Clinical trial NCT00392301: Split-Thickness Skin Graft Donor Site Wound Healing Study
Official title: Split-Thickness Skin Graft Donor Site Wound Healing Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Split-thickness Skin Graft Donor Sites
Keywords: wound healing
skin
graft donor site
donor site
transepidermal water loss
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2006-10-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with split thickness skin graft donor sites

Brief summary: The purpose of this research study is to discover whether instruments widely used in skin research can be used to measure wound healing in split thickness skin graft donor sites and whether these instruments can detect differences in healing when two different dressing products are used.

Detailed description: Currently there is no standard treatment to promote wound healing for split thickness skin graft donor sites and healing is determined based on clinical observation of the graft donor site and clinical judgement. Here we propose to use two instruments commonly used in skin research to measure wound healing. This study will validate the use of these two instruments, one that measures transepidermal water loss and the other that measures skin pigmentation to determine healing. To further validate the use of these instruments we will determine if these instruments can detect differences between two different wound dressing products that have been previously reported to heal skin graft donor sites at different rates.

Eligibility criteria: Inclusion Criteria:

* Participants 18 years of age and over who have a split-thickness skin graft donor site.

Exclusion Criteria:

* Individuals under 18 years of age.
* Individuals who do not have a split thickness skin graft donor site.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Annette B. Wysocki, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Disa JJ, Alizadeh K, Smith JW, Hu Q, Cordeiro PG. Evaluation of a combined calcium sodium alginate and bio-occlusive membrane dressing in the management of split-thickness skin graft donor sites. Ann Plast Surg. 2001 Apr;46(4):405-8. doi: 10.1097/00000637-200104000-00009.
citation: Feldman DL, Rogers A, Karpinski RH. A prospective trial comparing Biobrane, Duoderm and xeroform for skin graft donor sites. Surg Gynecol Obstet. 1991 Jul;173(1):1-5.
citation: Feldman DL. Which dressing for split-thickness skin graft donor sites? Ann Plast Surg. 1991 Sep;27(3):288-91. doi: 10.1097/00000637-199109000-00017.
citation: Kilinc H, Sensoz O, Ozdemir R, Unlu RE, Baran C. Which dressing for split-thickness skin graft donor sites? Ann Plast Surg. 2001 Apr;46(4):409-14. doi: 10.1097/00000637-200104000-00010.
citation: Malpass KG, Snelling CF, Tron V. Comparison of donor-site healing under Xeroform and Jelonet dressings: unexpected findings. Plast Reconstr Surg. 2003 Aug;112(2):430-9. doi: 10.1097/01.PRS.0000070408.33700.C7.
citation: Rakel BA, Bermel MA, Abbott LI, Baumler SK, Burger MR, Dawson CJ, Heinle JA, Ocheltree IM. Split-thickness skin graft donor site care: a quantitative synthesis of the research. Appl Nurs Res. 1998 Nov;11(4):174-82. doi: 10.1016/s0897-1897(98)80296-6.