NCT00600457

Brief Summary

The purpose of this study is to determine whether the combination of modified polyurethane film and secondary absorbent dressing for skin graft donor sites avoids the regular uncontrolled leakage, but holds up the advantages of film dressings for this kind of wound.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
Last Updated

December 16, 2008

Status Verified

December 1, 2008

Enrollment Period

5 months

First QC Date

January 23, 2008

Last Update Submit

December 15, 2008

Conditions

Wound Healing

Keywords

healing timepaininfection

Outcome Measures

Primary Outcomes (1)

  • uncontrolled leakage

    1-10th day postoperative

Secondary Outcomes (3)

  • pain

    1-10th day postoperative

  • infection

    1-10th day postoperative

  • epithelization status

    10th day postoperative

Study Arms (1)

A,1

Device: Polyurethane Film

Interventions

Polyurethane FilmDEVICE

The modified polyurethane film is combined with a secondary absorbent dressing and remained intact until the 10th postoperative day

A,1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults over age 18 who require skin grafting

You may not qualify if:

  • Individuals under the age of 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich Bogenhausen, Technical University Munich

Munich, Germany

Location

Related Publications (4)

  • Birdsell DC, Hein KS, Lindsay RL. The theoretically ideal donor site dressing. Ann Plast Surg. 1979 Jun;2(6):535-7. doi: 10.1097/00000637-197906000-00015.

    PMID: 396845BACKGROUND

  • James JH, Watson AC. The use of Opsite, a vapour permeable dressing, on skin graft donor sites. Br J Plast Surg. 1975 Apr;28(2):107-10.

    PMID: 1098708BACKGROUND

  • Ramirez OM, Granick MS, Futrell JW. Optimal wound healing under Op-Site dressing. Plast Reconstr Surg. 1984 Mar;73(3):474-5. doi: 10.1097/00006534-198403000-00028.

    PMID: 6701224BACKGROUND

  • Barnea Y, Amir A, Leshem D, Zaretski A, Weiss J, Shafir R, Gur E. Clinical comparative study of aquacel and paraffin gauze dressing for split-skin donor site treatment. Ann Plast Surg. 2004 Aug;53(2):132-6. doi: 10.1097/01.sap.0000112349.42549.b3.

    PMID: 15269581BACKGROUND

MeSH Terms

Conditions

PainInfections

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ulf Dornseifer, MD

    Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich-Bogenhausen, Technical University Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 23, 2008

First Posted

January 25, 2008

Study Start

March 1, 2007

Primary Completion

August 1, 2007

Study Completion

September 1, 2007

Last Updated

December 16, 2008

Record last verified: 2008-12

Locations

DE(1)