus bridal veil together with staples on deep partial or full thickness burns requiring skin grafts.

Description:

Skin grafts are placed over excised areas of full thickness injuries and usually attached with sutures or staples. While useful in anchoring the graft in place, subjects often complain of pain from the staples as wound healing progresses.Pulling and sticking are common complaints.There is also a possibility that staples become embedded in the graft which leads to disruption of otherwise healed area, increased pain and anxiety for the subject as well as anxiety for the staff.

Graft take can be optimized with appropriate medical management. Use of non-adherent dressings to protect the graft is customary. Various types of netting-style are used, such as Bridal veil, a sterile product which is fixed over the graft with staples.

Silicone net dressings have also been used successfully to prevent lifting and adherence of skin grafts to the dressings, prevent pain and promote healing. Mepitel One is a sterile, transparent, and flexible wound contact layer consisting of perforated polyurethane film coated with Safetac soft silicone adhesive on one side. Mepitel One is available in various sizes and can be left in place for several days depending on the wound/skin condition.

Evaluation of burns will be performed at Baseline. Skin graft assessment will be performed at Day 7 and Day 14. End of study will be considered the time that graft is considered to have >95% take.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Inclusion Criteria

1. Subjects presenting with 1% - 25% Total Body Surface Area (TBSA) deep partial or full-thickness burns requiring skin graft

2. At least 1%-10% TBSA is available for grafting that can be considered for study site selection (must have intact, healthy peri-wound area around entire portion of this burned site)

3. Both genders with age =18 years but < 70 years

4. Signed informed consent

Exclusion Criteria:

1. Subjects with chronic wounds

2. Subjects who are on mechanical ventilation

3. Subjects with dermatologic skin conditions or necrotizing disorders

4. Diagnosed underlying disease(s) (HIV/AIDS, cancer and severe anaemia)judged by the investigator to be a potential interference in the treatment

5. Subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10 mg prednisolon/day or equivalent

6. Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days

7. Known allergy/hypersensitivity to any of the components of the investigational products

8. Subjects with physical and/or mental conditions that are not expected to comply with the investigation

9. Participation in other clinical investigation(s) within 1 month prior to start of the investigation

10. Previously randomised to this investigation

11. Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep Partial Thickness Burn
• Full Thickness Burns

Intervention

Device:
• Mepitel One
Dressing

Locations

Country	Name	City	State
United States	Joseph M. Still Research Foundation, Inc.	Augusta	Georgia
United States	5028 Delp Bldg, Mail stop 1011	Kansas City	Kansas
United States	University Foundation for Education & Research, Inc	Tampa	Florida
United States	Natham Speare Regional Burn Treatment Ctr., Crozer Chester Medical Center	Upland	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS Score for Pain Before Dressing Removal	Pain was measured with Visual Analogue Scale (VAS)(100 mm) measuring from 0 = "no pain" at one end to 100 = "most intense pain imagaginable" at the other end.	At visit 6, day 7	Yes
Primary	VAS Score for Pain During Dressing Removal	Pain when half of the study product(s) has been removed measued with Visual Analogue Scale (VAS).0 = "no pain" till 100 = "worst pain".	Visit 6, day 7	Yes
Primary	VAS Score for Pain After Dressing Removal	Pain after the dressing removal measued with Visual Analogue Scale (VAS).0 = "no pain" till 100 = "worst pain".	Visit 6, day 7	Yes