NCT01773694

Brief Summary

Patients are often counseled to keep a surgical wound dry for 2 to 3 days. The rationale is likely to decrease the risk of infection and bleeding. However, this has never been formally studied. Patient's routines are likely disrupted when they are asked to avoid wetting the area. The investigators will perform a controlled study to determine if avoidance of post-operative wetting is necessary.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
507

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

January 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2020

Completed
Last Updated

November 1, 2021

Status Verified

September 1, 2020

Enrollment Period

7 years

First QC Date

January 18, 2013

Last Update Submit

October 28, 2021

Conditions

Surgical Wound Infection

Keywords

Post-operative managementPost-operative complicationsPost-operative treatmentwaterskinDermatologic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • Post-operative wound infection

    Post-operative day 7 to 14

Secondary Outcomes (3)

  • Incidence of post-operative bleeding complications

    Post-operative day 7 to 14

  • Scar appearance

    6 months post-operatively (+-5 days)

  • Skin Specific Quality of Life

    Post-operative days 7 to14

Study Arms (2)

Early Water Exposure

ACTIVE COMPARATOR

The Intervention group will receive written and verbal instructions to remove the dressing after 6 hours and wet the wound for at least 10 minutes. Wetting of the wound will include shower, tub bath, or pool exposure.

Behavioral: Early Water Exposure

Standard Care

NO INTERVENTION

The Standard Care group will receive standard wound care instructions and verbal education by the staff to keep the dressing dry and intact for 48 hours.

Interventions

Early Water ExposureBEHAVIORAL

The Early Water Exposure (Intervention) group will receive written and verbal instructions to remove the dressing after 6 hours and wet the wound for at least 10 minutes. Wetting of the wound will include shower, tub bath, or pool exposure. On subsequent days, all participants, regardless of group assignment, will wash the wound daily with soap and water, reapply white petrolatum and a dry dressing.

Early Water Exposure

Eligibility Criteria

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

You may qualify if:

  • subjects are capable of giving informed consent
  • patients undergoing any surgical treatment of benign and malignant lesions by any physician in the Dermatology department consisting of:
  • standard excisional surgery or Mohs micrographic surgery with immediate reconstruction
  • reconstruction with primary linear closure or adjacent tissue transfer with one or two layers of suture

You may not qualify if:

  • pregnancy
  • age younger than 18 years
  • will not be returning to the dermatology clinic in 7-14 days for suture removal
  • documented or suspected infection of the site prior to surgery
  • current treatment with systemic antibiotic therapy
  • staged excisions
  • delayed or staged reconstructions
  • wounds repaired with skin or cartilage grafts
  • management with secondary intention healing
  • surgical site on or near a mucosal surface where standard dressings are not typically used (eyelid, vermilion, etc.)
  • patients receiving prophylactic antibiotics
  • patients deemed on a case-by-case basis by their surgeon to have a high risk of post-operative bleeding and requiring prolonged application of a pressure dressing
  • history of skin sensitivity or reaction to white petrolatum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (12)

  • Mudigonda T, Pearce DJ, Yentzer BA, Williford P, Feldman SR. The economic impact of non-melanoma skin cancer: a review. J Natl Compr Canc Netw. 2010 Aug;8(8):888-96. doi: 10.6004/jnccn.2010.0066.

    PMID: 20870635BACKGROUND

  • Li J, Chen J, Kirsner R. Pathophysiology of acute wound healing. Clin Dermatol. 2007 Jan-Feb;25(1):9-18. doi: 10.1016/j.clindermatol.2006.09.007.

    PMID: 17276196BACKGROUND

  • Menke NB, Ward KR, Witten TM, Bonchev DG, Diegelmann RF. Impaired wound healing. Clin Dermatol. 2007 Jan-Feb;25(1):19-25. doi: 10.1016/j.clindermatol.2006.12.005.

    PMID: 17276197BACKGROUND

  • WINTER GD. Formation of the scab and the rate of epithelization of superficial wounds in the skin of the young domestic pig. Nature. 1962 Jan 20;193:293-4. doi: 10.1038/193293a0. No abstract available.

    PMID: 14007593BACKGROUND

  • Ratz, J.L. Textbook of dermatologic surgery, (Lippincott-Raven, Philadelphia, 1998).

    BACKGROUND

  • Robinson, J.K. Surgery of the skin : procedural dermatology, (Elsevier Mosby, Philadelphia, 2005).

    BACKGROUND

  • Wolcott R, Dowd S. The role of biofilms: are we hitting the right target? Plast Reconstr Surg. 2011 Jan;127 Suppl 1:28S-35S. doi: 10.1097/PRS.0b013e3181fca244.

    PMID: 21200270BACKGROUND

  • Smack DP, Harrington AC, Dunn C, Howard RS, Szkutnik AJ, Krivda SJ, Caldwell JB, James WD. Infection and allergy incidence in ambulatory surgery patients using white petrolatum vs bacitracin ointment. A randomized controlled trial. JAMA. 1996 Sep 25;276(12):972-7.

    PMID: 8805732BACKGROUND

  • Chren MM, Lasek RJ, Flocke SA, Zyzanski SJ. Improved discriminative and evaluative capability of a refined version of Skindex, a quality-of-life instrument for patients with skin diseases. Arch Dermatol. 1997 Nov;133(11):1433-40.

    PMID: 9371029BACKGROUND

  • Tsao S, Yao M, Tsao H, Henry FP, Zhao Y, Kochevar JJ, Redmond RW, Kochevar IE. Light-activated tissue bonding for excisional wound closure: a split-lesion clinical trial. Br J Dermatol. 2012 Mar;166(3):555-63. doi: 10.1111/j.1365-2133.2011.10710.x. Epub 2012 Jan 19.

    PMID: 22032650BACKGROUND

  • van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.

    PMID: 16079683BACKGROUND

  • Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.

    PMID: 3450848BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Todd V Cartee, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

  • Joslyn S Kirby, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Dermatology

Study Record Dates

First Submitted

January 18, 2013

First Posted

January 23, 2013

Study Start

March 1, 2013

Primary Completion

March 16, 2020

Study Completion

October 16, 2020

Last Updated

November 1, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)